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FDA approves oral testosterone replacement therapy for hypogonadism – Urology Times

Posted: August 9, 2022 at 2:12 am

The FDA has approved Kyzatrex, an oral testosterone replacement therapy for the treatment of adult males with conditions associated with hypogonadism.1

The approval was based on results from the multicenter, open-label phase 3 Study MRS-TU-2019EXT (NCT04467697). The study enrolled 155 hypogonadal males. According to the study design, The primary efficacy end point was the percentage of KYZATREX-treated patients with mean plasma total testosterone concentration over 24-hours within the normal range of 222-800 ng/dL on the final PK visit of the study at day 90.2

Of the total patient population, 139 patients were eligible for the efficacy analysis The median patient age was 50 years (range, 22-66). Regarding race, 79% of patients were White, 16% were Black, 3% were Asian, and 2% were American Indian, Alaskan Native, or other.

Overall, 88% (122/139) of patients reached the primary study end point. The key secondary endpoints were the percentage of patients who had a maximum total testosterone

concentration that met 3 predetermined limits: 1.5 times the upper limit of normal range (ULN; 1200 ng/dL); 1.8-2.5 times ULN (1440-2000 ng/dL); and >2.5 times ULN (2000 ng/dL). At the final PK visit, these percentages were determined to be88%, 4%, and 0%, respectively.

The mean duration of treatment exposure was 168 days (range, 1-180). The only adverse event occurring in 2% of patients was hypertension, which was reported in 4 (2.6%) of 155 patients.

With so many men suffering daily effects of Testosterone Deficiency and often abandoning or not electing to get treatment, we see FDA-approved Kyzatrex as a newly viable oral option that has demonstrated safety and effectiveness. Further, Testosterone Deficiency is a big blind spot in medicine today and our research will continue to explore the importance of testosterone in both male and female health, Shalin Shah, CEO of Marius, the developer of Kyzatrex, stated in a news release.

References

1. Marius Pharmaceuticals Receives FDA Approval of KYZATREX, an Oral Testosterone Replacement Therapy. Published online August 2, 2022. Accessed August 3, 2022. https://bit.ly/3OUA0Cx

2. FDA prescribing label for Kyzatrex (testosterone undecanoate) capsules, for oral use. Accessed August 3, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213953s000lbl.pdf

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FDA approves oral testosterone replacement therapy for hypogonadism - Urology Times

FDA Weekly Review: Gamida Cell, Cellectis, Scynexis and More – BioSpace

Posted: August 9, 2022 at 2:12 am

Sarah Silbiger/Getty Images

The U.S.Food and Drug Administrationhas had a busy week, accepting drug applications, approving clinical trials and granting various special designations. Continue reading for more details.

Bayerreceived a nod from the FDA for the use of Nubeqa (darolutamide) in combination with docetaxel chemotherapy for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). This follows a previous approvalof Nubeqa in non-metastatic castration-resistant prostate cancer (nmCRPC). The newest approval isbased on the Phase III ARASENS trial, which studied Nubeqa plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel.

The FDA approvedDaiichi SankyoandAstraZenecas ENHERTUfor another indication. It is now approved for the treatment of adult patients with a range of HER2 expressions, including those with unresectable or metastatic HER2 low breast cancer. This additional indication was based on theDESTINY-Breast04Phase III trial.

Gamida Cell Ltd.announcedthat the FDA accepted its Biologics License Application for omidubicel. The therapy is being developed for the treatment of patients with blood cancers who need an allogeneic hematopoietic stem cell transplant.

Cellectisreportedthe FDA cleared its Investigational New Drug (IND) application to initiate a Phase I/IIa trial of UCART20x22 for patients with relapsed or refractory Non-Hodgkin Lymphoma (r/r NHL). UCART20x22 features TALEN-mediated disruptions of the TRAC gene and of the CD52 gene.

Scynexisannouncedthat the FDA accepted its sNDA for Brexafemme for the treatment of vulvovaginal candidiasis (WC) and the prevention of recurrent WC. It was accepted for Priority Review with a PDUFA date of November 30, 2022.

The Janssen Pharmaceutical Companies of Johnson & Johnsonannouncedthe FDA approved Stelara (ustekinumab) for the treatment of children six and older with active psoriatic arthritis (PsA). The drug is a fully human monoclonal antibody that selectively inhibits IL-12 and IL-23.

Krystal Biotechreportedthat the FDA had accepted its IND application for KB407 for cystic fibrosis. KB407 is a modified HSV-1 vector carrying two copies of the CF transmembrane conductance regulator (CFTR) gene to the respiratory cells in the lungs.

Beam Therapeuticsannouncedthe FDA placed a clinical hold on its IND application for BEAM-201 for relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T cell lymphoblastic lymphoma (T-LL). No reason for the hold was supplied. BEAM-201 is a donor-derived CAR-T cell therapy that has undergone multiplex base editing to become universally compatible and resistant to rejection by the host.

