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Testosterone Replacement Therapy Market Size, Analysis, and Forecast Report 2019-2025 – StartupNG

Posted: August 27, 2020 at 2:56 pm

The report is an all-inclusive research study of the global Testosterone Replacement Therapy market taking into account the growth factors, recent trends, developments, opportunities, and competitive landscape. The market analysts and researchers have done extensive analysis of the global Testosterone Replacement Therapy market with the help of research methodologies such as PESTLE and Porters Five Forces analysis. They have provided accurate and reliable market data and useful recommendations with an aim to help the players gain an insight into the overall present and future market scenario. The Testosterone Replacement Therapy report comprises in-depth study of the potential segments including product type, application, and end user and their contribution to the overall market size.

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Segment by Type, the Testosterone Replacement Therapy market is segmented intoGelsInjectionsPatchesOther

Segment by Application, the Testosterone Replacement Therapy market is segmented intoHospitalsClinicsOthers

Regional and Country-level Analysis:North AmericaUnited StatesCanadaAsia-PacificChinaJapanSouth KoreaIndiaSoutheast AsiaAustraliaRest of Asia-PacificEuropeGermanyFranceU.K.ItalyRussiaNordic CountriesRest of EuropeLatin AmericaMexicoBrazilRest of Latin AmericaMiddle East & AfricaTurkeySaudi ArabiaUAERest of MEA

Competitive Landscape and Testosterone Replacement Therapy Market Share AnalysisTestosterone Replacement Therapy market competitive landscape provides details and data information by companies. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on sale and revenue by players for the period 2015-2020. Details included are company description, major business, Testosterone Replacement Therapy product introduction, recent developments, Testosterone Replacement Therapy sales by region, type, application and by sales channel.

The major companies include:AbbVieEndo InternationalEli lillyPfizerActavis (Allergan)BayerNovartisTevaMylanUpsher-SmithFerring PharmaceuticalsKyowa KirinAcerus Pharmaceuticals

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Testosterone Replacement Therapy Market Size, Analysis, and Forecast Report 2019-2025 - StartupNG

LPCN: Tlando: Target Action Date This Friday – Zacks Small Cap Research

Posted: August 27, 2020 at 2:56 pm

By John Vandermosten

NASDAQ:LPCN

READ THE FULL LPCN RESEARCH REPORT

Up and Coming Milestones

Tlando PDUFA date August 28, 2020

Primary endpoint results for LiFT (LPCN 1144) 4Q:20

Patent Infringement trial February 2021

Complete Phase II LiFT (LPCN 1144) 2Q:21

Second Quarter 2020 Operational and Financial Results

On August 6, 2020 Lipocine (NASDAQ:LPCN) filed its second quarter 2020 10-Q and posted its earnings release for the three month period ending June 30, 2020. The company reported zero revenues and a net loss per share of ($0.13) compared to prior year revenues of zero and loss of ($0.14) per share. Activity during the second quarter revolved around several items including presentation at the American Urological Association (AUA) conference, demonstration of treatment potential for LPCN 1144, investigational new drug clearance for LPCN 1148, affirmation of the USPTO decision and the dismissal of a shareholder lawsuit. The companys shares also exceeded $1.00 in June, and have remained above this level, allowing Lipocine to regain compliance with NASDAQ minimum bid requirements. The most important item on the calendar is the FDAs response to Tlandos NDA submission, which is expected on or before August 28th.

We anticipate that upon approval, Lipocine will find a partner to commercialize Tlando and use associated upfront and milestone payments to further develop the existing portfolio, especially LPCN 1144 and LPCN 1148. Potential licensees are waiting until approval is granted before performing their due diligence. This suggests that a deal would be announced in the fourth quarter of 2020 rather than in the weeks following an assumed approval.

Operational expenses for 2Q:20 were $4.2 million, up 26% and net loss totaled ($6.4) million or ($0.13) per share. Research and development expenses totaled $2.5 million. The 16% rise over prior year amounts reflects increased costs related to the LiFT study and higher personnel expenditures offset by a decrease in amounts related to the ABPM study, lower spend on the Tlando XR program and a fall in manufacturing costs for LPCN 1107. General and administrative costs rose 41% over last years second quarter to $2.0 million on an expansion in legal expenditures related to the Clarus dispute and an increase in personnel costs offset by lower marketing expenses, administrative travel and other expenses. A rise in the share price increased the warrant liability and required the recognition of a $2.1 million non-cash loss in other income.

Cash and marketable securities balance was $18.2 million as of June 30, 2020. There is another $5 million of restricted1 cash which will remain on hold until Tlando is approved. Current and non-current debt is carried on the balance sheet at $6.3 million. Cash burn for 2Q:20 was approximately ($4.1) million and net cash provided by financing was $11.7 million representing a stock offering and warrant proceeds partially offset by a small amount of debt repayment.

Tlando

On November 11 of last year, Lipocine announced that it had received a complete response letter (CRL) for Tlando. The CRL identified one deficiency stating that the trial did not meet one of the three secondary endpoints for maximal testosterone concentrations (Cmax). No deficiencies related to chemistry, manufacturing and controls were noted. FDA guidelines call for 85% of subjects to achieve a Cmax below 1500 ng/dL and no more than 5% of subjects presenting a Cmax between 1800 ng/dL and 2500 ng/dL and 0% above 2500 ng/dL. In the most recent dosing validation (DV) study, 85% of subjects were below 1500 ng/dL and 7% were between 1800 ng/dL and 2500 ng/dL. Although there were small variations from the FDA guidelines in the original SOAR study for subjects above 2500 ng/dL, the FDA did not identify these as a deficiency during the original New Drug Application (NDA) submission.

Following the Post Action meeting with the FDA, Lipocine was advised to address the outstanding deficiencies with a reanalysis of existing data. This recommendation relieved Lipocine of the time and cost of an additional trial and also allowed the resubmission of the Tlando NDA in February. A target action date of August 28th was provided. While the resubmission is a positive, Tlando has faced significant hurdles gaining the favor of the FDA. We published a note on February 25th that discussed details regarding the resubmission.

LPCN 1144

Lipocine announced in August 2018 the pursuit of a new indication in nonalcoholic steatohepatitis (NASH). We discuss the indication and Lipocines efforts in an earlier piece that can be accessed here. Full enrollment of 36 subjects was achieved in November 2018.

