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Consuming alcohol, poor diet linked to liver cancer –

Posted: June 7, 2020 at 12:47 am

By Yang Yuan-chi and Lo Chi / Staff reporters

About 20 percent of Taiwanese with liver cancer also have a diagnosis of fatty liver disease or alcoholic liver disease, Taiwan Cancer Registry data showed.

One in four people worldwide have fatty liver disease, while the incidence rate in Taiwan ranges between 11.4 percent and 41 percent, reports released by the National Health Research Institutes showed.

The main causes of fatty liver disease are high cholesterol and ineffective diabetes self-management, which are often related to being overweight and drinking too much alcohol.

The WHO defines being overweight as a chronic condition, and people who are overweight for a long period are more likely to be diagnosed with fatty liver disease and to experience diabetes, high cholesterol, hypertension, cardiovascular disease, gout and osteoarthritis and at almost twice the frequency of those with a healthy weight, Health Promotion Administration Cancer Prevention and Control Division Director Lin Li-ju () said on Friday.

Fatty liver disease results when excess fat causes inflammation in the liver, said Hsu Shu-ting (), a doctor in the Gastroenterology and Hepatology Section of Cathay General Hospital in Taipei.

Although it does not sound like a serious condition, persistent inflammation increases a persons chance of developing cirrhosis or liver cancer by 10 to 20 percent, so it should not be ignored, she said.

People living a modern lifestyle are busy at work and lack exercise. They often eat out and take sugary drinks with their meals, which significantly increases their likelihood of developing liver cancer, Hsu said.

Drinking too much alcohol will likely lead to alcoholic liver disease, which puts people at a higher risk for cirrhosis and liver cancer at a much greater incidence rate than those with fatty liver disease, she said.

A fatty liver does not have obvious signs those with a fatty liver who experience pain or fatigue might already have severe inflammation or a tumor so regular medical examinations are needed, she added.

Most people should have an annual checkup, but someone with advanced fatty liver disease and severe inflammation should go every six months, Hsu said.

No drugs effectively treat fatty liver disease, Lin said.

Those with the condition should engage in at least 150 minutes of physical activity per week, she said, adding that aerobic exercise has been shown to reduce the fat level in the liver.

It is important to have a balanced diet to eat more fruits, vegetables, and whole grain and multigrain foods, while avoiding sweets, refined foods, foods high in salt and oil, and processed foods, Lin said, adding that a fatty liver and fibrosis of the liver greatly improve from a 5 to 10 percent reduction in body weight.

In 2017, 11,225 people in Taiwan were diagnosed with liver cancer and 8,402 people died of it, the Health Promotion Administration said, adding that by preventing or treating a fatty liver, people can effectively reduce their risk of liver cancer.

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Consuming alcohol, poor diet linked to liver cancer -

Forum, June 6: America is reaping what it has sown – Valley News

Posted: June 7, 2020 at 12:47 am

Published: 6/5/2020 10:00:22 PM

Modified: 6/5/2020 10:00:10 PM

Dr. Martin Luther King Jr. said a riot is the language of the unheard. While not condoning violence, much less encouraging it, I am compelled to observe that the sometimes-violent methods recently adopted by protestors seeking redress of long-festering social issues is, sadly, understandable. When a match is tossed into a pile of dry brush, the result is as predictable as it is tragic.

The unrest seen in many parts of our nation this past week following yet another egregious policing overreach that caused the death of a fellow citizen, a black American, is not, in my view, an overreaction.

This unrest rises from a deep foundation: more than four centuries of exclusion, injustice, emotional abuse, lack of basic human decency, and yes violence systematically perpetrated by our establishment institutions and, via our votes, by ourselves upon our fellow American citizens of differing genetic lineage.

Violence begets violence; mistreatment begets mistrust. Slavery. The lack of any meaningful economic justice post-slavery. Lynching. Jim Crow. The unrealized promise of the 13th, 14th and 15th Amendments. Separate but equal. Systemic racism. Mass incarceration. Wage inequality. Opportunity inequity. Rising from all of these, black Americans to this day have a palpable fear of being found suspect based only on the color of their skin, a fear I can never know.

Whatever the recent violence, it falls far short of the cumulative scale of these past sins, sins so long unaddressed as to embed them in the American soul. We reap what we sow, and weve been sowing a crop of racism in this nation for a very long time.

Therefore, the noteworthy news is not the violence but rather, in the face of the past, the praiseworthy restraint exhibited by the vast majority of protestors.

MARK KIRK

Unity

Rising to meat demand (May 24) is another Valley News article fostering animal cruelty. The demand for animal flesh, secretions and dead embryos is a false demand there are no nutritional needs to eat animals and therefore no ethical reasons exist to force-breed and kill animals for consumption. And Vermont Packinghouses claim of humane slaughter is a joke. Unnecessary killing is not humane.

Animal-free diets are not fads; they are the only ones humans can afford if we want a future. Popular Mechanics reported that plant-based diets are healthiest for humans, the planet and animals. The World Health Organization categorizes processed meat as a carcinogen. A number of studies have suggested that dairy products are a risk factor for prostate cancer. These science-based truths are what our family, including the dogs, live by without problems.

Kaiser Permanente, the largest health care management company in the U.S., has a 36-page ebooklet about the advantages of plant diets. Humana, the third-largest insurance company, trains doctors in plant-based health. The U.N. urges everyone to eat plant-based diets as the surest and least destructive way to slow global warming and to end hunger and starvation because 80% of farmland grows monocrops for farmed animals, croplands that in the U.S. alone could feed 800 million people. Worldwide, farmlands could produce ample food to feed all humanity healthful plant-based meals, and reduce the greenhouse gases from the farmed animal industry that drive global warming, and dramatically reduce the poisoning of the land, water and life with runoff from farming animals fed antibiotics and ground up garbage. And it would end the slaughter of 3 trillion animals annually for human food.

Why does the Valley News promote animal-based foods and print articles about slaughterhouses, for example, as if they are necessary? Why take the corporate oppressors side with language like stunning unruly animals instead of writing animals struggling for their lives? To not tell the whole story with compassion is lazy reporting.