Celyad Oncologyreportedthe FDA has lifted its clinical hold on the Phase Ib KEYNOTE-B79 trial. The hold was placed in February after two patient deaths. CYAD-101 is an allogeneic CAR-T cell therapy designed to express the NKG2D receptor, generally found on NK cells, and the novel inhibitory peptide TIM. It is being tested with Mercks Keytruda.

Marius Pharmaceuticalsannouncedthat the FDA approved Kyzatrex (testosterone undecanoate) as an oral testosterone replacement therapy for adult males for conditions associated with deficiency or absence of endogenous testosterone (hypogonadism).

MAIA BiotechnologyreceivedOrphan Drug Designation from the FDA for THIO. THIO is a telomere-targeting agent in development for multiple cancers, including small-cell lung cancer.

BiosightwasgrantedOrphan Drug Designation by the FDA for asparcytarabine for treatment of myelodysplastic syndromes. Asparcytarabine is a novel proprietary anti-metabolite made up of cytarabine covalently bound to asparagine.

Calidi Biotherapeuticsannounced thatCity of HopereceivedFDA authorization to proceed with a Phase I trial of Calidis oncolytic virotherapy platform, NSC-CRAd-S-pk7. The therapy is made up of tumor-tropic neural stem cells delivering an oncolytic adenovirus selectively to tumor sites in patients with recurrent high-grade glioma.

Twist BioscienceandBiotias EUA for its Next-Generation Sequencing Assay for SARS-COV-2receivedexpanded authorization.

Avenge Bioannouncedthe FDA cleared its IND for AVB-001 in peritoneal malignancies. The drug is designed to secrete native IL-2 in immune-activating alginate capsules.

Amylyx Pharmaceuticalsreportedthat the FDAs Peripheral and Central Nervous System Drugs Advisory Committee will reconvene to review its NDA for AMX0035 (sodium phenylbutyrate and taurursodiol) for ALS. It previously met on March 30 but is reconvening to discuss additional data analysis.

Allergan Aesthetics, an AbbVie company,announcedthe FDA approved Juvederm Volux XC for the improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.

AnHeart TherapeuticsreceivedBreakthrough Therapy Designation from the FDA for taletrectinib for adults with advanced or metastatic ROS-1-positive non-small cell lung cancer (NSCLC) who are ROS1 TKI treatment nave or previously treated with crizotinib. Taletrectinib is a ROS-1 inhibitor.

OliX Pharmaceuticalss IND for OLX10212 wasapprovedfor age-related macular degeneration. OLX10212 targets inflammation pathways that play a key role in geographic atrophy and neovascular AMD. It is for a Phase I trial.

Sumitomo Pharma Oncologyreportedthe FDA granted Orphan Drug Designation for DSP-5336 for acute myeloid leukemia. The drug is a small molecule inhibitor against the binding of minin and mixed-lineage leukemia (MLL) protein.

Pulse Biosciencesannouncedthey had received FDA clearance of expanded energy settings for use with the family of CellFX System treatments tips in dermatology. CellFX System uses the companys Nano-Pulse Stimulation technology to deliver electrical energy to clear cells.

Vaxcytereportedthe FDA granted Fast Track designation to VAX-24, its 24-valent pneumococcal conjugate vaccine candidate for adults 18 and older.

GenBody Americaannouncedthat the FDA granted an extension of the shelf life for its COVID-19 Ag (antigen) test from 12 months to 21 months when stored at 2 to 30 degrees C (35-86 degrees F).

Acadia Pharmaceuticalsannouncedthey had received a Complete Response Letter from the FDA for its sNDA for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with Alzheimers disease psychosis (ADP). The agency recommended that the company run another trial in ADP.

ProfoundBioreceivedthe go-ahead from the FDA for its IND to evaluate PRO1184 in patients with advanced cancer in a Phase I trial. The drug is an antibody-drug conjugate made up of a folate receptor alpha directed antibody conjugated to an exatecan payload with a proprietary hydrophilic linker.

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FDA Weekly Review: Gamida Cell, Cellectis, Scynexis and More - BioSpace

Testosterone Replacement Therapy Market: Increasing Incidence of Testosterone Deficiency to Drive the Market – BioSpace

Posted: August 9, 2022 at 2:12 am

Wilmington, Delaware, United States, Transparency Market Research Inc.: According to Transparency Market Researchs latest report on the global testosterone replacement therapy market for the historical period 20172018 and forecast period 20192027, increasing incidence of testosterone deficiency, growing awareness among people regarding testosterone replacement therapy and significant pipeline of medications, are projected to drive the global testosterone replacement therapy market during the forecast period

According to the report, the global testosterone replacement therapy market was valued at US$ 1,613.7 Mn in 2018 and is anticipated to expand at a CAGR of 4.4% from 2019 to 2027

Rising incidence of testosterone deficiency: Key Drivers

Testosterone deficiency, also known as hypogonadism, is characterized by diminished functioning of the male gonads that reduces testosterone secretion. This occurs mainly due to hypothalamic-pituitary axis dysfunction and/or testicular failure.