In January 2019, Lipocine announced meaningful liver fat reduction in patients participating in its Liver Fat Study and informed investors that the company had filed an investigational new drug (IND) application to begin a Phase II study for NASH. Since LPCN 1144 is the same molecule as TLANDO, for which there were numerous safety studies completed, LPCN was allowed to perform a proof of concept (POC) clinical study under the original IND to assess liver fat changes. This 36-person study was conducted in hypogonadal men at risk of developing non-alcoholic steatohepatitis (NASH) and results were measured using the magnetic resonance imaging proton density fat fraction (MRI-PDFF) technique. Topline results were announced in 1Q:19 demonstrating a 4.0% to 8.2% percentage point reduction in liver fat depending on baseline liver fat category. We discussed the results in further detail in our NASH Topline article.

Lipocine launched its Phase II clinical study for LPCN 1144 and dosed its first patient last September. Prior to the start of the trial, Lipocine announced that the FDA would allow the Phase II LiFT trial to enroll eugonadal patients in addition to the NASH patients that were initially targeted. This expansion was based on research that we discussed in a July 29th note. The study is anticipated to last for 18 months and cost approximately $8 million.

LiFT, an acronym of Liver Fat intervention with oral Testosterone, is a paired biopsy Phase II study in NASH subjects. The study design will employ a three-arm, double-blind, placebo-controlled structure and enroll approximately 75 biopsy confirmed male NASH subjects with a NAS2 score of greater or equal to four. The primary endpoint for the study is 12-week MRI-PDFF liver fat reduction and the first patient was enrolled in 3Q:19. As for the anticipated timeline, Lipocine expects top line liver fat reduction data in 4Q:20 as measured by MRI-PDFF at 12 weeks. Biopsy data at 36 weeks is expected to be available in the second quarter of 2021.

Exhibit I LiFT Study Timeline3

NASH Environment

A lot has happened in the NASH space in 2020. Genfit (GNFT) announced that it will halt development of elafibranor after it failed to distinguish itself compared to placebo earlier this year. CymaBay (CBAY) announced that the FDA had lifted the hold on seladelpars Phase II study last month. No evidence was found for liver injury for the drug and the trial is expected to resume. Intercepts (ICPT) OCA received a complete response letter from the FDA in late June noting that the agency remains uncertain that the benefits of the drug outweigh the risks. Viking (VKTX) is conducting the Phase IIb VOYAGE trial for VK2809 which is still ongoing. A bright spot in the space has been results from Akeros (AKRO) Phase IIb trial for efruxifermin in NASH which were announced June 30. The study found that 48% of patients had fibrosis improvement of at least one stage with a 62% response rate. Fibrosis improved by at least two stages for 28% of the group with a 38% response rate and 48% experienced NASH resolution without worsening of fibrosis across all dose groups.

LPCN 1148

Lipocine is preparing to develop its testosterone molecule to treat NASH cirrhosis patients. While the target market is smaller than that of pre-cirrhotic NASH, there are no other FDA approved products available. The inverse relationship between testosterone and sarcopenia and the increased risks of advancing NASH cirrhosis validates this pursuit. Pending funding, Lipocine plans to initiate a proof of concept trial to evaluate the potential of this candidate. The companys Investigational New Drug (IND) application was cleared by the FDA in May 2020. We anticipate Lipocine will launch the Phase II trial after the start of commercialization of Tlando and upon availability of sufficient capital to fund it. Management has guided to a 4Q:20 or 1Q:21 start.

Exhibit II Lipocine Pipeline4

Markman Hearing

On March 26th, Lipocine announced the outcome of the Markman Hearing, also known as a claim construction hearing. This meeting is an important precursor to a patent infringement lawsuit and provides the definitions of terms critical for a jurys determination on whether or not a patent has value. A patent should not be too specific, as it provides insufficient protection to an invention, or too broad, in which case a court may rule it indefinite. In the hearing order5, Judge Bryson did not agree with most of Clarus claims and sided with Lipocine on the majority of definitions and clarifications. While the terms and definitions are subject to an evolving construction, the order is favorable to Lipocines dispute against Clarus. While this order could be appealed again, it is unlikely in the opinion of Lipocines counsel. Lipocine and Clarus are currently engaged in the fact discovery phase of the lawsuit and the jury trial is anticipated to take place in February 2021. Lipocine need only prevail on one claim to merit damages, which places them in a strong position to succeed in the trial or provide incentive for Clarus to settle.

USPTO Decision Affirmed

The US Court of Appeals affirmed the decision of the USPTO in April 2020 to grant Lipocines Priority Motion in the interference case that cancelled Clarus claims to the 428 patent in January 2019. The USPTO, through its Patent Trial and Appeal Board (PTAB), had granted Lipocines priority motion in the related interference case and entered adverse judgment against Clarus. As we have previously shared, this outcome was expected as it is rare for a federal court to overturn a USPTO ruling. As a reminder, in 2Q:19 Lipocinefiled suitagainst Clarus alleging that Jatenzo infringed on six of Lipocines patents. The injunction filing may slow down commercialization of Jatenzo and force Clarus to come to the table to negotiate a settlement. While the cost of pursuing such legal action could be high, we anticipate by the time the case works its way through the courts, cash flow from Tlando could be sufficient to support the legal efforts.

Publications and Abstracts

Results from Lipocines Liver Fat Study were published in Hepatology Communications in an article entitled LPCN 1144 Resolves Non-Alcoholic Fatty Liver Disease In Hypogonadal Males." The study served to identify the prevalence of non-alcoholic fatty liver disease (NAFLD) in hypogonadal males and quantify the beneficial impact of LPCN 1144 on hypogonadism. 36 hypogonadal males were evaluated using MRI-PDFF measurements for liver fat. 81% of those with baseline liver fat equal to or greater than 5% showed improvement in liver fat content and NAFLD resolved in one-third of the group at six weeks and 48% after 16 weeks. The paper concluded that treatment with LPCN 1144 resolved NAFLD in about half of affected patients without any safety signals.

Lipocine submitted several abstracts to the American Urological Association (AUA) Virtual Experience, which took place from May 15 to 17, 2020. Three titles were presented.

