Medical Professional FAQs

 

 

FAQs – Immune Health

Where do products with Wellmune fit in the context of other immune support functional foods and beverages like probiotics and prebiotics?

Unlike probiotics which have been linked to improved gut health without a well understood mechanism of action, products with Wellmune provide a systemic benefit to the immune system and have a well-defined mechanism of action.

Once swallowed, immune cells in the gastrointestinal tract take up Wellmune and transport it to immune organs throughout the body. While in the immune organs, immune cells called macrophages digest Wellmune into smaller fragments and slowly release them over a number of days. The fragments bind to neutrophils, via complement receptor 3 (CR3), which account for 60-70% of all immune cells.

Is better immune function measurable?

Yes. There are nine clinical studies measuring changes in immune function as a result of Wellmune intake.

What are the differences between various beta glucans?

There are significant differences between beta glucans derived from cereals, yeast and fungi. Even among yeast beta glucans, which have the most potent immune support properties, research shows that slight differences in molecular structure can affect biological activity and the resulting health benefits. In fact, research demonstrating these differences was published in Blood. The citation is  Qi, C., Y. Cai, L. Gunn, C. Ding, B. Li, G. Kloecker, K. Qian, J. Vasilakos, S. Saijo, Y. Iwakura, J. R. Yannelli and J. Yan (2011). “Differential pathways regulating innate and adaptive antitumor immune responses by particulate and soluble yeast-derived β-glucans.” Blood 117(25): 6825-6836

Is there a billing code for discussing immune health?

Individuals will need to inquire with their insurer.

 

FAQs – Sports Nutrition

Is Wellmune part of the NSF Certified for Sport Program?

Biothera is currently testing a Wellmune WGP bulk powder product called Sports Performance Edge.  NSF certification is not needed for Wellmune for when added to shakes, smoothies and other beverages as a food ingredient. However, the NSF  certification application process is underway so that Wellmune WGP can be consumed in dietary supplement products. Check back here for a status update.

When and how should Wellmune be taken?

Wellmune may be taken at any time of day whether on its own in supplement form or as part of a meal or snack to deliver its everyday immune health benefits.

Does supplementation with Wellmune WGP improve mucosal immunity?

Dr. Brian McFarlin has conducted two research studies with Wellmune WGP and results found that Wellmune improves mucosal immunity. Click here for a short video from Dr. McFarlin on this topic.

Which athletes are the best candidates for Wellmune supplementation?

Our peer-reviewed, published research has been conducted on marathon runners and recreationally active, fit adults subjected to significant physical stress.  The researchers extrapolate these benefits to a healthy adult population. Future clinical studies will explore the benefits for those with more sedentary lifestyles.

Why is Wellmune recommended during the off season?

Wellmune WGP is designed for everyday use year-round. The immune health needs of athletes don’t need to take a break even if their training regimen shifts to an off-season schedule.

Have any studies been conducted among recreational athletes?

Yes. We have done a number of studies with marathon runners and have conducted one study among recreational athletes taking a look at immune suppression associated with strenuous exercise. This was a randomized, double-blinded, placebo-controlled study involving 60 recreational athletes who took either a placebo or 250 mg of Wellmune daily for 10 days. The athletes then rode an exercise bike for one hour in a laboratory heat stress chamber. The study indicated that Wellmune may enable both recreational and elite athletes to exercise longer and harder with less risk of immune suppression that normally follows high-intensity exercise. For more on the study methodology and findings click here.

Is Wellmune beneficial even if an athlete is already taking Vitamin C?

Yes. Vitamin C supports a range of health benefits while Wellmune WGP specifically supports the immune system and has a known mechanism of action to do so. Additionally, there are no known interactions or contraindications with Wellmune used in combination with other ingredients in a food or dietary supplement.

What are the recovery benefits of Wellmune?

An exercise stress study at the University of Houston found that Wellmune may enable both recreational and elite athletes to exercise longer and harder with less risk of immune system suppression that normally follows high-intensity exercise.  The effectiveness of the immune system drops sharply below its normal state two to six hours after strenuous exercise and then gradually recovers within 24 hours. During this “open window” period, athletes are more susceptible to infection, which may result in lost training time. Study participants had higher levels of key cytokines following Lipopolysaccharide stimulation when taking Wellmune. LPS is derived from gram-negative bacteria and used to mimic a foreign challenge to stimulate an immune response.