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Testosterone deficiency is one of the common health problems among men aged between 40 years and 79 years. The incidence of low testosterone levels in men aged over 60 years is estimated to be around 20% of the male population, and in population aged over 70 years, around 30%. The global prevalence of testosterone deficiency ranges from over 10% to 40% of the population.

However, only around 9% patients with testosterone deficiency are being treated in the U.S. This is due to factors such as perceived risk of prostate cancer associated with current treatment therapy and lack of screening/tests for low testosterone. Therefore, increase in incidence rate of testosterone deficiency is expected to drive the testosterone replacement therapy products market in the near future.

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Rise in Geriatric Population with High Risk of Testosterone Deficiency Boost Market Growth

The world population is aging rapidly, especially in some of the developed economies such as the U.S., most of Western Europe, and Japan. Developed economies present high rates of aging. This is attributed to improved health care infrastructure, policies, and advancement in health care facilities in these countries. Moreover, access to various diagnostic and treatment services has improved in the recent past especially in developed economies. This in turn has increased the life expectancy of the population.

According to World Health Organization (WHO) estimates, the global geriatric population is likely to reach around 2 billion (22% of global population) by 2050 as compared to 524 million in 2010. The geriatric population would rise at the fastest rates in developed countries such as the U.K, Germany, the U.S., and Japan. However, Brazil, China, Thailand, and South Korea are also expected to have a large geriatric population base in shortest span of time in the near future.

Testosterone levels decrease naturally as age increases beyond 30 years. However, in some cases significant decrease can lead to health problems. World population is rapidly aging. Therefore, with increasing population of age individuals the testosterone deficient men population would also grow, which in turn would increase the demand for testosterone replacement therapy in the global market. Hence, increase in the geriatric population is expected to fuel the growth of the testosterone replacement therapy market globally.

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Patent Expiry of Key Drugs and Entry of Generics Hamper Market

The testosterone replacement therapy market is expected to experience a patent cliff during the forecast period. Expiration of key drug patents would affect the revenues of large pharmaceutical companies from TRT products. In addition, the generic versions of these drugs would further reduce the global market revenues as these would be priced much lower than their counterparts (branded drugs) that dominated the global market earlier.

This factor is expected to have a profound effect on the overall testosterone replacement therapy products market, causing a drastic dip in market revenues. Moreover, approved ANDAs for most of these molecules will lead to intense generic competition.

Therefore, patent expirations are likely to significantly impact and restrain the testosterone replacement therapy market in the near future.

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Global Testosterone replacement therapy Market: Competitive Landscape

This report profiles major players in the global testosterone replacement therapy market based on various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments

The global testosterone replacement therapy market is highly consolidated, with top five players accounting for over 60% of the market.

Leading players operating in the global testosterone replacement therapy market are

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Testosterone Replacement Therapy Market: Increasing Incidence of Testosterone Deficiency to Drive the Market - BioSpace

The Benefits of Intuitive Eating vs. Dieting – Cleveland Clinic Newsroom

Posted: August 9, 2022 at 2:11 am

CLEVELAND With so many diets out there these days, its easy to get overwhelmed.

But, Susan Albers, PsyD, psychologist for Cleveland Clinic, said it doesnt have to be that way and suggests switching to intuitive eating instead.

It is about making peace with food. Its about learning how to listen to your body, how to honor your hunger and deciding what to eat, she said. And this is such a tricky task. Of the patients I work with, the number one thing people come in saying to me is, I dont know what to eat.

Dr. Albers said intuitive eating is very different from traditional dieting.

When it comes to traditional dieting, an individual is given a set of rules to follow to help lose weight. Whereas with intuitive eating, you learn to listen to what your body needs.

There are also no foods that are considered off limits. However, thats not to say you should be eating whatever you want, when you want. The key is to know when youre actually hungry.

So, what should beginners keep in mind when getting started?

Dr. Albers recommends eating when youre hungry, recognizing when youre satisfied, and mindfully eating a wide range of nutritious foods.

Studies have shown that people who do intuitive eating have higher retention rates in regards to this way of eating than dieting, she said. They looked at people who started dieting and people who have done intuitive eating and they have found that they are able to sustain it for the long-term.

Intuitive eating is an approach everyone can use. However, you should speak with your physician first if you have certain medical issues, like diabetes or high blood pressure.

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The Benefits of Intuitive Eating vs. Dieting - Cleveland Clinic Newsroom

5 Things Our Registered Dietitian Would Never Do – Consumer Reports

Posted: August 9, 2022 at 2:11 am

Ideally, most of the foods in your cart shouldnt have complicated food labelsthink fruits, vegetables, and whole grains. But before I buy any new packaged food, I check out the nutrition and the ingredients list for hidden sugars, saturated fats, and other unhealthy ingredients.A.K.

If youre buying packaged foods, the side of the box, which lists the ingredients and the nutrients, is your best friend. Avoid relying on the boxs front, where companies may make unregulated health claims that can be misleading. Check the Nutrition Facts for foods that are low in saturated fat (but not necessarily other forms of fat, which are essential to a well-balanced diet), sodium, and sugar, and high in fiber and vitamins, such as vitamins A and D.