Impact of a new oral testosterone undecanoate on blood pressure and cardiovascular risk was presented by Dr. Mohit Khera which investigated the chronic use of testosterone replacement therapy (TRT) on cardiovascular risk. Jatenzo, Xyosted and Tlando were assessed in their impact on blood pressure and cardiovascular risk in hypogonadal men. Marginal increases in blood pressure were observed and no meaningful impact on cardiovascular risk was noted.

A novel oral testosterone therapy restores testosterone to eugonadal levels without dose titration was presented by Dr. Martin Miner and highlights the shortcomings of dose titration when prescribing TRT. The abstract concluded that fixed dose Tlando normalizes testosterone levels in hypogonadal patients while avoiding the potential problems associated with titrated TRT.

Effects of a new oral testosterone undecanoate (TLANDO) therapy on liver was presented by Dr. Irwin Goldstein and compares oral methyltestosterone (MT) with TRT in males deficient in endogenous testosterone. The study results suggested that unlike MT, Tlando has no adverse effects on liver and can be used for an extended period to potentially reduce liver fat.

Milestones

Tlando CRL November 9, 2019

Tlando FDA post action meeting January 2020

Resubmission of Tlando NDA February 2020

Investigational New Drug (IND) clearance for LPCN 1148 May 2020

Wajda v. Patel shareholder suit dismissed July 2020

Tlando PDUFA date August 28, 2020

Primary endpoint results for LiFT (LPCN 1144) 4Q:20

Patent Infringement trial February 2021

Complete Phase II LiFT (LPCN 1144) 2Q:21

Summary

Since our previous update, Lipocine has participated in scientific conferences, published an article in the journal Hepatology Communications and advanced several months towards the upcoming August 28 PDUFA date for Tlando. Assuming a favorable outcome for the application, Lipocine will seek a commercialization partner and should receive upfront and milestone proceeds in conjunction with a deal. The Phase II LiFT trial continues to be a bright spot for the company and is potentially able to address a large unmet need in NASH patients in contrast to other programs which have met with difficulty. Management has guided towards a year-end readout of LiFT trial results. Lipocine is also developing LPCN 1148 for cirrhosis patients which was recently given clearance to begin a Phase II study. While we do not see this program entering the clinic until sufficient capital is available, we do think it will advance if Phase II data for LPCN 1144 are positive.

SUBSCRIBE TO ZACKS SMALL CAP RESEARCHtoreceive our articles and reports emailed directly to you each morning. Please visit ourwebsitefor additional information on Zacks SCR.

DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks provides and Zacks receives quarterly payments totaling a maximum fee of $40,000 annually for these services. Full Disclaimer HERE.

________________________

1. Tlando was not approved by the FDA by May 31, 2018, and therefore Lipocine is required to maintain $5.0 million of cash collateral at Silicon Valley Bank (the lender) until such time as it is approved by the FDA.

2. NAS: NAFLD (Non-alcoholic fatty liver disease) Activity Score. Discussion of the metric can be found here.

3. Source: Lipocine Corporate Presentation May 2020.

4. Source: Lipocine Corporate Presentation July 2020.

5. A link to the Markman Hearing Order can be found on this page: https://ir.lipocine.com/presentations

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LPCN: Tlando: Target Action Date This Friday - Zacks Small Cap Research

Doctors find testicles in woman’s stomach that are in early stages of cancer – Mirror Online

Posted: August 27, 2020 at 2:56 pm

A woman was 'devastated' when she found out the reason she'd never had a period is because she's intersex - after doctors discovered she was missing a womb and had testicles inside her stomach.

Content creator and activist, Dani Coyle, 25, from Swindon, grew up suspecting that something made her different. As a young teen, Dani's voice suddenly dropped and whilst her peers began to get their first periods, Dani only developed terrible stomach cramps.

After seeking medical advice, Dani was sent to specialists who at age 14, diagnosed her as being intersex. This means that Dani has a deviation in her gender characteristics that does not match the 'traditional' understanding of the female body.

Dani was told she had a 17 beta-hydroxysteroid dehydrogenase three deficiency. Whilst she'd always appeared to be female, Dani didn't have the female hormones she required once she reached puberty and 'should have' been born as a cisgender male. This is when a person's gender identification matches their birth sex.

The doctors discovered that Dani had XY chromosomes usually found in men and no female reproductive organs such as a womb. A further scan revealed that she has testicles inside her stomach which were in the early stages of cancer.

Doctors told Dani that they could 'normalise' her 'medical defect' through surgery and hormone replacement therapy. In 2009, the suspected cancerous testes were removed and Dani underwent external cosmetic surgery to alter the appearance of her vulva.

Dani thought that the ordeal was over, but she later felt coerced into the surgery after quickly learning that intersex bodies aren't accepted by society.

At school, Dani began to experience transphobic comments as her peers would deem her to be a 'lady boy' and a 'tranny,' due to a lack of understanding on what it means to be intersex. Whilst Dani uses both female and gender-neutral pronouns, she identifies as female.

"When I was told that I'm intersex, in truth, I was devastated although not surprised," Dani said.

"I'd wished for words to explain and understand my differences for a long time. I was relieved but scared to finally have them.

"When I was ten, I noticed things changing in my body that were more typical of what happens in male development. My voice lowered in tone and my period never came. It was an extremely confusing and lonely time.

"At fourteen, I was told I had 'seventeen beta-hydroxysteroid dehydrogenase three' deficiency.

"My body didn't respond 'normally' to the testosterone my testes produced which is why I was born, looked like, and was raised as a girl which is lucky as I've always identified as female.

"I was scared no one was going to love me when I found out. I was angry at the odds why me? I was told and believed it to be a secret that no one needed to know so I quickly underwent the surgery to remove my testes and normalise my external appearance just as the doctors and surgeons recommended.

"I also had hormone replacement therapy which is essentially a menopause oestrogen pill and I thought I'd be back to being a normal girl. Now, I feel like these surgeries were presented as the only viable option like I was robbed by biased doctors who work within a biased system which has caused an immeasurable amount of mental trauma."

Dani is a keen activist and she hopes to raise awareness around intersex surgery particularly surgery performed on young children without their consent. She believes raising awareness in society through extended education in schools could be a part of the solution.