MARGARET D. HURLEY

Claremont

My name is Keith Stern and I am announcing my campaign for a Windsor County Senate seat.

Some of you may recognize me as a candidate for governor two years ago. My platform has not changed. I want to see a more responsible budget, end Act 46, and make sure Act 250 goes back to its original goal and not become an excessively restrictive hurdle to responsible development. Above anything, the federal and state constitutions must be followed to avoid an abusive government.

Humorist Dave Barry once said that Democrats are good people with good intentions but are incompetent. They would stop to help someone change a tire and end up setting the car on fire. They have good intentions but they fail to understand how to accomplish their goals, so they end up hurting us with ineffective and restrictive laws. We can see this every day with struggling businesses, low wages and an overall cost of living that exceeds our wages. Affordable housing is a major issue here because of excessive regulations for building, high property taxes, and lack of landlord protection against destructive, disruptive and deadbeat tenants. Ultimately, it isnt the landlords who bear the cost, it is the tenants. I will work to fix these issues to create more affordable housing. At the same time, I will introduce an effective tenant protection bill as well.

The cost of health insurance is very high in comparison to other states, again due to overregulation. I will introduce a bill that will lower health care and health insurance costs.

I hope you visit my Facebook page, Keith Stern for Windsor County, and see how a vote for me will be a vote for lowering taxes, a better, more cost-effective education system, and a stronger economy.

KEITH STERN

North Springfield

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Forum, June 6: America is reaping what it has sown - Valley News

Two women reveal how Weight Watchers alone helped them lose 7st between them – The Sun

Posted: June 7, 2020 at 12:47 am

WW - formerly known as Weight Watchers - has been helping people shed the pounds for years thanks to its easy points-based system and weekly workshops.

Two women who have first-hand experience of the popular diet are Natasha Summar Allen and Louise Eccleston, who have shed an impressive 7st between them.

NATASHA Summar Allen, 33, is a stay-at-home mum and vlogger, and lives in Stalybridge with husband Andrew, 44, an administrator, and children Harrison, 10, and Layla, seven.

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Natasha says: Looking at myself in the mirror, I was close to tears. The size-16 top I was wearing was too small and had ridden up over my tummy like a crop top.

I hated what I saw, but I was so used to food being my comfort that changing my ways was terrifying.

Growing up in Manchester, I was always a size 6-8, at 5ft 7in, despite regularly tucking into my mums big portions of Middle Eastern kebabs, casseroles and biryanis.

I met my husband Andrew in June 2006 when I was 19 and studying law at Staffordshire University.

I was a size 8-10 when we met, but over the course of the next year I began to slowly put on weight as we shared takeaways together on the sofa.

I always hated the gym, so was very inactive, and my weight crept up to a size 14 by October 2007. I never felt full, and sometimes after dinner wed go to a McDonalds Drive-Thru where Id polish off three double cheeseburgers.

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I knew I was putting on weight, as I started having to buy size-18 clothes, but Andrew reassured me that I looked great.

I had our son Harrison in February 2010, followed by daughter Layla in January 2013, and actually lost weight during both my pregnancies, going down to a size 12, as I suffered with hyperemesis gravidarum (severe vomiting) and was hospitalised as I couldnt keep food down.

But after both babies, I comfort ate as I felt constantly tired, ballooning to a size 16. With two young kids, I was so busy that I didnt have time to cook for the whole family, so I began to rely on ready meals and freezer food.

It was when I finally weighed myself in June 2018 that I knew something had to change. I was 12st 2lb and a size 16-18, and when I looked in the mirror I felt unattractive and frumpy.

Although I knew Andrew loved me and was attracted to me, Id often complain to him that I hated how I looked, and it really affected my confidence.

My sister Zeinah, 35, had lost 8st on WW, going from a size 28 to a 14, so I decided to try it out for myself. I signed up online, and started using the recipe builder to make meals from scratch.

6

Natasha's meals...

THEN

Breakfast: Full English with bacon, sausages and toast

Lunch: Big bowl of pasta with sauce and garlic bread

Dinner: Curry with rice and naan

Snacks: Sandwich, McDonalds, toast, sweets and cake

NOW

Breakfast: Fruit and yoghurt or porridge

Lunch: Warm chicken salad or butternut squash soup with home-made bread

Dinner: Home-made burger or curry

Snacks: Fruit

Id not cooked much in the past, but I loved making burgers, soups, or chicken and rice. Snacks would be fruit or home-made cake. I didnt drink much alcohol anyway, but I cut it out completely.

The changes felt small, but they soon stacked up, and in the first week, I lost 4lb. Over the next year, I steadily lost between 2-3lb per week.

I didnt exercise, but as a mum of two, I definitely burned off extra calories running around after the kids. When I hit my goal weight of 10st 5lb in June 2019, I was over the moon.

At a dress size 10, I could buy whatever I wanted from Topshop, and Andrew noticed a huge change in my confidence. I felt so much sexier and more attractive around him, plus I had more energy to play with the kids.

The changes felt small, but they soon stacked up, and in the first week, I lost 4lb.

I found losing weight on the plan so easy that I changed my target, and now Im a dress size 6-8 and 8st 2lb a total loss of 4st.

These days I still follow a lot of WW recipes. Ive also been posting videos on my YouTube channel of my WW meals, and theyre really taking off my food is even being featured in a new Asda advert!

LOUISE Eccleston, 30, is an events performance manager for a hotel group and lives in Richmond with fianc Michael, 32, a kitchen designer.

6

Louise says: Standing at check-in, I burst into tears of embarrassment. A member of airline staff had just asked if I was pregnant.

I wasnt, Id just put on weight. It was the final straw it was time for me to get back in shape.

As a teenager, I kept my weight down with regular dance classes, and was always around a size 10 and 9st.

When youre younger, you eat what you want without thinking about it, but looking back my diet wasnt very healthy I always loved fast food and big roast dinners.

I met my fianc Michael on a dating app in April 2014 when I was 24 and working as an events manager. Straight away we got into the habit of eating a lot together.

We had a favourite Indian takeaway and Id order a korma and garlic naan. If we were meeting friends for dinner, wed drink loads of wine and finish off with cheese.

