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Jun 6

Dementia: The diet proven to protect against brain decline – what foods to eat – Express

One of the most promising developments is the link between certain diets and their protective components.

According to Mays Al-Ali, nutritionist at HealthyMays.com

The DASH diet also protects against many cardiovascular risk factors of dementia, said Al-Ali.

The DASH diet plan emphasises high intakes of fruits, vegetables, whole grains, and low-fat dairy products, as well as increased potassium and reduced sodium intake.

"Some of the dementia protective effects of DASH include lower blood pressure and blood lowdensity lipoprotein (LDL) cholesterol levels, weight reduction, reduced oxidative stress and inflammation, improved insulin sensitivity, and reduced incidence of diabetes," explains Al-Ali.

Devising a diet to address the drawbacks

As she explained, although both the Mediterranean-based diet and the blood pressurelowering DASH have demonstrated protective effects on cardiovascular conditions that can adversely affect the brain, neither is specific for the levels and types of foods shown to protect the brain against neurodegeneration.

, there are two main diets that have come under the microscope - the Dietary Approaches to Stop Hypertension (DASH) diet and the Mediterranean-style diet.

As Al-Ali explains, a Mediterranean-style diet is rich in fruits, vegetables, legumes and unrefined cereals, with moderate amounts of dairy products, low meat but regular fish intake.

"This seems to deliver all nutrients in adequate amounts to support maintenance of cognitive function and reduce the risk of cognitive decline in healthy older persons," she said.

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The DASH diet also protects against many cardiovascular risk factors of dementia, said Al-Ali.

The DASH diet plan emphasises high intakes of fruits, vegetables, whole grains, and low-fat dairy products, as well as increased potassium and reduced sodium intake.

"Some of the dementia protective effects of DASH include lower blood pressure and blood lowdensity lipoprotein (LDL) cholesterol levels, weight reduction, reduced oxidative stress and inflammation, improved insulin sensitivity, and reduced incidence of diabetes," explains Al-Ali.

As she explained, although both the Mediterranean-based diet and the blood pressurelowering DASH have demonstrated protective effects on cardiovascular conditions that can adversely affect the brain, neither is specific for the levels and types of foods shown to protect the brain against neurodegeneration.

Among the different types of vegetables, the green leafy variety has been identified as having the strongest protective effects against cognitive decline, she noted.

"Studies show that adults aged 50 plus who followed a similar eating plan based on the MIND diet for four years did not experience any memory loss and after only four months on this type of eating plan, adults performed as if they were nine years younger on reading and writing speed tests," Al-Ali reported.

According to Al-Ali, these are the main foods to be eaten regularly whilst limiting intake of red meat, processed products and baked goods:

1) Raw leafy greensDarker greens, such as spinach, kale and romaine, have more brain-boosting antioxidants and vitamin K. Try to eat one cup daily.

2) Cruciferous vegetablesBroccoli, cauliflower and brussels sprouts are high in vitamin K and glucosinolates, which have an antioxidant effect. Include at least three 1/2 cup servings in your diet a week.

3) BlueberriesAll berries have a positive effect on brain health, but blueberries have been studied the most. They contain flavonoids, which activate brain pathways associated with less cellular ageing. Try to consume 1/2 cup of any berries three times a week.

4) BeansIts unknown exactly what makes beans, lentils and chickpeas good for brain health, but its likely due to a combination of antioxidants, fibre, vitamins and minerals. Include 1/2 cup in your diet as a replacement for red meat at least twice a week.

5) NutsUnsalted nuts are high in antioxidants and healthy fats. Walnuts are particularly high in omega-3 fatty acid, a brain-protective nutrient. Aim for a handful of nuts daily.

6) FishThe iodine and iron in all types of fish are thought to help maintain cognitive function. Fattier fish, like salmon and trout, also contain brain-boosting omega-3 fatty acids. Aim for one to two servings per week.

7) Whole grainsChoose fibre-rich whole grains like oats, brown rice and whole-grain wheat to offset your intake of refined grains.

8) Olive oilIt contains monounsaturated fats and vitamin E, as well as antioxidants. Aim for extra virgin organic olive oil and try not to fry with it as it has a low smoke point so can go rancid easily and give rise to inflammation. Add it to cooked food once cooled or on salad dressings. Avocado or coconut oil is best for cooking.