"We are robbed of bodily autonomy in the name of gender binary," said Dani. "For many, the idea there are only two sexes and genders is way more convenient disregarding those of us who don't fit in to 'either' and 'or.' If I had known then what I do know, I wonder if I would have chosen the surgeries or harboured as much and shame and disgust for myself, as I did for so long.

"I used to think being intersex was a curse but now I see that's a blessing. I am free from the confines of gender expectations. I'm a part of the sanctuary of the LGBTQIA+ community and I'm literally one in a million.

"These surgeries are forced upon intersex babies every day, many of whom end up with a gender identity that doesn't align with their body's presentation because it was chosen for them by someone else.

"Even now, I have intimacy issues and body dysmorphia due to the trauma of being poked and prodded so much as a child ` it was incredibly traumatic.

"I want to see representative education in schools that covers the whole spectrum of human biology. I want to see the end of non-consensual, cosmetic intersex genital surgeries on babies and children.

"I want to promote and see the world become more aware, accepting, and inclusive of intersex, trans, and gender non-conforming people and our use of language. Hopefully, I can play a small part in that.

"The differences in our bodies, identities, and cultures are things to celebrate. Let's all be kinder to people who are different from ourselves."

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Doctors find testicles in woman's stomach that are in early stages of cancer - Mirror Online

Fasting Safely with Diabetes | NIDDK – National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Posted: August 27, 2020 at 2:55 pm

People with diabetes may wish to fast for dietary, medical, or religious reasons. Advance planning with a health care professional may reduce complications.

When Martin M. Grajower, MD, encountered patients with diabetes through his clinical practice who were committed to fasting for religious and other reasons, he was inspired to support them in finding ways to fast safely. Here, he discusses strategies that can help people with diabetes avoid health complications while fasting.

Q: What is a fast?

A: A fast is any defined period of time in which someone chooses not to eat. That could be six hours, eight hours, or 24 hours or more. A fast can mean no intake of food, or it can mean nothing at all by mouth, including no liquids.

Q: Why do people with diabetes fast?

A: People with diabetes fast for a variety of reasons, just like people without diabetes do. Most commonly today, people fast for dietary reasons. They want to lose weight, and so they may engage in calorie restriction by means of intermittent fasting.

People also fast for spiritual or religious reasons. For example, various religious practices call for fasting over a 24-hour period, over a certain number of hours per day for an entire month, or for one day a month throughout the year, or on some other schedule.

People may also fast because they have been told to do so before going into surgery. For example, sometimes people are told to eat nothing after midnight, but their surgery may not be until 3 oclock in the afternoon the next day, so thats a 15-hour fast. Some people going in for procedures, such as a bowel procedure, may be told to consume only liquids for 24 hours, which is also a form of fasting.

Q: What are the risks from fasting for people with diabetes?

A: Hypoglycemia is the number one risk. Hyperglycemia can also become an issue because people will cut back on their diabetes medicine, especially if theyre on insulin, to avoid hypoglycemia. But if they cut back too much, then their blood glucose will go too high and theyre at risk of hyperglycemia, and even potentially diabetic ketoacidosis.

Dehydration is another risk and depends on the nature of the fast. If its a complete fast where the person fasting cant take in liquids or has been instructed not to take anything orally to prepare for surgery, then dehydration becomes a major risk. The dehydration could be due to not drinking or because some diabetes medicines, such as the SGLT-2 inhibitors and diuretic medicines, induce diuresis. Furthermore, hyperglycemia induces diuresis.

Q: How do the different types of diabetes affect fasting risks?

A: People with type 1 diabetes are at greater risk when fasting compared to people with type 2 diabetes, because they are on insulin. The amount of insulin they take when fasting needs to be adjusted. If they dont cut back enough, they risk hypoglycemia, but if it is cut back too much, they can develop hyperglycemia. People with type 1 diabetes also face increased risk of dehydration and diabetic ketoacidosis, compared to people with type 2 diabetes. However, there are more people with type 2 diabetes, so at the population level there are more people at risk when fasting.

For women with gestational diabetes, if theyre not on medicine, especially if theyre not on insulin, fasting is the best insulin sensitizer that we have. So, I never hesitate to let women with gestational diabetes restrict calories for a short period. Pregnant women do have to factor in the risk of dehydration, taking into consideration their blood pressure and any edema.For women with gestational diabetes who wish to partake in the longer fasting regimen of certain religious practices, thats a separate discussion.

Q: What challenges does intermittent fasting pose for people with diabetes?

A: There are two types of intermittent fasting. Theres the type that you do every dayfor example, every day you eat for only eight hours during the day. I don't necessarily recommend it, but I have no problem with a person with diabetes following this eating pattern, because they're doing the same thing every day and you can just adjust their medications accordingly. The intermittent fasting where you fast two days a week or every other day is more problematic because it can become very complicated to adjust the medication. It can be done, but it requires the time and the expertise of the physician and it requires the compliance of the patient. So, I don't recommend patients do it on their own, but it can be done safely under medical supervision.

Q: What is your approach with patients who wish to fast for religious or spiritual reasons?

A: I became interested in this subject because of a couple of patients. A member of my religious community went to the rabbi and said, Last year my doctor said anyone with diabetes shouldnt fast, but I did anyway, on my own, and my sugar dropped low. So, what do I do this year? The rabbi called me up and asked what I should tell him. I found out that the only medicine this person was taking was a sulfonylurea, so I told him to stop taking his medicine 36 hours before Yom Kippur, and he did fine.

I also had an elderly Orthodox Jewish woman as my patient. I said to her, I dont think you should fast on Yom Kippur because youre elderly, youre on heart medicines, and youre on a complicated insulin regimen of three shots a day. She looked me straight in the eye and said, Doctor, I fasted on Yom Kippur in the concentration camps, so dont tell me not to fast now. Im going to fast with or without your help, but Im going to fast.

This was a powerful lesson. The determination to fast is found not just in the Jewish religion, but also in the Muslim faith. People hold Ramadan to be a very holy time, and theyre going to fast either with or without their doctors help. People of other faiths or who adhere to other spiritual or meditative traditions fast as well. Thats why I've become a very big proponent of allowing people with diabetes to fast, but under medical supervision.

Its our obligation as health care professionals to adapt diabetes to our patients religious beliefs. I did my fellowship under Dr. Harold Rifkin, who co-wrote the first textbook on diabetes. He taught me that you need to adjust the management of diabetes to the patients lifestyle, not the other way around.