6

Working in the hotel industry, I stay overnight at our hotels several times a month, and would always try out the restaurants, ordering steak and chips washed down with wine and a big chocolate dessert.

I never weighed myself, but over the next four years I gradually got bigger.

By the time we went on an all-inclusive holiday to Turkey in April 2018, at 5ft 7in I was a size 14 and felt self-conscious by the pool, constantly wearing a sarong.

When youre younger, you eat what you want without thinking about it, but looking back my diet wasnt very healthy.

But it didnt stop me demolishing pizza and chips and drinking sugary cocktails at night. It was when we flew home that one of the airline staff asked if I was pregnant.

Id had an amazing holiday, but it was suddenly ruined. When I got home, I stepped on to the scales and was shocked to see I weighed 12st 11lb.

Id heard of WW, and signed up with the goal of losing 3st. I did some meal planning, and shopped using the apps barcode scanner to see how many points were in food.

6

Louise's meals...

THEN

Breakfast: Bowl of cereal

Lunch: Ham and cheese baguette, crisps

Dinner: Beef burger with sweet potato fries

Snacks: Chocolate bar

NOW

Breakfast: Wholegrain toast, avocado and poached egg

Lunch: Tuna with green salad and grains

Dinner: Paprika chicken with lentils, couscous and green beans

Snacks: WW wafer biscuit and grapes

Breakfast became poached eggs and wholegrain toast, and lunch was salad. I began cooking dishes such as paprika chicken, which came in at zero points, and lasagne made with butternut squash pasta, which is lower in carbs than regular pasta.

Im not a fan of the gym, but I walked more, which made a huge difference.

The weekly WW workshops were a bit scary at first, but everyone was so friendly. I lost 1st in the first six weeks and was able to fit into a size 12, which spurred me on to lose more.

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By December 2018, Id lost 3st and was back to a size 10. Michael said I looked great but, that best of all, I seemed happy again.

We went back to Turkey in April 2019, staying in a hotel with healthy meal options, and I felt confident in my bikini.

Im maintaining my weight as a gold member and still cook WW recipes, as they couldnt be easier and they taste delicious.

GOT a story? RING The Sun on 0207 782 4104 or WHATSAPP on 07423720250 or EMAILexclusive@the-sun.co.uk

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Two women reveal how Weight Watchers alone helped them lose 7st between them - The Sun

The Queen is not a foodie and follows a no-carb diet when eating on her own, former chef reveals – The Sun

Posted: June 7, 2020 at 12:47 am

SHE may have access to some of the world's top chefs - but it turns out, The Queen isn't too fussed by fine dining.

According to Her Majesty's former chef Darren McGrady, The Queen is not what you'd consider a "foodie" - unlike her husband Prince Philip.

2

Speaking to The Telegraph, the chef said: "[The Queen] not a foodie.

"She eats to live, unlike Prince Philip who loves to eat and would stand and talk food all day."

What's more, Darren claims Her Majesty follows a strict no-carb diet when she's eating on her own.

He added: When she dines on her own, shes very disciplined. No starch is the rule."

2

The monarchs meals are healthy, low-carb affairs, usually grilled fish or chicken with two different vegetables or a big bowl of salad.

That said, The Queen still likes to treat herself to something sweet from time-to-time - and Darren claims she's a total "chocaholic".

He told HELLO!: "She is absolutely a chocoholic. Anything we put on the menu that had chocolate on, she would choose, especially chocolate perfection pie.

But, the Queen won't entertain any old chocolate - in fact, it has to be dark.

"She likes chocolate, but only dark chocolate, the darker the better," he added. Shes not a big fan of milk or white chocolate.

While it's no surprise that the Queen is partial to a little chocolate, Her Maj's former pilot has claimed that the Queen wouldenjoy a tinned Fray Bentos pie on long-haul flightsin the 90s.

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In more Royal Family news, The Queen developed a good left hook when she was young after having fights with Princess Margaret, a royal expert claimed.

And Meghan Markle has been secretly working with animal charity as it battles funding crisis during coronavirus lockdown.

Plus Princess Diana used to take Prince William and Prince Harry on secret trips to McDonalds for Happy Meal toys.

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The Queen is not a foodie and follows a no-carb diet when eating on her own, former chef reveals - The Sun

10 Best Flour Substitutes – Healthy Alternative Flours – GoodHousekeeping.com

Posted: June 6, 2020 at 2:53 am

Courtesy of BrandsGetty Images

When it comes to baking, all-purpose flour is the tried-and-true backbone of many beloved treats. But all-purpose flour can, in fact, be swapped in whole or in part if you don't have any and can't get your hands on some. You also don't have to say goodbye to delicious baked goods just because you have an intolerance to gluten or are trying your hand at a new diet. In fact, there are a plethora of all-purpose flour substitutes that might actually provide a supercharged health edge to one of your favorite recipes.

"White refined flour is really limited when it comes to nutrition, as it contains practically no fiber or protein, says Good Housekeeping Institute Registered Dietitian Stefani Sassos, MS, RDN, a registered dietitian within the Good Housekeeping Institute. "Since its a concentrated source of refined carbohydrates, it can also spike blood sugar levels. Trying out alternative flours in your baking at home is a great way to create more well-balanced meals and add more nutrients to your diet.

Because theyre all derived from different grains, cereals, dried beans, and nuts, alternative flours vary greatly in taste, texture and nutritional value. Its important to understand their different flavors and textures to make the best possible substitutions in the midst of your next baking adventure. You'll also need to keep in mind that alt flours aren't always grain free if you have a gluten allergy, make sure to double check the label before purchasing a new flour for your pantry.

There's no denying that it's hard to keep up with all the new options in the baking aisle these days. Here are the easiest ways to make use of alternative flours in your kitchen, including some of Sassos' best picks to add to your shopping list.

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1Whole Wheat Flour

$18.13

Whereas all-purpose flour strips the wheat kernel of its bran (itsexterior) and germ (its inner seed), whole wheat flour is processed with the entire kernel. This contributes to whole wheat flours higher protein content than all-purpose, in addition to more fiber and other nutrients. When it comes to flavor, it is much wheatier (as the name implies!)and has a slightly nutty aftertaste. You can usually substitute up to 50% of all-purpose flour in any given recipe with whole wheat. Because this flour is derived from the same product that all-purpose flour is derived from, it tastes and behaves most similarly out of all the alternative flours to all-purpose.