Adult women should get between 21 and 25 grams of fiber and a maximum of 24 grams of added sugars per day, while men should consume between 30 and 38 grams of fiber per day and no more than 36 grams of added sugars per day. All genders should cap their sodium intake at 2,300 mg of sodium per day.

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5 Things Our Registered Dietitian Would Never Do - Consumer Reports

Seven nutrition myths busted including why snacking isn’t bad for you – Fit and Well

Posted: August 9, 2022 at 2:11 am

Many people will have grown up hearing and believing various nutrition myths. From old wives tales to fad diets, its difficult to know what to believe when it comes to health and nutrition. This is particularly true when new research is often being undertaken and its not unusual for experts to change their mind about the best foods to eat for good health.

But there are some long standing myths about nutrition that simply arent true, even though lots of people might have believed them for a long time (and adjusted their diets accordingly as a result). One of the reasons is that a lot of people are looking for quick fixes when it comes to losing weight, gaining muscle or improving their overall health. But doing any one of these things is rarely simple and it often requires making a number of different changes to your diet, such as using the best protein protein powders for weight loss or supplementing where there are shortfalls in particular nutrients.

So what are some common beliefs we have about nutrition that are actually completely unfounded? We asked Sophie Medlin, a dietician at CityDieticians (opens in new tab), to debunk seven nutrition myths that you might have otherwise believed.

Youll often find gluten-free products in the health section of a supermarket, which might make you think theyre healthier alternatives to food items with gluten in, like pasta and bread. But actually, theres nothing wrong with eating gluten for most people.

Gluten causes no harm unless you have coeliac disease or an intolerance, Medlin says.

If you think you have a gluten intolerance, its best to speak to your doctor so you can take the relevant tests and opt for a gluten-free diet. However, for most of the population, gluten-free pastas and breads actually arent the best choice.

The vast majority of gluten free foods contain extra, fat, sugar, salt and other additives to make them taste better, meaning theyre worse for your health, Medlin explains.

(Image credit: Getty Images)

Fat is one of three macronutrients, alongside carbohydrate and protein, meaning its an essential part of a healthy, balanced diet. However, fat has been villainised over the years and many people consider all fatty foods unhealthy.

Yet there are actually a lot of healthy fats that you can find in foods like avocados, peanut butter and oily fish. Omega-3 foods are also part of a healthy diet.

According to Medlin, there are some cases when low-fat foods could be beneficial, like if you have high cholesterol. Often, whether or not a low-fat product is better for you will also vary on a case by case basis. For example, semi-skimmed milk is generally better than full cream, Medlin says. In general though, when the fat is taken out of a product, it is usually replaced by sugar or artificial ingredients, meaning you are less likely to benefit from the lower fat content.

Ever followed a diet that told you to cut out snacking completely? This could have inadvertently been working against you. Snacking can be a really useful way to regulate your appetite throughout the day and prevent overeating, Medlin says.

A 2014 study (opens in new tab) found that whether or not snacking is beneficial for your health will depend on a number of things including your age and your attitude towards snacking, suggesting: developing recommendations regarding snacking and meal frequency is extremely problematic for numerous reasons.

Its never healthy to feel hungry and low in energy and often snacking is the best solution for this, particularly if you have an active lifestyle. I have to add planned snacks to most of my patients' diets to ensure they dont graze all afternoon or eat too much in the evening, Medlin adds.

Try these high protein snacks to help keep you fuller for longer.

(Image credit: Getty Images)

Weve all heard the phrase that breakfast is the most important meal of the day. But is this really true?

We used to think that skipping breakfast was a bad idea but now we know that eating to your appetite is better, Medlin says. If you dont feel hungry first thing, wait until you are hungry but make sure this doesnt mean that youre so hungry at lunch time that you eat three times as much as you would if you had breakfast.

A 2014 study carried out over four months actually found that eating breakfast didnt have any significant impact on weight loss compared to not eating breakfast. So its a good idea to listen to your body when it comes to food; this might mean having five small meals in the day, rather than three big ones, or it might involve skipping certain meals, like breakfast, if you have no appetite. Its all about figuring out what works for you.

As well as fats, many people believe carbohydrates are inherently unhealthy and that we should minimise the amount of carbs we include in our diet. But actually, carbohydrates are in almost every food we eat and focussing solely on this one macronutrient might mean you neglect other areas of your diet.

Medlin explains that for most people, eating a low carb diet will induce weight loss. But this doesnt mean it is right for everyone because any calorie controlled diet will induce weight loss even if its 90% carbohydrate, she says.

There have been various studies undertaken on the effectiveness of low-carb diets, with a recent study (opens in new tab) finding that low-carb diets can be effective in the short term for weight loss but are not necessarily healthy in the long term.

Medlin stresses that its important to also think about how following a low-carb diet could affect your attitude towards nutrition: For some people, restricting carbs can mean that all they think about is carbs and then they end up bingeing on them so it really doesnt work for everyone.

(Image credit: Getty Images)

Most people would struggle to find anything enjoyable about a juice cleanse (i.e. fasting other than drinking a set number of juices for a certain time period). But many people try them in an attempt to lose weight or detox their body.