What specifically were the findings about URTI benefits?

Several studies have looked at the impact of Wellmune on URTI symptoms on high-stress populations. Specific to athletes, in the “Austin Marathon” clinical study, Wellmune supplementation significantly reduced (by more than 34%) the number of days that subjects reported both general health problems and cold/flu symptoms. Previous studies conducted by the University of Houston also showed that immune suppression associated with strenuous exercise reduced with Wellmune. It is reasonable to speculate that the improvements with Wellmune in the Austin Marathon study were likely due to alterations in monocytes, plasma cytokines and improved mucosal immunity. 

Is there a preferred delivery method for athletes? Has there been research?

Any form of Wellmune at the recommended serving 250 mg per day – whether in food, beverages or supplements – will deliver the immune health support effectively. Most research on Wellmune is done using dietary supplements containing only Wellmune.

Can Wellmune help modulate inflammation?

The research to date suggests that Wellmune is of benefit to controlling inflammation. That is a topic for future research.

Is Wellmune safe for children who play sports?

Yes. Wellmune is safe for everyone regardless of activity level.

 

FAQs – Safety

Are there any known drug or food interactions with Wellmune?

Wellmune WGP has a strong safety and toxicity profile and is approved as a safe novel food ingredient by leading regulatory agencies worldwide.

Are products with Wellmune designed for use during cold/flu season?

Products with Wellmune are designed for everyday consumption year-round, including during cold/flu season.

Is Wellmune safe for pregnant and nursing mothers?

Wellmune WGP has a strong safety profile. There are many safety and toxicology studies completed that demonstrate safety. We have demonstrated that the product is safe in numerous human clinical studies. Documents submitted to the U.S. Food and Drug Administration for use of Wellmune WGP in foods have a long history of safe product use by consumers. Nonetheless, Biothera recommends that pregnant and nursing mothers consult with their physician before taking any nutritional supplement.

Is Wellmune safe for specific health conditions or for those receiving specific medical treatment?

There are no known interactions or contraindications with Wellmune used in combination with other ingredients in a food or dietary supplement.

Is Wellmune safe for:

People with diabetes? Are there carbohydrate grams?
A typical dose of Wellmune is 250 mg of which 244 mg are dietary fiber, with no sugars or starch.

People undergoing chemotherapy?
People undergoing chemotherapy are under significant stress. Wellmune enhances immunity and may be beneficial. Individuals should consult with their physician before taking any nutritional supplement.

People undergoing radiation?
People undergoing radiation are under significant stress. Wellmune enhances immunity and may be beneficial. Individuals should consult with their physician before taking any nutritional supplement.

People with cardiovascular disease?
Individuals should consult with their physician before taking any nutritional supplement.

People with ulcers?
Individuals should consult with their physician before taking any nutritional supplement.

People with autoimmune diseases?
Biothera has not conducted studies of our product with specific autoimmune disease subjects. We recommend that any person with an autoimmune disease discuss the use of Wellmune WGP with their medical care provider prior to use.

People with celiac disease?
People with celiac disease are advised to maintain a gluten-free diet. Gluten is a protein found in certain cereals. It is very different than glucan, which is a carbohydrate.

People with Crohn’s disease?
Individuals should consult with their physician before taking any nutritional supplement.

People with irritable bowel syndrome?
Individuals should consult with their physician before taking any nutritional supplement.

People who have had organ transplants?
Biothera does not have any data on the use of Wellmune in transplant patients. All of our research has been done with healthy normal adults. We recommend that transplant patients consult with their physicians before taking any dietary supplements.

Are there any age, weight or other restrictions?

No. Wellmune WGP is appropriate throughout the lifecycle and is used in products for people of all ages.

Is Wellmune appropriate for the elderly?

Yes. Wellmune WGP is appropriate throughout the lifecycle and is used in products for people of all ages.

Is there any research on Wellmune specific to children?

Currently, effective levels of Wellmune for children are based on common and accepted methods that extrapolate adult intakes of vitamins and minerals to child intakes. Studies conducted with Wellmune have used normal healthy subjects with a normal weight distribution.

Are there any contraindications for Wellmune?