2Quinoa Flour

$16.49

"Quinoa flour is really versatile, especially high in fiber, and is also a source of complete protein, which means it contains all of the essential amino acids," Sassos says. In a pinch, you can actually make quinoa flour at home from scratch: "Gently toast quinoa on a clean skillet, then add to a food processor or blender, and blend until it reaches a flour consistency. Sift it and allow it to cool before use."

While quinoa flour won't function well in yeasted breads, Sassos says she frequently swaps it in for regular flour in cookies, muffins, cakes, and loaves.

RELATED: 21 HealthyMuffin Recipes That Are Just As Delicious as Cupcakes

3Oat Flour

$16.89

As long as the oatsare derived from supplies processed in a gluten-free facility, then oatflour will also be gluten-free.It's mild, nutty flavor makes it a great options for pancakes, waffles, bars, and breads. You can also make it at home in a pinch:"Simply add oats to a food processor or blender and blend by itself until it reaches a flour-like consistency," Sassos says. "Oat flour has a nutty flavor and adds texture to baked goods, so I like it best as a flour swap in pancakes, muffins, or banana bread."

It's also one of the healthiest additions on this list:Oats contain soluble fiber that can help reduce bad cholesterol levels, won't impact blood sugar levels on its own, and aids digestive health.Swapping flour for this supercharged option can effortlessly make most any baked good that much better for you.

RELATED: Is Oatmeal Healthy? Everything YouNeed to Know

4Almond Flour

$7.99

Hello, low-carb baked goods! "If you're looking to cut carbs in your baked goods, I like almond flour because it performs really well in baking," Sassos says. "It's also a good source of Vitamin E, which is a fat-soluble vitamin and antioxidant that helps protect cells from damage and can even help fight off infection. Almond flour is also compliant with a lot of different diets, including low-carb, paleo, and gluten-free."

5Brown Rice Flour

$17.13

Brown rice flour is a greatgluten-free and high-fiber flour substitution. It functions well in place of flour intempura batters, pancakes, crepes, muffins and quick breads. Rice flours have a tendency to be a little gritty, so make sure that youre buying flours that are finely ground, or make them at home. Because its derived from brown rice, it will have a toasty, slightly nutty flavor.

RELATED: 25 Amazing Machine-Friendly Bread Recipes That Make Baking a Breeze

6Coconut Flour

$5.49

Want to impart that signature, tropical profile of coconut-y bliss into your baked goods? Try coconut flour. Its derived from dried coconut meat, making it powder-like, naturally grain-free, and ultra fine. Its an ideal 1:1 substitution for cookies, bars, muffins, and cakes. If you are following a Keto diet or thinking about Paleo, coconut flour is a superior, low-carb, gluten-free alternative flour. Make sure to add plenty of moisture to whatever youre baking when using coconut flour because its so high in fiber, it needs extra moisture to hold a baked good together.

7Chickpea Flour

$14.69

8Spelt Flour

$8.65

Spelt is a distinct type of wheat which means that this is a glutinous product. It cannot be fully substituted for all-purpose flour in baking, but it's addition makes for a robust flavor you'll be hard-pressed to find in most supermarket buys. Stick to a ratio of 3:1 all-purpose to spelt for the best results.Not only is it higher in fiber and whole grains, but it possesses a deep, nutty flavor thats delicious in cookies, cakes, breads, and muffins. Try it in your next batch of chocolate chip cookies youll be impressed by its toasty, rich flavor.

RELATED: Our Most Delicious Vegan Chocolate ChipCookies

9Buckwheat Flour

$14.99

Dont let the name fool you! Buckwheat flour possesses zero wheat byproduct, making it naturally gluten free. Buckwheat kernels are a pseudocereal (something that is not a cereal grain, like wheat or oats) that are harvested and ground into a dark brown, ultra-rich flour. Buckwheat flour is ideal for muffins, breads, and cookies; if you turn them into noodles, youve made soba noodles! This flour is a one-to-one substitution with all purpose four.

10Amaranth Flour

$5.99

Amaranth is an ancient grain that can be ground finely for a light, gluten free flour. Similar to buckwheat, amaranth is also a pseudocereal. It has a super nutty, earthy flavor thats tasty in cakes, scones, and breads. Because of its ultra fine texture, substitute it for about 25% of the wheat flour in your recipe.

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COVID-19 Impact and Recovery Analysis- Keto Diet Market 2020-2024 | Increasing Availability of Keto Products to Boost Growth | Technavio – Business…

Posted: June 6, 2020 at 2:53 am

LONDON--(BUSINESS WIRE)--Technavio has been monitoring the keto diet market and it is poised to grow by USD 1.18 billion during 2020-2024, progressing at a CAGR of almost 5% during the forecast period. The report offers an up-to-date analysis regarding the current market scenario, latest trends and drivers, and the overall market environment.

Technavio suggests three forecast scenarios (optimistic, probable, and pessimistic) considering the impact of COVID-19. Request for Technavios latest reports on directly and indirectly impacted markets. Market estimates include pre- and post-COVID-19 impact on the Keto Diet Market Download free sample report

The market is fragmented, and the degree of fragmentation will accelerate during the forecast period. Ample Foods, Ancient Nutrition, Bulletproof 360 Inc., Dang Foods Co., Essentially Keto, Fat Snax, Glanbia Plc, Perfect Keto LLC, Prvit Ventures Inc., and The Good Fat Co. Ltd. are some of the major market participants. To make the most of the opportunities, market vendors should focus more on the growth prospects in the fast-growing segments, while maintaining their positions in the slow-growing segments.

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The increasing availability of keto products has been instrumental in driving the growth of the market.

Technavios custom research reports offer detailed insights on the impact of COVID-19 at an industry level, a regional level, and subsequent supply chain operations. This customized report will also help clients keep up with new product launches in direct & indirect COVID-19 related markets, upcoming vaccines and pipeline analysis, and significant developments in vendor operations and government regulations. https://www.technavio.com/report/report/keto-diet-market-industry-analysis

Keto Diet Market 2020-2024: Segmentation

Keto Diet Market is segmented as below:

To learn more about the global trends impacting the future of market research, download a free sample: https://www.technavio.com/talk-to-us?report=IRTNTR40557

Keto Diet Market 2020-2024: Scope

Technavio presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources. Our keto diet market report covers the following areas:

This study identifies growing obese population as one of the prime reasons driving the keto diet market growth during the next few years.