However, Medlin says that these types of cleanses are generally fruitless. Nothing can detox your body apart from your liver and your kidneys, she says. Juice diets actually put your kidneys under a lot of pressure with a number of people being hospitalised as a result.

Your liver and your kidneys need normal food to work optimally and juice diets restrict their ability to do their job properly and put them under additional pressure creating more toxins in the body rather than less.

And while juice cleanses might make you lose weight right away, a 2017 review (opens in new tab) found that they can actually lead to weight gain when you return to your regular diet.

Nutritional supplements have become increasingly popular in recent years, with 2021 data (opens in new tab) suggesting that 20 million people in the UK are taking supplements every day. Many people believe that taking daily vitamin and mineral supplements are an essential part of being healthy but this isnt necessarily true.

According to the NHS in the UK, most people do not need to take vitamin supplements and can get all the vitamins and minerals they need by eating a healthy, balanced diet. Plus, taking some supplements unnecessarily could be potentially dangerous, according to Medlin.

There is no one-size-fits-all when it comes to supplements and its really important to remember that supplements are not benign, she says. Vitamin and mineral supplements in particular can cause physical harm and potentially permanent health harm for people who have particular conditions or genetic traits.

This isnt to say that supplements are redundant they can be a really useful tool if youre lacking in specific vitamins or nutrients, especially if your doctor has recommended taking them to improve your health. But they are not an essential part of a healthy lifestyle for everyone.

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Seven nutrition myths busted including why snacking isn't bad for you - Fit and Well

The Lunch Box: A New Option for People on Special Diets Detroit Jewish News – The Jewish News

Posted: August 9, 2022 at 2:11 am

Inside her neat Oak Park home, Shirah Fish is layering lettuce, sliced avocado, broiled chicken and quinoa in the 20+ plastic containers spread along the kitchen counter. Soon customers will be picking up their lunches, and shell deliver the rest in the Oak Park/Southfield/Huntington Woods area.

People forget to take care of themselves. Moms are busy with their kids all day and lunch is the first thing they forget, Shirah said. Then there are people who work through lunch, especially if theyre working remotely.

Shes pleased to help with that. I prepare a healthy lunch for them. A healthy meal can keep them going, can prevent that sluggish feeling and gives them a good boost of energy.

Shirah keeps strictly kosher, although her enterprise is not under rabbinical supervision. She has always loved cooking, but the busy mom of six with a degree in behavioral psychology never thought it would be something she would do professionally. This job started by accident. In February, her friend Aliza Ancier shared her struggles finding drop-in childcare.

You probably wont find it, Shirah told her. I never found any either. What worked for me was to figure out the things I wanted to get done while my babies were in daycare and then pay someone to do those things.

Aliza shared she was too swamped to cook and wasnt eating healthy lunches.

You could totally pay someone to make you lunch, Shirah told her. Anyone would do that. I would.

Really? Aliza asked eagerly. Can you start Monday?

Shirah was taken aback. She hadnt meant it like that But after thinking about it, she figured she might as well try. It would probably be good for her, too!

Thats when Aliza mentioned she was gluten-free. Intimidated, Shirah reached out to her friend Samm Wunderlich for recipe ideas.

After offering some suggestions, Samm said, If youre already making lunches for Aliza, can you make some for me, too? Im gluten-free and vegan.

As Shirah prepared lunches for Aliza and Samm, she took pictures of the food and shared with her friends. Soon she was getting more requests. Things quickly snowballed and the week before Pesach, Shirahs newly named The Lunch Box was preparing almost 10 lunches every day.

As word spread, her happy customer branch grew and now Shirah is preparing about 100 lunches every week.

She also began preparing a Shabbat menu, which includes different kugels, gefilte fish, baba ghanoush and other dips, chicken soup and desserts. She recently even catered a bridal shower and has prepared platters for office lunches.

I tell my customers, whatever theyre interested in, just ask. If I can do it, Im happy to help, Shirah said. She began selling customized protein shakes after a customer requested it and has recently begun providing breakfast power bowls, which include steamed spinach and scrambled eggs on a base of rice and beans, with pico de gallo and guasacaca sauce.

Most of her clientele are people with some kind of special diet dairy free, allergies, gluten-free, vegan and there arent many kosher choices for them in Metro Detroit.

Out of all the kosher local restaurants, there are maybe two things I can order off the menu, Samm said, who is on a vegan, whole foods, plant-based diet. Shirah is filling a huge need. Its so convenient and shes been wonderful at accommodating my requests for modifications and has been very receptive of my feedback.

Samms favorites are Shirahs ethnic dishes. The lunches are great, but the best is when she makes an elaborate curry or urban tofu, something I wouldnt usually bother making myself.

Shirah creates a menu early in the week, with at least one type of Mexican bowl. So far, Ive never made the same thing twice, Shirah said. Shes always skimming magazines and cookbooks for new ideas and is discovering and using ingredients she never before knew existed.

Her daughter Lea, 15, works as her sous chef, but Shirah does the artistic presentation herself.