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Dementia: The diet proven to protect against brain decline - what foods to eat - Express


Jun 6

What Can You Drink While Intermittent Fasting? – Women’s Health

Intermittent fasting (IF), an eating style that's typically paired with high-protein or keto diets, begs a lot of questions, especially if you're new to it. You might be curious what type of fasting schedule you should try, what the legit health benefits are, whether you'll experience any side effects, and what kind of weight-loss results you can expect. Another common question is whether you can have beverages, like coffee and water, during your fasting periods.

The short answer is: It depends on the beverage and the type of IF diet you're following (different types of intermittent fasting, from dry fasting to the Warrior Diet, have different guidelines). But a good rule of thumb is to avoid any drinks that have any calories while you're fasting, says New Jersey-based dietitian Erin Palinski-Wade, RD, author of 2 Day Diabetes Diet.

Consuming any carbs, proteins, or fats when you're trying to maintain a fasted state can negate the weight-loss benefits of intermittent fasting, she says. IF diets are also thought to lead to a reduction in insulin resistance and help control blood sugar, both of which can reduce your chances of becoming diabetic. These benefits can be quickly canceled out if you consume too many liquid calories during a period of what should be a fasted state.

Here's what you should know about all some of the most popular drinks you might *want* to consume while doing intermittent fasting, and whether or not they'll take you out of a fasted state.

You can drink it black. Black coffee is calorie-free, so it's fine to enjoy during the fasting phase. But adding in sugar, cream, or milk is best avoided, as it can add calories to the drink that can take you out of a fasted state.

If you do want to flavor your coffee during a fast, experiment with calorie-free flavoring from a spice like cinnamon, says Palinski-Wade. Save the coffee add-ons for your non-fast windows of time."

Additionally, avoid having more than one cup, or switch to decaf, when you're fasting. Excessive caffeine, especially on an empty stomach, may increase those jittery feelings which can often increase appetite and the desire to snack, she says.

Go for it. Just like coffee, tea is naturally calorie-free and fine to have during a fast, so long as its simply brewed tea that comes from tea bags, leaves, or flakes. Bottled ice tea is often heavily sweetened, so if you go that route, make sure youre opting for one that is unsweetened and not loaded with added sugar and calories, says Palinski-Wade. Caloric add-ons such as honey, milk or cream should be reserved for non-fasting times, just like with coffee.

Since tea is naturally lower in caffeine than coffee, you can have a bit more during fasts, however I would still recommend opting for decaf when possible, she says.

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Drink up. Water is naturally calorie-free so there's no need to restrict it, says Palinski-Wade. Water in general is a good idea to sip on during fasting times to ensure hydration but also as a way to fill your stomach and prevent hunger.

If you enjoy flavored water, you can add in fruit wedges or a splash of lemon or lime juice (or a splash of another juice) as long as it is a true "splash" (around one tablespoon per 12 ounces) and doesnt add more than a trivial amount of calories, says Palinski-Wade. Carbonated water/seltzer can be treated in the same way as water, as long as it is naturally flavored and calorie-free.

Skip it. If you're wondering if you can drink soda (or diet soda) while you're doing intermittent fasting, Palinski-Wade recommends staying away from soda in general, even if youre not following a diet like intermittent fasting.

Regular sodas are usually loaded with sugar and calories and offer no nutritional value, she says. There also isnt enough data and research to say whether diet soda is okay to drink during IF, but research suggests that consuming too many artificial sweeteners (as diet sodas tend to have) can increase cravings and appetite, as well as promote weight gain and the storage of fat.

Your best bet is to limit all sodas as much as possible and satisfy carbonation cravings with seltzer or carbonated water, she says.

Pass on it. Alcohol should never be consumed when in a fasting period, as its effects can be intensified when consumed on an empty stomach, says Palinski-Wade. Alcohol is also a source of calories, so drinking it would break your fast while also likely stimulating your appetite and leading to increased hunger and cravings.

This depends on the fasting schedule you're following, and you should discuss any supplements with your doctor before beginning to take them, says Palinski-Wade. If you fast for a set amount of hours each day, take your supplements during the eating hours (unless otherwise instructed by your doctor or dietitian), since most supplements like a multivitamin are better absorbed when taken with food.

If you practice intermittent fasting that involves fasting on specific days, like the 5:2 diet, taking supplements is still recommended to ensure you are meeting your nutrient needs each day. Palinski-Wade recommends taking a high-quality multivitamin daily when following any IF plan.