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Keto Diet Market 2020-2024: Key Highlights

Table of Contents:

Executive Summary

Market Landscape

Market Sizing

Five Forces Analysis

Market Segmentation by Product

Customer landscape

Geographic Landscape

Drivers, Challenges, and Trends

Vendor Landscape

Vendor Analysis

Appendix

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COVID-19 Impact and Recovery Analysis- Keto Diet Market 2020-2024 | Increasing Availability of Keto Products to Boost Growth | Technavio - Business...

Integrating master files in the NDI notification process to facilitate innovation in dietary supplements – Regulatory Focus

Posted: June 6, 2020 at 2:53 am

This article discusses the application of master files to the new dietary ingredient notification process to protect intellectual property of ingredient manufacturers and incentivize submission of NDI notifications. The author describes an NDI master file model, based on the US drug master file, as a proposal for consideration by the US Food and Drug Administration.IntroductionInnovation grows industries, and it is no different for the dietary supplement industry. Estimated US sales for the industry reached $48.8 billion in 2019 and its growth has hovered around 5%-6% in recent consecutive years.1 Some of that success is likely attributable to innovation of products. New products, in part, emerge from formulations of new dietary ingredients (NDIs), which are ingredients that came to market after 15 October, 1994, in accordance with the Dietary Supplement Health and Education Act (DSHEA). Under the law, marketers must affirm the safety of an NDI and submit a detailed notification for review by the United States Food and Drug Administration (US FDA) at least 75 days before the NDI becomes accessible to consumers.2Since the enactment of DSHEA, the number of supplement products on the US market proliferated from 4,000 to around 80,000 in 2019, according to FDA estimates,3 and the agency has received just over 1,100 NDI notifications.4 Diverse companies have submitted NDI notifications for numerous botanical-derived ingredients, such as sea buckthorn extract, algal DHA, astaxanthin, huperzine A, and resveratrol. Other notified NDIs comprise microorganisms, including various species of Bifidobacterium (bifidum, breve, lactis, longum) and Lactobacillus (acidophilus, bulgaricus, casei, fementum, reuteri, rhamnosus, plantarum) and their various strains; enzymes, such as peptidase, pepsin, and seaprose; and a host of dietary substances from conjugated linoleic acid to krill oil to zeaxanthin.4The statistics indicate it is possible that notifications have not been submitted for all NDIs on the market. There may be many reasons for that, including a lack of clarity on exactly what an NDI is and in which cases an NDI notification must be filed (there are exemptions to the notification requirement). Industry and FDA have expressed differing views on these and other NDI-related issues since 2011,5-9 when the agency issued a draft guidance on NDI notifications, and even after the draft guidance was revised in 2016.10Although FDA does not have final guidance in place, it recognizes that NDI notification issues may present obstacles to dietary supplement innovation and proclaims the agency is examining new approaches to NDIs.11Intellectual property incentiveFDA should consider intellectual property protection as it explores incentives for companies to submit NDI notifications. Development of new ingredients requires substantial investment. Significant resources go into establishing a manufacturing process that produces a consistent, stable ingredient and generating scientific data to support the safety of the ingredient under the intended conditions of use. Companies making these investments want assurance that they can protect NDI-related intellectual property throughout the notification process, and long after, to have a competitive edge in the marketplace as a return on investment.

A master file is an elective submission to FDA that contains data deemed proprietary by a company, such as a drug ingredient manufacturer.12 The master-file submission procedure is already used extensively in the drug industry. Adding a master file component to the NDI notification process could protect the intellectual property of NDI manufacturers and facilitate the supplement industry and FDA in fulfilling NDI-related goals and, ultimately, promote consumer access to safe dietary supplements.Drug companies submit master files for a myriad drug components, including active pharmaceutical ingredients (APIs) and packaging; these drug master files (DMFs) are referenced by multiple sponsors in the context of new drug applications (NDAs) and other applications. The DMF owner, or holder, has the discretion to authorize any third party to reference its DMF by issuing a letter of authorization (LOA). LOAs, along with a list of authorized parties, are submitted with the DMF.

This authorization permits the authorized party to reference the master file, but not to review its contents, and FDA reviews the relevant parts of the master file in accordance with the LOA. Implementation of the DMF has allowed API manufacturers, for instance, to protect intellectual property related to their APIs, while seamlessly facilitating the drug approval process by reducing the need to submit information of the same type across different NDAs. In Canada, natural health product master files (NHP-MF) are commonly referenced in product licensing applications. The NHP-MF submission procedures and requirements are similar to those for DMFs in the US.As with drug and natural health product companies, dietary supplement companies could benefit from the addition of the master file to the premarket process, that is, the NDI notification. Implementation of an NDI master file (NDI-MF) system avails dietary ingredient manufacturers of the option to seek protection of intellectual property generated through research and development of an NDI, such as information regarding manufacturing, processing and safety.

Once the NDI-MF has been submitted to FDA, it may be referenced, with permission from the NDI-MF holder, by those submitting NDI notifications. The entire NDI notification process is streamlined if NDI-MF data can be referenced by multiple submitters of NDI notifications, and the paperwork burden is reduced because it is possible to submit NDI notifications in an abbreviated manner. An NDI-MF may be referenced by various ingredient manufacturers that desire to include the proprietary NDI in a novel ingredient blend, or by supplement manufacturers that plan to use the proprietary NDI in a new formulation outside the conditions of use established in the NDI-MF. In both hypothetical situations, the NDI notifications submitted to FDA may simply reference the NDI-MF and be abbreviated.It would also be advantageous for FDA to accept master files. The agency would play a vital role in protecting intellectual property and likely face fewer instances of duplicative notifications, which slow down review efficiency, once master files are in place. FDA has responded positively to supplement industry calls to incorporate NDI master files into the NDI notification process.13