The best part is seeing people enjoying my food, said Shirah, who has received tremendously positive feedback. But the hardest part is that I dont actually taste my food. Its hard for me to gauge what will be popular because Im actually a really picky eater!

Lunches are a flat rate of $15 per day. Follow The Lunch Box on Instagram @thekosherlunchbox or on Facebook. For the weekly menu or more information, call, text or WhatsApp Shirah at (248) 607-4549.

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The Lunch Box: A New Option for People on Special Diets Detroit Jewish News - The Jewish News

A Harvard nutritionist shares the No. 1 vitamin that keeps her brain ‘young and healthy’and foods she eats ‘every day’ – CNBC

Posted: August 9, 2022 at 2:11 am

As a nutritional psychiatrist, I always make it a point to maintain a well-balanced diet. Much of that has to do with making sure I get all the right vitamins, especially because it's essential to preventing cognitive decline.

And given that the risk of neurological diseases increases as we get older, one question I often get from my patients is: "What is the best vitamin for protecting our aging brains?"

Each of our microbiomes is like a thumbprint, so a truly effective eating plan is personalized to the unique needs of an individual. But the vitamin group I prioritize the most to keep my brain young and healthy are B vitamins.

Depression, dementia and mental impairment are often associated with a deficiency of B vitamins, a study from the Wayne State University School of Medicine found.

"A B12 vitamin deficiency as a cause of cognitive issues is more common than we think, especially among the elderly who live alone and don't eat properly," says Rajaprabhakaran Rajarethinam, a psychiatrist and the lead author of the study.

There are eight different B vitamins, each with its own primary health benefits:

Vitamin B1, or thiamin, is crucial for the basic function of our cells and the metabolism of nutrients for energy.

The brain is one of the most metabolically active organs in your body, which means it needs the support of thiamin to prevent the deficiencies that can lead to neurological problems down the line.

Vitamin B2, or riboflavin, acts as an assistant to enzymes in our cells that carry out important reactions, such as in the body and brain.

It also helps to grow cells, produce energy and break down fats and external materials like medications.

Vitamin B3, or niacin, works with more than 400 enzymes to produce materials like cholesterol and fat needed within the body, and to convert energy for all our organ systems. Niacin is also an antioxidant, which helps reduce excess inflammation.

Vitamin B5, or pantothenic acid, is essential for making a molecular compound called coenzyme A, which helps our body's enzymes build and break down fatty acids for energy.

It also helps our cells generate acyl carrier proteins, helping to produce necessary fats. The brain is primarily fat, so pantothenic acid is among the most important vitamins in supporting brain health.

Vitamin B6, or pyridoxine, is notable for its role in disease prevention because proper levels of this vitamin is associated with lower risk of a number of cancers.

Additionally, pyridoxine helps many chemical reactions in the body that support immune function and brain health.

Vitamin B7, most commonly known as biotin, regulates cell signals for quick and efficient communication throughout the body. In the brain, it's crucial for cellular signaling via neurotransmitters.

Vitamin B9, or folate, is a popular supplement and a key vitamin for supporting brain and neurological health, optimal neurotransmitter function, and balanced psychological health.

Another benefit is that it helps encourage cellular detoxification.

Vitamin B12, or cobalamin, is an essential vitamin for forming red blood cells and DNA, and supporting the development and function of the nervous system.

B12 also supports the breakdown of homocysteine, a protein that can negatively impact cardiovascular health and lead to dementia when in excess.

I'm a "food-first" person, so I always encourage people to incorporate foods containing these vitamins into their meals. However, our diets are not perfect, so there may be instances where supplements may help. If that's the, case my simple advice is to "test, not guess" and consult with your doctor first.

The goods news is that B vitamins are among the easiest to work into your diet because foods that are rich in one B vitamin often contain many, if not all, of the B vitamins when consumed as whole foods.

Here are six vitamin B-rich foods I eat every day:

1. One egg contains a third of the recommended daily value of vitamin B7, while also containing small amounts of many of the other B vitamins.

2. Yogurt is high in both vitamin B2 and vitamin B12, as well as in natural probiotics, which support both gut health and mental health.I like plain Greek yogurt for the added protein.

3. Legumes such as black beans, chickpeas, edamame and lentils all help to boost your mood and brain health. They are an excellent source of vitamin B9, and include small amounts of vitamin B1, vitamin B2, vitamin B3, vitamin B5 and vitamin B6.

4. Salmon is naturally rich in all of the B vitamins, especially vitamin B2, vitamin B3, vitamin B6 and vitamin B12. Be mindful of the source of your seafood, and remember that frozen or canned salmon is a budget-friendly option, too.

5. Sunflower seeds are one of the best plant sources of vitamin B5. You can get 20% of the recommended daily value of this vitamin from just one ounce of seeds!

6. Leafy greens such as spinach, Swiss chard and cabbage are a great source of vitamin B9. This is the first food I suggest to patients who want to boost low mood.