I really think nurse practitioners and nutritionists could take the lead on this, because doctors unfortunately dont always have the time. If you have patients who are Jewish, Muslim, or a member of the Church of the Latter-day Saints, you can ask, Do you fast for religious reasons? And if they do, talk with them about how theyre going to manage it. Because if you dont ask the question, patients will do it on their own, and thats when theyre going to run into problems.

Q: What are the concerns when people must fast prior to surgery?

A: The major concerns are hypoglycemia and dehydration, both of which can be avoided by adjustment of medication and scheduling the surgery, for early in the day when possible.

Q: How do you help manage the patient who wants to fast?

A: Health care professionals need to consider the pharmacodynamics (mechanism of action) and pharmacokinetics (the onset and duration of action) of the diabetes medicine a patient is on. How long does the medicine work? How long does it stay in the system? Does the medicine increase hypoglycemia risk or is its action glucose dependent?

Sulfonylureas, the short-acting meglitinides, and insulin, are associated with hypoglycemia. The sulfonylureas have a 24- or 36-hour duration of action, so those need to be stopped at least 24 and preferably 36 hours before the patient is going to fast. Meglitinide and Nateglinide generally are taken three times a day before each meal because it has a duration of action of only 4-6 hours. Patients should not take a glinide medicine if theyre not eating or if theyre not going to eat carbohydrates.

Insulin requires a major adjustment, so the health care professional should understand the duration of action for the kind of insulin that the patient is on. For example, certain long-acting insulins are taken every day and have a duration of action of 36 to 42 hours. If a patient takes insulin on Monday, the effect is going to last until Wednesday. If I have a patient with this kind of insulin going in for a medical procedure on Tuesday, I advise him or her to reduce their dose of insulin on Sunday, two days prior, as well as on Monday, one day prior. I provide detailed instructions on how much to reduce the dosage, as described in the article on medication adjustment referenced below.

The older NPH (isophane) insulin has a duration of action of about 12 to 16 hours, and other forms of long-acting insulins have a duration of between 16 and 24 hours. For these medicines, you would have to help the patient adjust dosages mostly the day before the procedure.

Metformin, pioglitazone, and DPP-4 inhibitors rarely cause hypoglycemia, so health care professionals dont have to adjust them. But the patient should not take it on the day of fasting if its a 24-hour fast. With patients doing intermittent fasting, where they are eating during 8 hours of the day and going on a 16-hour fast, I dont tell them to stop taking the medicine, because they rarely cause hypoglycemia, and the medicine should be in their system for those 6 or 8 hours while they are eating to prevent hyperglycemia.

Q: What about dehydration concerns?

A: As far as dehydration goes, it really depends on the kind of fast. With intermittent fasting, fluid intake is never restricted; just calories are restricted. So, people with diabetes can drink water, diet soda, tea, or black coffee without hesitating, and dehydration should generally not be an issue. However, patients who normally get a lot of their liquids from foods like soups, shakes, jello, and yogurt may not realize that three-quarters of their fluid intake is really coming through food. Even if they drink as much while fasting as they do at other times, they will not be consuming enough liquid and they could run into a problem with dehydration.

Health care professionals also need to keep in mind that the SGLT-2s, besides lowering blood sugar, have a diuretic effect. Both aspects of the medicine must be considered when adjusting the dosages. I generally will stop the SGLT-2 two days before a patient begins a fast because of the dehydration aspect.

Health care professionals should also consider other medicines the patient is on, especially diuretics. These may also require adjusting. We also keep in mind the patients other medical conditions. A patient who has had a heart attack or a stroke within the last three months is at increased risk from dehydration and the resultant drop in blood pressure. If the patient becomes hypotensive from dehydration, this could lead to another heart attack or another stroke.

If A1C is not controlled, the patient is also at increased risk for dehydration, because glucose in the urine acts as a diuretic. If a patient has an A1C of 9 or greater, I will strongly discourage fasting due to the risk of dehydration from the high blood sugar or, if the patient has type 1 diabetes, the risk of going into diabetic ketoacidosis.

A patient who is running any fever in the last week or so should not be fasting, again because of the risk of dehydration resulting from fluid loss due to sweating. Health care professionals need to be conscious of these other issues before going ahead and giving a blanket recommendation regarding fasting.

Q: How do you advise patients regarding glucose monitoring during a fast?

A: Patients who are on insulin and fasting should do even more frequent glucose monitoring than usual until they get a sense of the safety of their revised insulin regimen. For example, the patient on a long-acting insulin who decides to intermittently fast two days a week, with the help of a health care professional, should adjust the insulin the day before the start of the fast. Then over the first two or three fasting periods, the patient should check glucose levels even more frequently than normal, until it can be established that the lower dose of insulin is correct. Subsequently, the normal frequency of testing can be resumed.

Someone whos not on a sulfonylurea or insulin doesnt have to test any more frequently than normal because the risk of hypoglycemia is extremely low.

Note: For detailed guidelines on medication adjustment and other considerations while fasting with diabetes, see the articles listed at the end of this interview.

Q: Do you have any other tips for helping patients with diabetes manage fasting?

A: At the time of a patients pre-fast visit, I write down all my instructions. I hand the patient a copy (to avoid misunderstandings), and I keep a copy in the patients chart. In the instructions, I put down medication adjustments, how often to check blood glucose readings, and what to do if the blood glucose reading goes above or below a certain specific number (individualized for the patient depending on age, the presence of hypoglycemia unawareness, and comorbid conditions). Soon after the fast, either at the next visit or via a follow-up telephone call, I ask the patient how he or she did. I make a note of that in the chart. The next time the fasting observance comes around, I look back at my previous note in the chart. If the patient did well, I simply make a photocopy and say, Here are your instructions. And for me, instead of spending 10 minutes, now it takes only 30 seconds.

Also, on the occasion when Ive told patients that I dont think they should be fasting, I ask permission to discuss it with their clergy. Youd be surprised how often a patient will let me do that. And then when their religious advisor tells them not to fast, they feel much more comfortable about it.

Guidance on fasting with diabetes by Dr. Grajower and others:

How do you address the subject of fasting with your patients who have diabetes?