In its 2016 revised draft guidance, the agency explains that a company may submit a confidential NDI master file, incorporate the contents of the master file into an NDI notification, and authorize other firms to reference the master file in notifications.14 Furthermore, firms relying on the master file should provide documentation, such as a signed letter, that specifies the relevant parts of the master file included in the authorization. However, although FDA elaborated on the NDI master file concept in guidance, it did not clarify a submission process or how firms might identify existing NDI master files.Industry-proposed framework for NDI master filesExisting and long-standing approaches to master files may be adapted for NDIs. The DMF system has persisted since the 1940s, evolved over time, and served as a model for a framework for the NDI-MF. A supplement industry proposal tailored for NDIs contains all the key elements shared among master file systems, including initial administrative review of submissions and assignment of a master file number by FDA, authorization procedures and requirements, master file updates and closure, and public availability of master file information (Table).Table. Key elements of a proposed NDI master file framework

ConclusionThe NDI-MF is an optional and useful tool for the dietary supplement industry as well as FDA. Other industries have successfully used master files to protect intellectual property. Borrowing from major elements of the DMF, the supplement industry has adapted a framework for NDI-MFs. FDA should consider the industrys proposal and implement a system for accepting and reviewing NDI-MFs as part of NDI notifications to facilitate innovation in dietary supplements.

AbbreviationsAPI, active pharmaceutical ingredients; DHA, docosahexaenoic acid; DMF, drug master file; DSHEA, Dietary Supplement Health and Education Act; FDA, Food and Drug Administration; LOA, letter of authorization; NDA, new drug applications; NDI, new dietary ingredient; NDI-MF, new dietary ingredient master file; NHP-MF, natural health product master file.References

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Integrating master files in the NDI notification process to facilitate innovation in dietary supplements - Regulatory Focus

Ask the Doctors: Gastroparesis treated primarily with diet – Times Record

Posted: June 6, 2020 at 2:53 am

Ask the Doctors: Gastroparesis treated primarily with diet

Dear Doctor: My husband started having a lot of stomach pain and was also feeling queasy. Needless to say, I feared the worst cancer but, instead, his doctor says it's gastroparesis. Is it dangerous? What's the best treatment?

Dear Reader: Gastroparesis is the name of a condition in which the stomach is slow to empty its contents into the small intestine. This isn't due to any type of blockage. Instead, as the name of the condition suggests ("gastro" refers to the stomach, and "paresis" indicates nerve-related muscle weakness), the cause is a malfunction in the nerves that serve the region. This includes the vagus nerve, which animates the stomach muscles and helps send food to the small intestine. Symptoms include the pain and nausea your husband experienced, as well as poor appetite, feeling full after only small amounts of food or drink, heartburn and unintended weight loss.

When functioning properly, the stomach takes about four hours to saturate its contents with gastric juices, break everything up into smaller particles and pass the majority of it along to the small intestine. For people living with gastroparesis, the process takes significantly longer.

The result is delayed digestion, which can lead to a range of problems. Food that remains in the stomach for too long is susceptible to fermentation, which can encourage the growth of bacteria. The condition can interfere with appetite and sometimes leads to malnutrition. When the contents of the stomach are stalled, they can coagulate into a mass known as a bezoar, which can cause a blockage. And for people living with diabetes, the delayed movement of food from the stomach to the small intestine can interfere with glucose control.

Gastroparesis is often seen in people living with diabetes, which can cause nerve damage. It may also arise as the result of viral stomach infections, hypothyroidism, certain autoimmune or neurological disorders, or surgical injury. It's a known (albeit rare) side effect of medications such as opioids, antihistamines, tricyclic antidepressants and calcium-channel blockers, which can impede digestion.

Diet is important in the management of gastroparesis, with an emphasis on nutrient density and ease of digestion. Patients are asked to eat small meals of soft, well-cooked food, and to avoid high-fat foods, which delay the emptying of the stomach. Foods high in fiber are difficult to digest and are also limited, or in some cases eliminated. Fruits and vegetables, which contain nondigestible fiber, should be served cooked, and in some cases pureed. For instance, instead of an apple, a patient will have a small serving of applesauce. They are also encouraged drink liquids that contain glucose and electrolytes, including clear soups, low-fat broths, low-fiber fruit and vegetable juices, or sports drinks. Since glucose control and malnutrition are both a challenge, many people with gastroparesis work with a registered dietitian.

When the condition can't be managed with diet, medications that cause the stomach to contract and emerging therapies such as electrical gastric stimulation may be an option. In severe cases, surgery may be necessary. We recommend that your husband seek out a gastroenterologist to fully assess his case and plan his treatment.

Eve Glazier, M.D., MBA, is an internist and associate professor of medicine at UCLA Health. Elizabeth Ko, M.D., is an internist and assistant professor of medicine at UCLA Health.

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Ask the Doctors: Gastroparesis treated primarily with diet - Times Record

What is the pescatarian diet? Everything you need to know – CNET

Posted: June 6, 2020 at 2:53 am

Seafood, like salmon, is a staple in the pescatarian diet.

There's a war raging in the health and wellness world that doesn't look like it will end anytime soon. The fight over whether meat or animal-based food products are actually good for you or not has been a long one. But given that the science and expert advice on the topic is so mixed, you might be interested in an eating style that gives you the best of both worlds and allows some non-plant based, but also non-meat protein sources. Enter the pescatarian diet.

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A pescatarian diet is an eating style that looks similar to a vegetarian diet, except most pescatarians eat fish. "Pescatarianism is essentially veganism, or in other words, an entirely plant-based approach, but the only animal protein consumed is fish," Kylene Bogden, Registered Dietician and Wellness Advisor for Love Wellness tells CNET. However, some also include dairy and eggs, but it depends on the person's preference.

The pescatarian diet is appealing to many people since one of the main concerns surrounding veganism and vegetarian diets is that you often can't get enough complete protein from plants. Most plants do not contain the nine essential amino acids that are found in animal protein and seafood that constitute a "complete" protein. So the pescatarian diet excludes all forms of meat including red meat, chicken, turkey and pork but you can include any type of seafood, such as salmon, tilapia, shrimp or oysters.