Dr. Uma Naidoois a nutritional psychiatrist, brain expert, and faculty member atHarvard Medical School. She is also the Director of Nutritional & Lifestyle Psychiatry at Massachusetts General Hospital and author of the best-selling book"This Is Your Brain on Food: An Indispensable Guide to the Surprising Foods that Fight Depression, Anxiety, PTSD, OCD, ADHD, and More."Follow her onTwitterandInstagram.

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A Harvard nutritionist shares the No. 1 vitamin that keeps her brain 'young and healthy'and foods she eats 'every day' - CNBC

HALL THINGS CONSIDERED: Why lifestyle changes are better than diets – Times Tribune of Corbin

Posted: August 9, 2022 at 2:11 am

Since my weight is the heaviest its ever been, and since that number just continues to grow, I want to start the month of August by trying to at least watch what I eat.

I hope to squeeze in some exercise as well in order to help my weight loss and help me get in better shape, but I feel like my food intake is certainly something I can control better than I have been doing.

Right off the bat, some changes I can make include cutting out soda pop, limiting how much kiddie cereal I eat for breakfast (and sometimes as a late-night snack), and packing healthy food to work that I can eat instead of relying on our vending machines or local fast food restaurants.

Those all sound simple enough but I love having something flavored to drink with dinner, Im addicted to sugary cereal, and I cant help but to snack all night long when Im here at the office.

But I think if I can find some substitutions or at least cut back a little, that will certainly help a lot.

Of course they say that diets dont really work and instead you need to make a lifestyle change.

This means that you cant just say for a few months youre going to watch what you eat, and then afterwards fall back to your old routines.

You have to find what works best for you and then make permanent changes for the better.

Trying out a fad diet or making crazy sacrifices for 30 days will ultimately just burn you out and put you right back where you started.

I certainly agree with that way of thinking and hopefully I can make some permanent changes over the next few weeks and months.

When we are backslidden in our relationship with God, or if we dont have a relationship at all, we also need to make changes that are permanent.

Too often we just find ourselves attending church for special occasions, but sleep in the rest of the year. Or we force ourselves to get through a weeklong Bible study only to never look at the Bible ever again.

We also have to choose to be all in with all aspects of our lives as well.

Devoting an hour a week to God while spending the rest of the week living a life of sin is certainly not enough.

Its great if youre involved in church but you need to live according to Gods will the rest of the time also.

Otherwise, youre simply using church as a country club or as a way to put on a phony face for your peers.

Romans 12:1 says, I beseech you therefore, brethren, by the mercies of God, that ye present your bodies a living sacrifice, holy, acceptable unto God, which is your reasonable service.

Just like with our eating habits, we have to make complete lifestyle changes for God that are permanent.

If we only make little changes here and there, or if we just do a nice activity here and there, well ultimately end up right back where we started.

We have to think about how God wants us to live all of the time and not just some of the time.

Only then will we be truly sold out to the Lord and ready to take on the world.

Brad Hall is the nighttime editor at the Times-Tribune. He can be contacted at bhall@thetimestribune.com.

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HALL THINGS CONSIDERED: Why lifestyle changes are better than diets - Times Tribune of Corbin

Gay nutritionist shares tips on how to bottom without douching – PinkNews

Posted: August 9, 2022 at 2:11 am

Daniel O'Shaughnessy says douching isn't always necessary. (PinkNews)

Daniel OShaughnessy had worked as a nutritionist for years before he thought of writing a book specifically about queer peoples nutritional needs.

The idea first came to him when he was dragged onto a gay cruise ship.Throughout his career, Daniel had worked extensively with LGBTQ+ clients people had come to him because he, as a gay man, seemed like a safe space, like somebody who understood their needs better than a straight nutritionist could.

On that cruise ship, people kept asking Daniel for tips on what foods would help them bounce back from a wild weekend.

I thought, Why is there no resource anywhere for the LGBTQ+ community?' Daniel says. Not everyone can afford a nutritionist what if the information was just in a book?

The result isNaked Nutrition: An LGBTQ+ Guide to Diet and Lifestyle. It caters to people all across the LGBTQ+ spectrum, with chapters on nutrition for people with HIV to the specific dietary requirements a trans person undergoing medical transition might need to be aware of.

There are other topics too theres a section that deals with nutrition for bottoms (spoiler alert: you really dont need to be douching very often, if at all), while the book also offers some tips for a fast recovery if you like going clubbing at the weekends.

At the core of the book is the idea that nutrition is so much more than the simplistic (and somewhat harmful) model of calories in, calories out that so many people cling to. Daniel is careful to note thatNaked Nutritionis not a diet book.

Thats the big difference between dieting and nutrition, Daniel explains. Nutrition is fuelling the body, giving your body what it needs to thrive. I practice something called functional medicine it looks at the body as a whole. For example, if you have a digestive issue, youre looking to find the root cause of it.

He says calories can be important for some people, but theyre not everything.

Particularly with weight loss for example, or even muscle gain, yes, they play a role, but they dont take into account the person and the trauma the person has.

You need to have a very 360 view of your health and when you just look at calories, its a very, very tiny bit of someones health. You can drink 2,000 cans of Diet Coke a day and be within your calorie allowance is that healthy?