More here:
Fasting Safely with Diabetes | NIDDK - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Why Ayurveda experts are encouraging diabetics to eat black rice? – TheHealthSite

Posted: August 27, 2020 at 2:55 pm

A healthy-eating plan is crucial for managing diabetes. People with diabetes are advised to stay away from foods that can spike their blood sugar levels such as sugary drinks, refined carbs, trans fat, dried fruits, etc. The best foods for diabetics are those that are low in carb and sugar, and high in fiber, healthy fats, and protein. One of the less popular, but nutritious foods for diabetes is black rice. Ayurveda experts claim that eating black rice can prevent the development of diabetes, cancer, heart disease, and even weight gain. Keep reading to know why you should be adding black rice to your diabetic diet. Also Read - 5 natural food sources of chromium, the nutrient that regulates blood sugar levels and more

Black rice, also known as purple rice or forbidden rice, has been eaten in Asian regions for centuries. Its said that in ancient China, black rice was forbidden for all but royalty. In India, it is commonly grown in the northeastern parts of India. Today this type of rice is gaining popularity across the globe as people discover the numerous health benefits it has to offer. Also Read - High carb, plant-based diets improve blood sugar levels in type 1 diabetes

Black rice is rich in powerful disease-fighting antioxidants, dietary fiber, protein, and iron. This type of rice gets its signature black-purple color from anthocyanins, a group of flavonoid plant pigments that have strong anti-inflammatory, antioxidant, and anticancer effects. Anthocyanins can act against free radicals and help diabetics get protection from cell damage and fight inflammation. Black rice is also rich in fibre, which is digested slowly by the body. This, in turn, helps in the slow release of glucose in the blood, preventing any sudden spikes in blood sugar levels. Fibre keeps you feeling full for longer and helps reduce calorie intake. This helps fight obesity, which is a risk factor for diabetes. Also Read - Add oatmeal and vitamin C-rich foods to your diet to bring down your risk of type 2 diabetes

However, it is advisable to consult your nutritionist or dietitian before adding black rice to your diabetic diet. They can tell you the exact amount of black rice that you can safely include in your daily meals. Besides a healthy-eating plan, diabetics should engage in some physical activity to regulate their symptoms.

Black rice can provide more health benefits than other closely related rice varieties.

Some studies that black rice may help prevent fatty liver disease, most likely due to its high antioxidant content. Excessive fat in your liver can cause liver inflammation, which can damage your liver and create scarring, and even lead to liver failure.

Many of the antioxidants found in black rice have been shown to help protect against heart disease. For example, flavonoids have been associated with a decreased risk of developing and dying from heart disease.

Some research suggests that the antioxidant anthocyanin in black rice can decrease build-up of atherosclerotic plaque in the arteries. The blockage of arteries is a major risk factor for heart attack and a stroke.

Black rice contains high amounts of lutein and zeaxanthin, which can protect your eyes from potentially damaging free radicals. Studies have found that these compounds can help protect the retina by filtering out harmful blue light waves.

Published : August 27, 2020 8:26 pm

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Why Ayurveda experts are encouraging diabetics to eat black rice? - TheHealthSite

Men are increasingly taking health and nutrition seriously – Hanford Sentinel

Posted: August 27, 2020 at 2:53 pm

Certain notions regarding nutrition and diet prevail even in the wake of research that suggests they shouldn't. For example, it has long been assumed that females diet and men give little thought to the foods they consume. But many such assumptions no longer hold water.

Recent evidence shows that men diet, too, and many men perhaps spurred on by a recent health crisis or a desire to be as healthy as they can be have taken much more informed and active roles in regard to their diets.

Data from the National Institute of Diabetes and Digestive and Kidney Diseases says around 73.7 percent of men in the United States are considered to be overweight or obese. This may be driving the fact that more than one in three U.S. consumers followed a specific diet or eating pattern in 2018, according to the Annual Food and Health Survey, released by the International Food Information Council Foundation. In 2016, a survey of more that 2,000 adults in the United Kingdom, conducted by the retail analysts Mintel, uncovered that almost half of Brits tried to lose weight in the year prior. However, 42 percent of male respondents and 33 percent of female participants reported being unaware of how many calories they were consuming each day.

As more men take control of their eating habits, these strategies can help them achieve optimal health.

Change the name. Men are often drawn to regimens that will help make them better at sports or increase energy. Referring to such changes as "food plans" or "lifestyle plans" may prove more effective than calling them "diets."

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Men are increasingly taking health and nutrition seriously - Hanford Sentinel

Jason Derulo, Who Drinks Salmon Smoothies and Deadlifts Golf Carts – GQ

Posted: August 27, 2020 at 2:53 pm

I like cardio less in my 30s, I think. Its just kind of become less and less of my thing. I like my bigger stature, and as soon as I do too much cardio I get too slim. Its a really tough balance for me, because I like to be strong. I like to at least be able to work out with 315 off my chest bench. As soon as I start slipping from that, I know I need to eat more, I know I need to get back on it. I'm always just trying to be the optimum version of myself, from all angles.

Does working out in the morning help stimulate your creativity for the rest of the day?

I think I would have good ideas if I didn't work out. But it's important for mental health. And the better you feel, the more proactive you can be. When I work out, I feel really good for the day.

Do you take off days?

I try to tell myself to work out every day and then the off days end up just end up happening because of circumstance, because I'm busy or something. But I usually at least end up working out five to six times a week.

In 2012 you suffered a pretty intense neck injury during a tour rehearsal. How did that happen?

I was preparing for my world tour and I slipped during a back tuck. The coach was preparing me to do them back to back to back, and he asked me to do, like, ten of them, and I guess I got tired and bailed on one. Youre not supposed to bail cause if you bail youre fucked. And it was not on mats. We were outside, which is the biggest mistake.

Being healthy probably saved my life. I always was into fitness, partly for vanity and partly just being an athlete at heart, but after the neck injury it was like, damn, I could have really lost my life if I wasnt healthy. So it kicked things into gear. Also, I spent seven months not being able to work out, and when you have something taken away from you, when you get It back, youre, like, Oh, shit, I really just wanna go for gold.

Do you work out with a trainer?