Wellmune is a nutritional ingredient that is safe for daily consumption and is Generally Recognized as Safe (GRAS) under U.S. FDA regulations. Its safety and clinical data has been published in peer reviewed clinical journals and reviewed by the FDA.

 

FAQs – Wellmune WGP

How long after consuming Wellmune does it begin to work?

Wellmune begins to provide immune support within 1-2 days after it is consumed.

Wellmune must be uptaken by specific cells in the small intestine; these cells are in the Peyer’s patches and are called M cells. Shortly after taking Wellmune it moves into the small intestine to be uptaken by M cells. The M cells transfer the Wellmune to white blood cells called macrophage cells. The macrophage cells slowly digest Wellmune over a period of days. The earliest protection is likely to begin 1-2 days after consuming Wellmune as the macrophage cell digests the Wellmune and releases the biologically active form of Wellmune to another white blood cell called a neutrophil.

What is the recommended serving size?

Adults
The effective serving size of Wellmune was determined in pre-clinical and human clinical studies. It is determined that 2.5 mg of Wellmune per kg of body weight provides the desired health benefit.

Children age 6 and up
The effective serving size of Wellmune was determined in pre-clinical and human clinical studies. It is determined that 2.5 mg of Wellmune per kg of body weight provides the desired health benefit.

Children under age 6
For young children, based on an extrapolation of efficacious adult intakes, the total daily intake of Wellmune for children less than 6 years of age is estimated to be 25 mg/day to 75 mg/day.

Morbidly obese individuals
The recommended serving size is based upon body weight (see above). Following this guideline will help ensure the right amount of Wellmune for any individual regardless of weight.

 

How many calories are in a serving?

The estimated caloric value is 0 kcal per 250 mg of Wellmune.

Is there a recommended time to day to take Wellmune?

Products with Wellmune may be taken at any time of day.

Should Wellmune be taken with food or without food?

Wellmune is an ingredient in many foods and supplements. Consequently, consumers can select their preference of Wellmune in food products, beverages, supplements or any combination.

Is there a minimum and maximum serving per day to be efficacious?

The effective serving size of Wellmune was determined in pre-clinical and human clinical studies. It is determined that 2.5 mg of Wellmune per kg of body weight provides the desired health benefit. While there is no maximum dose, exceeding the 2.5 mg per kg of body weight provides no additional benefit.

Is Wellmune available for sale on grocery store shelves?

Yes, products with Wellmune are available in a range of food, mass market and specialty food stores. A number of products are conveniently available online. This link highlights offerings in the Wellmune product family.

How can I try products with Wellmune?

Click on this link for products currently containing Wellmune. We will also be sampling select products with Wellmune at our booth, #1207, at the Food and Nutrition Conference and Expo (FNCE) 2012.

Are products with Wellmune covered under WIC programs?

Specific products that contain Wellmune may be covered by WIC programs, but there is no specific coverage for Wellmune.

What is the shelf life for Wellmune?

Wellmune in its bulk form delivered to manufacturers has a shelf life of at least five years. Since Wellmune is an inert ingredient, it does not react with other ingredients contained in the food product consumed by end users. Consumers should refer to the shelf life of the product containing Wellmune, and can be confident that they will receive the appropriate immune support from Wellmune as an ingredient.

What is the proper way to store Wellmune?

Consumers should follow the food product’s packaging label for information on proper storage of food products containing Wellmune.

 

Does Wellmune lose its effectiveness if the product is frozen, cooked/baked or otherwise exposed to temperature extremes?

Wellmune has strong heat and temperature stability and will not be affected by temperature extremes or temperature swings.

Will Wellmune be effective if I use it after the expiration date?

Most food and beverage products have an expiration date of 2-3 years. Wellmune’s shelf life of 5 years surpasses that. Consumers should follow the food or beverage product’s expiration date.

How do I read the expiration date if it’s not apparent in the way it’s printed on the package?

Contact the manufacturer of the product that contains Wellmune if you have questions about the expiration date.

Do capsules need to be swallowed? Can they be chewed?

Consumers should follow the supplement maker’s instructions about how to take the capsule. The way someone ingests Wellmune will not change its effectiveness.

 

Should Wellmune be taken with water?

Consumers should follow the supplement maker’s directions for use.