Generally, the small amount of calories found in a chewable/gummy/liquid vitamin would not offset a fast day, she says. "But do discuss this with your doctor or dietitian first to make sure you can take your supplement on an empty stomach.

The bottom line: At the end of the day, you want to consume close to zero calories during fasting periods. By avoiding sweetened drinks like soda and bottled iced tea, as well as caloric add-ons in your hot beverages, you can ensure you follow your IF plan correctly and successfully.

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What Can You Drink While Intermittent Fasting? - Women's Health


Jun 6

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

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


Jun 6

5 liver-healthy foods you must include in your diet to stay hale and hearty – Times Now

5 liver-healthy foods you must include in your diet to stay hale and hearty  |  Photo Credit: iStock Images

New Delhi: The human body is a complex machine. Just like if one part of any machine is unable to work efficiently, or completely breaks down, even if one vital organ of the body is unable to perform its functions, it can lead to complications and problems in the body. The food we eat, directly affects our whole body, including all our internal organs, like the liver.

A healthy, balanced diet, along with regular exercise, and quitting unhealthy lifestyle habits like smoking, or drinking can help in keeping the body healthy overall. However, if you are diagnosed with a specific problem, you must change your diet accordingly. While some foods can aggravate the problem, others can help strengthen the organ and aid its functions. According to British Liver Trust, if you have a liver condition, it's important to understand how your liver is affected by the food you eat; the elements of a well-balanced diet suitable for most people; disease-specific dietary considerations and special or therapeutic nutritional diets for those with more advanced liver disease.

Disclaimer: Tips and suggestions mentioned in the article are for general information purposes only and should not be construed as professional medical advice. Always consult your doctor or a professional healthcare provider if you have any specific questions about any medical matter.

For full coverage on Coronavirus pandemic, click here.Join the Times Group initiative #MaskIndia.Share a picture with your home-made mask on your social handles using #MaskIndia. The best picture will be featured in TOI and on maskindia.com

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5 liver-healthy foods you must include in your diet to stay hale and hearty - Times Now


Jun 6

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

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:

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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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Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavios report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavios comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

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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...


Jun 6

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

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


Jun 6

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

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.

Read more:The best healthy food delivery services for 2020: Blue Apron, Home Chef, Sun Basket and more

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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.

Link:
What is the pescatarian diet? Everything you need to know - CNET


Jun 6

Vitamin D deficiency: The subtle pain you should never ignore – it could be serious – Express

The vitamin is needed to regulate the amount of calcium and phosphate in the body.

A lack of vitamin D can lead to serious complications, including osteomalacia, rickets, or some deformities.

But, the symptoms of a vitamin D deficiency can be very difficult to spot.

One of the hidden warning signs of the condition is having severe bone pain, it's been revealed.

READ MORE: Vitamin D deficiency symptoms - what can you smell?

"Severe lack of vitamin D causes rickets, which shows up in children as incorrect growth patterns, weakness in muscles, pain in bones and deformities in joints," said the Cleveland Clinic.

"This is very rare. However, children who are deficient in vitamin D can also have muscle weakness or sore and painful muscles.

"Lack of vitamin D is not quite as obvious in adults.

"Signs and symptoms might include fatigue, bone pain, muscle weakness, muscle aches, or muscle cramps, and mood changes, like depression."

Read more from the original source:
Vitamin D deficiency: The subtle pain you should never ignore - it could be serious - Express


Jun 6

Free food distribution for people with special dietary needs held in Lansdale – Montgomery Newspapers

LANSDALE Garden of Health, which provides food for those with special dietary needs, held a contactless free food pickup the morning of June 4 at the Lansdale Business Center.

A dozen eggs, a box of USDA produce, a box of Homefree cookies and a box of food from gluten-free food donated by Schr USA was being given to each of the vehicles coming through the drive-through pick up, Garden of Health founder Carol Bauer said.

Enough boxes for 200 pick-ups had been placed out, with additional ones available, she said.

We're prepared for 250, Bauer said.

More than 100 vehicles made pick-ups, the organization later posted on social media.

This is the first time Garden of Health held this type of food distribution, Bauer said.

Hopefully, we'll be able to do it again, she said.

Garden of Health provides allergen-friendly, gluten-free food and fresh produce to more than 25 food pantries and, since the onset of the coronavirus pandemic, has added providing food for community meal programs started or expanded during the pandemic, as well as distributing food to more than 100 private clients in need of special dietary foods, according to a Garden of Health release.