I work out with my cousin, who acts as a trainer. We have this really competitive relationship, so it works well for me. When I work with other trainers, I just don't get the best out of myself. He pushes me hard. When he goes hard Im gonna go harder and vice versa, so it ends up being the best kind of workout. And the most fun.

Last year you posted a video of yourself pulling a car on Instagram. What kinds of workouts do you do when you get bored of cardio or weightlifting?

I like to have fun and do different things, whether it's beach workouts, running football routes. I love boxing. I love pulling shit. Lifting carts, all kinds of like weird things, especially being at home, where I can be a lot more creative. I have an 8-seater golf cart that I do deadlifts with. And I pull a Jeep. Those are more like specialty days, which are even more fun. But I box regularly, and I lift weights every day.

What do you eat to fuel all these sessions?

My diet changes pretty often. I've done everything under the sun. I used to blend my salmon and have a salmon shake. I did all kinds of crazy shit. Sometimes I would literally just eat a bunch of eggs. Eggs and veggies. I went vegan, vegetarian, pescatarian. What works the best for me is when I intermittent fast and just do a high protein diet.

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Jason Derulo, Who Drinks Salmon Smoothies and Deadlifts Golf Carts - GQ

These simple hacks will make you fall in love with plant-based cooking | Dished – Daily Hive

Posted: August 27, 2020 at 2:53 pm

Spending more time at home over the past few months has prompted us to take a closer look at our eating habits.

Were interested in adding more plant-based options to our diets; that part were sure of. But its often difficult to know where to start, what to buy at the grocery store, and how to elevate dishes yourself.

Many Canadians have already made the switch to plant-based diets; in fact,BC has the highest share of vegans and vegetarians over any other province in the country.Whether youre transitioning to a new diet, limiting your meat consumption, or curious about how to stock a vegan-friendly pantry, you have options withplant-based alternatives.

The experts at Vancouvers socially conscious plant-based meat company,TMRW Foods, know a thing or two about vegan-friendly cooking, so we asked them to share their top hacks with us.

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After a night of sleep, our bodies need a satisfying breakfast to kickstart the day and give us the energy to go about our morning tasks. While you might assume that a plant-based diet limits your options, but this simply isnt the case.

If anything, those who love to eat big portions can rejoice. Vegan foods are less calorie dense than animal-derived products, so its important to eat a greater volume of food when going plant-based. Thankfully, its easy to stock your pantry and fridge with ingredients that work for all kinds of vegan breakfast recipes.

For a boost of protein in the early AM when you need it most, items like TMRW mince or firm tofu are great to include in something hearty like a breakfast burrito. One thing we love about the TMRW Mince is that it cooks quickly and caramelizes in the pan ideal for mornings when youre short on time but still want something delicious and satisfying.

To achieve that quintessential breakfast flavour in your burrito, a great tip is to add nutritional yeast (its high in B vitamins and adds an almost cheesy finish), and black Himalayan salt(it contains trace minerals like sulphur, making it great for creating a more eggy flavour).

For those who enjoy a sweeter start to the day, the vegan options are bountiful as well. We recommend doing overnight oats, which are hearty and filling, or chia seed pudding, which is high in omega-3s. These are easy and quick to make, and they taste better when prepped the night before and left in the fridge overnight.

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If youre working from home, you know just how easy it is to throw your diet plans into the ocean in favour of a quick noodle soup lunch. However, preparing a vegan-friendly lunch doesnt need to take hours. You can even prepare a big helping ahead of time to last you a couple of days.

One way of doing this is to bulk-buy produce and challenge yourself to find creative ways to use it. There are tons of YouTube tutorials on how to start juicing, fermenting, pickling, caramelizing, powdering, and dehydrating foods.

Start with ingredients that you can have some fun with. Strawberries, for example, can be fermented to make jam. You can let ginger or garlic dehydrate and turn either of them into a powder to use in juices or soups, and it doesnt take long to make some pickled onions.Expect a super flavourful and versatile addition to your lunches.

Another quick idea we love is using chickpeas as an alternative to tuna for a fibre and protein-rich lunch. For a vegan tuna salad sandwich, mash up a handful of chickpeas, add some vegan mayo, chopped celery, and a few sprinkles of old bay seasoning. These simple additions can take your lunch to the next level!

At the end of a long day, the temptation to order takeout is real. Butwhen you can emulate the restaurant experience with easy-to-prepare food at home (and save money at the same time), dinner tastes even better. Serving upbrag-worthy burgers and homemade fries is just the beginning.

Were big fans of the TMRW Burger because it definitely hits the spot when youve got a serious burger craving, while still keeping things balanced with the inclusion of wholesome plant ingredients like quinoa, split peas, and kidney beans. The best of both worlds!

To keep your evening meals as nutritious as possible, think about integrating everyday ingredients likemushrooms (high in vitamins B and D), yams (for potassium), and tomatoes (vitamin C). Tip: To make sure youre increasing your iron absorption, always add a source of vitamin C to your meal. This can be anything from fresh tomatoes or peppers to a squeeze of lemon.

Browsing local farmers markets for produce allows you to find inspiration for vegan-friendly dinners and desserts youll typically find locally-made vegan treats that you wont find at the grocery store, too.

With your ingredients down, prepare some easy-to-make-vegan Asian dishes that you can also store in the freezer for later in the week. Looking for a new spin on your favourite Mexican dishes? Simply replace the meat withrefried or black beans. Dont forget the vegan mayo on the side you can make your own usingsunflower oil, soy milk, apple cider vinegar, and salt. Dining at home could have a whole new, delicious meaning for you.

Exploring plant-based alternatives doesnt have to be a daunting experience nor does it have to mean giving up the food you love.

You just have to get a little creative and plan ahead so that when you open your fridge, youve got plenty of options. The world is your oyster (well, oyster mushroom).

For more information about Vancouvers TMRW Foods and to find a stockist near you, check outtmrwfoods.com.

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These simple hacks will make you fall in love with plant-based cooking | Dished - Daily Hive

Reverse dieting: slowly increasing calories won’t prevent weight regain but may have other benefits – The Conversation UK

Posted: August 27, 2020 at 2:53 pm

While there are many debates about which type of diet is best for weight loss and health, its often not the weight loss which is the biggest challenge, but rather avoiding weight regain afterwards. This can lead to cycles of dieting and weight gain, or yo-yo dieting, which can cause people to have a less healthy relationship with food, worse mental health and a higher body weight.