In general, adding more plants and less processed foods into your diet provides many benefits like less inflammationand a lower risk for chronic health conditions like heart disease, type 2 diabetes and high blood pressure.

Fish contains omega-3 fatty acids which health experts say support heart health, among other benefits. According to an American Heart Association science advisory including as little as 1-2 meals with seafood per week can reduce your risk for congestive heart failure, coronary heart disease, stroke and sudden cardiac death. They also stress that these benefits can occur when replacing less healthy meals with fish or seafood.

Studies show that diets with more seafood can have a positive effect on heart health.

Studies also show that people who consume more omega-3 fatty acids, like those found in fish, can experience less depression and anxiety. According to Harvard Health, this may be because the human brain contains a high amount of fatty acids. So researchers guess that when the brain has less of those fats available, it may result in health issues that affect the brain like anxiety, depression or even Parkinson's Disease.

A diet rich in fruits, veggies, and seafood is shown to help lower the risk for diabetes.

Plant-based, vegetarian and pescatarian diets were shown to protect people against obesity and type 2 diabetes in one study published in Diabetes Care.In the study, researchers measured BMI of vegetarians, vegetarians that eat eggs and pescatarians. They found that vegetarians had the lowest risk for diabetes and a lower body mass index (BMI). Pescatarian's BMI were also lower than their meat-eating counterparts.

No matter what your health goals, some people simply feel better when they eat more plants and less meat and rely on seafood as their main protein source."Many individuals feel well eating an abundance of plants with a small amount of animal protein that is easily digested such as fish hence why many choose the approach," Bogden says.

One benefit of the pescatarian diet is that it's really flexible and you can adapt it to your tastes and preferences. There are no "rules" or guidelines other than the kinds of protein you eat and it's up to you if you'd like to include dairy products like cheese or yogurt and eggs.

If you have other goals, like losing weight or gaining muscle for example, you may need to consult a nutritionist on the exact amounts of food and macronutrient ratios that will help you reach those goals.

Types of food you can eat on the pescatarian diet:

Depending on your preference:

Certain types of fish are more likely to have high levels of mercury than others.

When adopting a diet rich in fish and seafood, some people are concerned about consuming the mercury that is found in some fish. Too much mercury in someone's diet can result inmercury toxicity, although the risk is considered low. "Mercury toxicity is a very real issue, but at the same time, is only an issue if an abundance of poor quality, farm raised fish is consumed," Bogden says.

Luckily, not all fish contain the same amount of mercury -- just be mindful of what you're eating to reduce your exposure to it. Here are the guidelines for reducing risk according to Seafood Health Facts:

Fish with high levels of mercury to avoid:

Commonly eaten seafood low in mercury:

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

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Insights on the Worldwide Insoluble Dietary Fibers Industry to 2025 – Featuring Cargill, Roquette Freres & Archer Daniels Midland Among Others -…

Posted: June 6, 2020 at 2:53 am

Dublin, June 05, 2020 (GLOBE NEWSWIRE) -- The "Insoluble Dietary Fibers Market - Forecast (2020 - 2025)" report has been added to ResearchAndMarkets.com's offering.

The global insoluble dietary fibers market is estimated to be $1,965m in 2020 and projected to grow at a CAGR of 7.8% during 2020-2025 in terms of value however volume sales is poised to witness higher growth during the forecasting period.

The Asia Pacific region is estimated to be the fastest developing market for insoluble dietary fibers. This is because of the rising demand for functional food as well as the change in the lifestyles of the population. Followed by Europe and North America because of the rising demand for dietary and health supplements. The global insoluble dietary fibers market is estimated to reach 762.4KT in terms of value by 2021 growing at a CAGR of 8.8 % during the forecast period from 462KT in 2020.

Insoluble Dietary Fibers Market Outlook:

Hemi-cellulose & cellulose holds major share in the global insoluble dietary fibers market in 2020 with volume shares of 24.5% and 30.3% respectively. Chitin & Chitosan type of insoluble dietary fibers are estimated to witness rapid growth both in terms of volume & value during the forecast period. Food & Beverages is the major market for insoluble dietary fibers globally and it is estimated to continue its growth both in terms of volume & value during the forecast period.

Insoluble Dietary Fibers Market Growth drivers:

The consumer's inclination towards fiber rich products, increasing demand for functional foods and abundant availability of raw materials is driving the growth of the insoluble dietary market. Booming functional food industry outgrowth the usage of dietary fibers. Additionally the growing population of insoluble dietary fiber as a nutritional ingredient.

Insoluble Dietary Fibers Market Challenges:

Escalating competition within dietary fiber segments and among various nutritive ingredients stands as a challenge for the growth of insoluble dietary fibers. In addition reduction of anti-nutrient components in cereals brans for their use in nutritional products stands as a challenge

Insoluble Dietary Fibers Market Research Scope:

The base year of the study is 2020, with forecast done up to 2025. The study presents a thorough analysis of the competitive landscape, taking into account the market shares of the leading companies. It also provides information on unit shipments. These provide the key market participants with the necessary business intelligence and help them understand the future of the Insoluble Dietary Fibers Market. The assessment includes the forecast, an overview of the competitive structure, the market shares of the competitors, as well as the market trends, market demands, market drivers, market challenges, and product analysis. The market drivers and restraints have been assessed to fathom their impact over the forecast period. This report further identifies the key opportunities for growth while also detailing the key challenges and possible threats. The key areas of focus include the types of plastics in the electric vehicle market, and their specific applications in different types of vehicles.