If another drive-through pick up is held, another location will have to be found for it because the Lansdale Business Center space will no longer be available after the middle of June, Bauer said.

We have another tractor trailer of Schr products waiting for us, but their (Lansdale Business Center) space is taken, so we need to find another location that can take a tractor trailer full of food, she said.

The Clemens Food Group donated the use of a refrigerated trailer for the produce and eggs in the June 4 distribution, she said.

Before the start of the food distribution, a $13,500 contribution to Garden of Health was made by the Harleysville Rotary Club.

They're doing excellent work, Gary Volpe, president of the Harleysville Rotary, said about Garden of Health.

He also lauded Bauer's leadership of the organization.

Her heart is incredible and the work she puts forward is also incredible, he said.

Bauer said the Harleysville Rotary has also assisted in other ways, including with volunteer work at Garden of Health's garden in which fresh produce is raised.

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Free food distribution for people with special dietary needs held in Lansdale - Montgomery Newspapers


Jun 6

5 false claims about coronavirus remedies and why they are wrong – Medical News Today

Have you ever heard that taking vitamin D supplements or following a ketogenic (keto) diet will protect you from the new coronavirus? In this Special Feature, we explain why these and other persistent myths are not grounded in science.

Even before the World Health Organization (WHO) declared the new coronavirus outbreak a pandemic, their director general, Dr. Tedros Adhanom Ghebreyesus, warned of the danger associated with spreading false information about the virus.

At a conference on February 15, 2020, he declared that were not just fighting an epidemic; were fighting an infodemic.

Fake news spreads faster and more easily than this virus and is just as dangerous, he emphasized.

However, it can be difficult to tell what is credible and what is not given the sheer quantity of information that people are sharing both on and offline.

Previously on Medical News Today, we compiled a list of 28 myths surrounding the new coronavirus (SARS-CoV-2). In this Special Feature, we will take an in-depth look at five more persistent myths and explain why people should not take them at face value.

Some articles claim that if a person takes vitamin D supplements, they will be less likely to contract SARS-CoV-2.

In part, people have based these claims on a controversial paper that appears in the journal Aging Clinical and Experimental Research.

The papers authors claim to have found a correlation between low mean levels of vitamin D in the populations of certain countries and higher rates of COVID-19 cases and related deaths in those same countries.

Based on this correlation, the authors hypothesize that supplementing the diet with vitamin D may help protect against COVID-19. However, there is no evidence to suggest that this would actually be the case.

In a rapid review of the evidence published on May 1, 2020, researchers from the Centre for Evidence-Based Medicine at the University of Oxford in the United Kingdom unequivocally conclude: We found no clinical evidence on vitamin D in [the prevention or treatment of] COVID-19.

They also write that [t]here was no evidence related to vitamin D deficiency predisposing to COVID-19, nor were there studies of supplementation for preventing or treating COVID-19.

Other researchers who have conducted reviews of the existing data surrounding a potential relationship between vitamin D and COVID-19 agree.

One report by specialists from various institutions in the U.K., Ireland, Belgium, and the United States which appeared in BMJ Nutrition, Prevention & Health in May 2020 also points to a lack of supporting evidence in favor of taking vitamin D supplements to prevent infection with SARS-CoV-2.

The reports authors warn that:

[C]alls [for high dose vitamin D supplementation as a preventive strategy against COVID-19] are without support from pertinent studies in humans at this time, but rather based on speculations about presumed mechanisms.

They also note that although sufficient vitamin D can contribute to overall good health on a day-to-day basis, taking supplements without first seeking medical advice can be harmful.

For example, taking too much vitamin D in the form of a dietary supplement could actually jeopardize health, especially among people with certain underlying chronic conditions.

Another widespread rumor is that taking zinc supplements could help prevent infection with SARS-CoV-2 or treat COVID-19.

It is true that zinc is an essential mineral that helps support the functioning of the human immune system.

Starting from this notion, a team of researchers from Russia, Germany, and Greece hypothesized that zinc might be able to act as a preventive and adjuvant therapeutic for COVID-19. Their results appear in the International Journal of Molecular Medicine.

The researchers refer to in vitro experiments that apparently showed that zinc ions were able to inhibit the action of a certain enzyme that facilitates the viral activity of SARS-CoV-2.

However, they also point out the lack of actual clinical evidence that zinc might have an effect against SARS-CoV-2 in humans.