But recently, reverse dieting has gained popularity online as a post-diet eating plan that claims it can help you avoid weight regain by eating more. In simple terms, its a controlled and gradual way of increasing from a low calorie weight-loss eating plan back to your more normal pre-diet way of eating.

The idea with reverse dieting is that gradually increasing calorie intake following a deficit will allow your body and your metabolism to adjust so that you can avoid weight regain while eating more. However, there is currently no scientific evidence showing that reverse dieting works as advocates claim.

Reverse dieting is based around the theory that our body has baseline set points for metabolism and calorie intake hardwired into our biology, and if we go above these points we gain weight. The idea is that reverse dieting can shift these set points upwards if a person slowly increases the amount of calories eaten as food. This would theoretically boost their metabolism, allowing them to consume more food and calories without gaining weight.

However, the idea that as humans we have a set point, which we can manipulate with dietary changes, is not supported by research. The main reason for this is because a number of factors influence our weight and metabolism, including how it changes. Among them are how were brought up, what food we have access to, what type of exercise we do, and our genetics.

But the most important influence over how our body uses calories and therefore our weight is our resting (or basal) metabolic rate. This is the amount of calories our body needs in order to keep itself alive. This accounts for about 60%-70% of the calories we use daily.

Our basal metabolic rate is mostly determined by our age, weight, sex and muscle mass your diet has little effect on it. Eating at or below your basal metabolic rate will result in weight loss, and eating above it will result in weight gain. Our basal metabolic rate also increases as we gain weight or muscle mass, and decreases as we lose weight or muscle mass (the evidence shows that the more muscle your body has, the more calories it needs to function).

Exercise also increases how many calories we use, but usually not enough to massively affect our weight. And though a high protein diet can alter metabolic rate somewhat, our body weight and muscle mass have the greatest effect on it.

So reverse dieting only appears to work by controlling calorie intake. Theres currently no evidence that you can alter your metabolism or metabolic rate by introducing more calories slowly and gradually. Put simply, if you eat more calories than your body requires, you will gain weight. What we do know is that certain habits, like regularly eating breakfast and exercise, help people avoid weight regain after dieting.

While theres currently little research investigating the effects of reverse dieting on metabolism, it could still help people in other ways. When some people are losing weight, they may feel in control of how they eat. But for some people, stopping their diet could lead to perceived loss of control. Reverse dieting might give some people the confidence to return to a more sustainable way of eating, or help them move out of a cycle of restrictive dieting.

Advocates of reverse dieting suggest it can also help manage problems of appetite and cravings. This is because additional foods can be added in as the amount of calories and food eaten is increased. While fewer cravings can help with weight maintenance, this evidence does not come from studies where foods were slowly reintroduced.

For some people, counting calories or restrictive dieting can tend to lead to an unhealthy relationship with their bodies and the food they eat. Orthorexia nervosa is becoming increasingly common, and is characterised by an obsession with eating healthy which can lead to an unhealthy restriction of and relationship with foods. While wanting to eat a healthy diet can seem on the surface to be a good thing, when it becomes orthorexia and enjoyment of food is replaced by an anxiety of feeling the need to account for every calorie, this could lead to poor mental health.

Reverse dieting is one approach, but some would argue other methods, such as intuitive eating which emphasises listening to your bodys hunger cues and only eating when youre hungry might be psychologically healthier. Intuitive eating may help people both regain and trust their appetites, and stop the cycle of restriction and calorie counting.

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Reverse dieting: slowly increasing calories won't prevent weight regain but may have other benefits - The Conversation UK

Constant dieters might be choosing the wrong way to lose weight – The Conversation US

Posted: August 27, 2020 at 2:53 pm

The Research Brief is a short take about interesting academic work.

Dieters looking for a healthier substitute of their favorite high-fat food such as a bag of potato chips typically have two choices in the grocery aisle: a smaller package of the exact same food or a larger portion of a light version. In a series of studies, we put this choice to consumers and found that people who frequently try to cut back on their eating or are essentially always on a diet known as restrained eaters prefer the larger portion size of the light version, even though both contained the exact same number of calories. Participants who indicated that they rarely dieted tended to pick the smaller size with the full flavor.

Our first study involved a vending machine choice between a medium-sized bag of Lays Baked BBQ potato chips and a smaller package of the regular version both 150 calories. Participants who took a survey in which they reported frequently trying to cut back on their eating for example, by taking smaller servings and skipping meals opted for the larger bag of baked chips. We got similar results over four additional studies involving other snacks, such as popcorn and cookies.

People tend to want food to be tasty, healthy and filling. Our studys restrained eaters were definitely interested in choosing a snack that seemed healthier, but their choice of the larger size suggested they wanted a snack that they felt would make them feel full as well possibly at the expense of taste. Feeling full can help people consume fewer calories overall.

The problem is research suggests eating more of lighter foods might not make people feel full, and this may point to a reason why most diets fail. Some psychologists argue that restrained eaters do not achieve the health and weight outcomes they desire possibly because, in depriving themselves of the fattier, tastier food, they may later engage in binge-eating or overconsume.

By opting for the lighter, less pleasurable food, even in larger packages, restrained eaters might be depriving themselves of the food they actually crave regular chips, buttered popcorn or a sugary cookie.

More research is ultimately needed, however, to test whether the emphasis on increasing the portion sizes that one can eat of light foods, rather than focusing on eating smaller portions of foods that are more satisfying, is a successful long-term strategy. Or, as past research indicates, might it actually backfire and contribute to failed dieting? Its still not entirely clear.

At the moment, we are working on new research examining how people decide what to eat, how much to eat and how frequently to eat it. For example, why do some people decide to try to avoid any treats, whereas others try to seek moderation? If they seek moderation in their diet, would they rather have a small treat every day or have a cheat day on the weekend?

Were also trying to understand whether or not consumers actually feel as full as they think they do by eating more lighter foods rather than less of calorie-dense foods.

We use a variety of approaches in our research on food, including conducting lab and online-based experiments, field studies and exploring existing data sets, such as food diary data. For this particular research, we recruited participants to pick chips out of a vending machine and used online panels to simulate real-world choices.

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Constant dieters might be choosing the wrong way to lose weight - The Conversation US


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