Market Research and Market Trends of Insoluble Dietary Fibers Market

Key Topics Covered:

1. Insoluble Dietary Fibers Market- Overview1.1. Definitions and Scope

2. Insoluble Dietary Fibers Market- Executive summary2.1. Market Revenue, Market Size and Key Trends by Company2.2. Key Trends by type of Application2.3. Key Trends segmented by Geography

3. Insoluble Dietary Fibers Market-Comparative analysis3.1. Product Benchmarking - Top 10 companies3.2. Top 5 Financials Analysis3.3. Market Value split by Top 10 companies3.4. Patent Analysis - Top 10 companies3.5. Pricing Analysis

4. Insoluble Dietary Fibers Market- Market Forces4.1. Drivers4.2. Constraints4.3. Challenges4.4. Porters five force model4.4.1. Bargaining power of suppliers4.4.2. Bargaining powers of customers4.4.3. Threat of new entrants4.4.4. Rivalry among existing players4.4.5. Threat of substitutes

5. Insoluble Dietary Fibers Market-Strategic analysis5.1. Value chain analysis5.2. Opportunities analysis5.3. Product life cycle

6. Insoluble Dietary Fibers Market- By Type (Market Size -$Million / $Billion)6.1. Market Size and Market Share Analysis 6.2. Application Revenue and Trend Research6.3. Product Segment Analysis6.3.1. Hemicellulose6.3.2. Lignin6.3.3. Cellulose6.3.4. Resistant Starch6.3.5. Chitin & Chitosan6.3.6. Fiber6.3.7. Others

7. Insoluble Dietary Fibers Market- By Function (Market Size -$Million / $Billion)7.1. Anti-caking Agent7.2. Bulking/ Texturing Agent7.3. Fat Substitute7.4. Water binding Agent

8. Insoluble Dietary Fibers Market- By Source(Market Size -$Million / $Billion)8.1. Whole Grain8.1.1. Wheat8.1.2. Corn8.1.3. Rice8.1.4. Oats8.1.5. Others8.2. Vegetables8.2.1. Green leafy vegetables8.2.1.1. Spinach8.2.1.2. Carrot8.2.1.3. Cabbage8.2.1.4. Others8.3. Fruits8.3.1. Orange8.3.2. Grapefruit8.3.3. Apricots8.3.4. Mango8.3.5. Peach8.3.6. Banana8.4. Others

9. Insoluble Dietary Fibers Market- By End Use Industry (Market Size -$Million / $Billion)9.1. Market Size and Market Share Analysis 9.2. Application Revenue and Trend Research9.3. Product Segment Analysis9.3.1. Food Industry9.3.1.1. Breakfast Cereals9.3.1.2. Bakery9.3.1.3. Dairy Products9.3.1.4. Meat and Poultry food9.3.1.5. Pasta & Tortillas9.3.2. Animal Feed Industry9.3.3. Pharmaceutical9.3.4. Others

10. Insoluble Dietary Fibers Market- By Geography (Market Size -$Million / $Billion)10.1. Insoluble Dietary Fibers Market - North America Segment Research10.2. North America Market Research (Million / $Billion)10.2.1. Segment type Size and Market Size Analysis 10.2.2. Revenue and Trends10.2.3. Application Revenue and Trends by type of Application10.2.4. Company Revenue and Product Analysis10.2.5. North America Product type and Application Market Size10.2.5.1. U.S.10.2.5.2. Canada 10.2.5.3. Mexico 10.2.5.4. Rest of North America10.3. Insoluble Dietary Fibers Market- South America Segment Research10.4. South America Market Research (Market Size -$Million / $Billion)10.4.1. Segment type Size and Market Size Analysis 10.4.2. Revenue and Trends10.4.3. Application Revenue and Trends by type of Application10.4.4. Company Revenue and Product Analysis10.4.5. South America Product type and Application Market Size10.4.5.1. Brazil 10.4.5.2. Venezuela10.4.5.3. Argentina10.4.5.4. Ecuador10.4.5.5. Peru10.4.5.6. Colombia 10.4.5.7. Costa Rica10.4.5.8. Rest of South America10.5. Insoluble Dietary Fibers Market- Europe Segment Research10.6. Europe Market Research (Market Size -$Million / $Billion)10.6.1. Segment type Size and Market Size Analysis 10.6.2. Revenue and Trends10.6.3. Application Revenue and Trends by type of Application10.6.4. Company Revenue and Product Analysis10.6.5. Europe Segment Product type and Application Market Size10.6.5.1. U.K 10.6.5.2. Germany 10.6.5.3. Italy 10.6.5.4. France10.6.5.5. Netherlands10.6.5.6. Belgium10.6.5.7. Spain10.6.5.8. Denmark10.6.5.9. Rest of Europe10.7. Insoluble Dietary Fibers Market- APAC Segment Research10.8. APAC Market Research (Market Size -$Million / $Billion)10.8.1. Segment type Size and Market Size Analysis 10.8.2. Revenue and Trends10.8.3. Application Revenue and Trends by type of Application10.8.4. Company Revenue and Product Analysis10.8.5. APAC Segment - Product type and Application Market Size10.8.5.1. China 10.8.5.2. Australia10.8.5.3. Japan 10.8.5.4. South Korea10.8.5.5. India10.8.5.6. Taiwan10.8.5.7. Malaysia10.8.5.8. Hong Kong 10.8.5.9. Rest of APAC10.9. Insoluble Dietary Fibers Market- Middle East Segment and Africa Segment Research10.10. Middle East & Africa Market Research (Market Size -$Million / $Billion)10.10.1. Segment type Size and Market Size Analysis 10.10.2. Revenue and Trend Analysis10.10.3. Application Revenue and Trends by type of Application 10.10.4. Company Revenue and Product Analysis10.10.5. Middle East Segment Product type and Application Market Size10.10.5.1. Israel 10.10.5.2. Saudi Arabia10.10.5.3. UAE10.10.6. Africa Segment Analysis10.10.6.1. South Africa10.10.6.2. Rest of Middle East & Africa

11. Insoluble Dietary Fibers Market- Entropy11.1. New product launches11.2. M&A's, collaborations, JVs and partnerships

12. Insoluble Dietary Fibers Market Company Analysis12.1. Market Share, Company Revenue, Products, M&A, Developments12.2. Cargill Inc.12.3. J.Reltenmaier & Sohne Gmbh & CoKg.12.4. Roquette Freres12.5. Archer Daniels Midland12.6. Ingredient Inc.12.7. E.I.DuPont De Nemours and Company

13. Insoluble Dietary Fibers Market-Appendix13.1. Abbreviations13.2. Sources

For more information about this report visit https://www.researchandmarkets.com/r/fkdedy

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Insights on the Worldwide Insoluble Dietary Fibers Industry to 2025 - Featuring Cargill, Roquette Freres & Archer Daniels Midland Among Others -...


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