Other papers that cite the potential of zinc as an adjuvant in COVID-19 therapy including one that appears in Medical Hypotheses are more speculative and not based on any clinical data.

In a Practice patterns and guidelines paper from April 2020 which appears in BMJ Nutrition, Prevention & Health nutritionist Emma Derbyshire, Ph.D., and biochemist Joanne Delange, Ph.D., reviewed existing data about zinc (alongside other nutrients) in relation to viral respiratory infections.

They found that, according to available research in humans, zinc supplementation may help prevent pneumonia in young children, and that zinc insufficiency may impair immune responses in older adults.

However, they note that there is not enough evidence about the role of zinc supplementation in preventing viral infections in general.

Rigorous trials [] are yet to determine the efficacy of zinc supplementation, they write.

Vitamin C is another essential nutrient that has received a lot of attention. Many people believe that it can prevent or even cure the flu or common cold.

Although it is true that sufficient vitamin C can help support immune function, current evidence regarding its effectiveness in treating or preventing colds and influenza is limited and often contradictory.

Despite this, there have been claims that this vitamin might help fight infections with the new coronavirus.

It is possible that people are basing these claims on an existing ongoing clinical trial in China, which is looking at the effects of high dose intravenous (IV) vitamin C on hospitalized patients receiving care for severe COVID-19.

The researchers expect to complete the trial by the end of September 2020. No results are available in the interim.

Commenting on the trial, experts from the Linus Pauling Institute which focuses on health and nutrition at Oregon State University in Corvallis explain that although high dose IV vitamin C might help alleviate COVID-19 symptoms in severely ill patients, regular vitamin C supplements are very unlikely to help people fight off infections with SARS-CoV-2.

The experts warn that IV vitamin C is not the same as taking vitamin C supplements, as they would never raise blood levels of this vitamin as highly as an IV infusion would.

They also warn people who may be tempted to up their dosage of vitamin C of the fact they could end up taking too much and experiencing adverse side effects.

Keto diets, which are high in fats and low in carbohydrates, have also received some attention in the context of treating or preventing COVID-19.

This may be because there is some evidence to suggest that keto diets could help boost the immune system. However, much of that evidence is based on animal studies rather than human trials.

Also, an upcoming clinical trial from Johns Hopkins University in Baltimore, MD, proposes to look at whether or not a ketogenic intervention might help intubated COVID-19 patients by reducing inflammation.

The intervention would necessitate the administration of a specially devised ketogenic formula through enteral feeding. It would be a last-resort procedure for those in a critical condition.

There is currently no evidence to suggest that following a keto diet could help a healthy person prevent or treat infection with SARS-CoV-2.

However, there is evidence to suggest that keto diets can expose people to certain health risks such as by raising cholesterol levels. Keto diets may also have side effects, such as flu-like symptoms, headaches, nausea, and changes in blood pressure.

There are also claims suggesting that various herbal medicines might be able to fight off the new coronavirus.

This may partly be based on a statement issued by a Chinese official in April 2020, suggesting that certain herbal drugs could help treat COVID-19, as a communication in The Lancet on May 15, 2020, reports.

Author Yichang Yang from the Department of Traditional Chinese Medicine at the Second Affiliated Hospital of Zhejiang University School of Medicine in Hangzhou, China warns that people should take encouragements to use herbal remedies in the treatment of COVID-19 with a pinch of salt.

Yang warns that herbal remedies including the drugs that the Chinese official names can have unexpected risks and may not be as effective as some people claim. Also, evidence from human trials is very limited.

For similar reasons, he also notes that the mechanisms through which herbal drugs work on the body are often unclear, which may mean that they are not always safe.

A mystery herbal cure for COVID-19 on sale in Madagascar a herbal tea made from artemisia plants has also spurred worry among specialists, who say that the remedy may do more harm than good.

Matshidiso Moeti, director of WHO Africa, has also commented on this:

We [the WHO] would caution and advise countries against adopting a product that has not been taken through tests to see its efficacy.

Although people may be tempted to try anything and everything in the face of such a threat to health as SARS-CoV-2, the most important preventive step is to follow official national and international guidelines for public health, as well as individual health advice from doctors and other healthcare professionals.

For more information on the new coronavirus and how to stay safe during the pandemic, take a look at the information from the Centers for Disease Control and Prevention (CDC) and the WHO.

For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.

Link:
5 false claims about coronavirus remedies and why they are wrong - Medical News Today



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