He warns people away from fad diets, which are usually sold as a quick fix or as a way of controlling something else, Daniel says.

I would say one issue is, why do you need to control something? Unpick control maybe you cant control something else in your life, he says. Fad diets are a plaster on the main issue. Essentially what Im aiming to do is to give someone a whole health approach and say, You cant do a fad diet forever. Its pretty impossible. Yes, they work most diets work if you stick to them but the sticking to them is the problem.

He urges LGBTQ+ people who are in a cycle of fad diets, or who are thinking of going on one, to look inward and to reflect before they try to make drastic changes to their lifestyle.

It ties in to the self-love thing. Many LGBTQ+ people have self-love issues because weve always been told were not good enough. We have a lot of rejection trauma. So thats quite important for me to just unpick why you want to diet.

Naked Nutritionisnt all about calories and nutrition either the book also touches on muscle gain and fitness. If youve spent any time in gay spaces, youll know how much emphasis is placed on a muscled physique. Daniel says people who want to bulk up should first of all question why they want to do so in the first place.

Is it for yourself or is it about looking for external validation? Daniel asks.

If your motivations are coming from a good place, fitness and muscle-gain can be a healthy and rewarding journey to embark on. Still, Daniel knows that many LGBTQ+ people will have had negative experiences in the past that might make them nervous about the idea of going to a gym.

You dont need to go to these fancy gyms, you can do lots of workouts at home and there are plenty of free workouts online, he says. Pick and choose what you want to do.

He takes a non-judgemental approach to anabolic steroids in his book he instead provides readers with the information they need on side-effects.

I always say, heres the information Im not going to tell you what to do. Theres a lot of side-effects to taking anabolic steroids, theyre not a quick fix, and the minute you take them you have side-effects you probably wish you didnt have. Ive had personal experience of taking anabolic steroids and I could not sleep. I was so anxious. Was that worth it for me? No, so I dont see the point in taking them, and they can become very addictive in themselves.

Naked Nutritionalso touches on some of the more practical, day-to-day issues queer people might want tips on. One of those is bottoming.

If youre a regular bottom, the chances are that you put a lot of work into it. Douching is one of the most common ways to ensure the passageway is clear and clean before sex but Daniel is firmly of the belief that the right diet could eliminate the need for douching entirely.

Chances are, we shouldnt really need to lets put it that way but there are times we might have to, Daniel says. Every gay man has had an accident somewhere along the line, and you just have to realise that we are having sex somewhere where pieces come out of us, so accidents do happen.

However, the biological reality is that we should be ready for sex at most times because of the way the colon is constructed, Daniel explains.

Thats because we should be able to have complete and healthy bowel movements in the time we have them. But there are things that get in the way of that, whether its digestive concerns, stress, what we eat, what we drink all of these may impact the structure of our faeces, so that may then change our bowel habits and whether we feel completely clean.

If youre eating a healthy diet with plenty of fibre, the likelihood is that youll be clean and ready to rumble, Daniel says the problem is the psychological element. People get anxious about the possibility of having an accident, so they douche as a preventative measure.

If youre a person that douches, youll probably want to douche, so its about douching well.

It ruins sex it gets in the way of sex, you panic, you dont relax, so in those moments you might think, Im going to douche. There are people who think douching is very unhealthy for us, but if youre having prolonged sex, or you just want to make sure youre clean, then it might be better to do that than to not do that.

However, Daniel does make the point that there is such a thing as too much douching. Going overboard can wipe out beneficial bacterias in your gut.

That can impact risk of STIs and is bad for our health as well, Daniel says. Its about weighing it up ultimately if youre a person that douches, youll probably want to douche, so its about douching well.

If you do want to move away from douching, Daniel recommends people take a look into the loo to get an idea of where the problem might lie.

Look at your food triggers, he says. Theres something called the Bristol Stool Chart and your stool should look like the healthy stool on that. If it doesnt then you have to look into why and figure out how to get a healthy stool.

There are, of course, some quick hits for bottoms if they dont want to deprive themselves of their favourite foods. The market is flooded with supplements for queer men Daniel recommends Psyllium Husk, which is a plant-derived source of fibre.

Just be mindful not to take that with any medication because it might pull that with it because its actually a soluble fibre, he says. People can also try eating fermented foods like yoghurt, kefir, kimchi and sauerkraut to help with their beneficial bacteria.

The book is a first step to taking responsibility for self-love.

Theres a lot inNaked Nutrition, but at the end of the day, Daniels most important piece of advice is that people dont overload themselves while trying to make changes.He wants people to know its possible to do a couple of small things differently if they want to improve their health and wellbeing they dont need to radically transform how they eat.

The book is a first step to taking responsibility for self-love. I want to encourage you to step up, read the book, take what you want from it. It doesnt have to be such a hard life.

Naked Nutrition: An LGBTQ+ Guide to Diet and Lifestyle is out now.Daniel OShaughnessys Instagram is here.

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Gay nutritionist shares tips on how to bottom without douching - PinkNews


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