Wellmune

By Major General (ret) John Parker, M.D.
Biothera Healthcare Scientific Advisory Board

As a physician and recreational sports enthusiast, I was excited to see the results of the latest clinical study results on Wellmune WGP presented at the American College of Sports Medicine. As noted in an earlier blog, the study was conducted by sports medicine researchers at the University of Houston’s Health and Human Performance Lab, a state-of-the-art facility with some of the world’s leading researchers committed to understanding and optimizing sports performance.

The presentation of these results is yet another important milestone for the safety and efficacy of Wellmune WGP. In this double-blinded study of 96 men and 86 women who competed in the Austin, Texas, LiveStrong Marathon in 2011, there were measurable results. During the course of the four weeks marathoners took Wellmune, they experienced a 40% reduction in upper respiratory tract infection symptoms compared to the control group.

A key reason I joined Biothera’s Scientific Advisory Board a decade ago was directly related to the commitment to clinical research in support any claim made by Biothera. . The company’s commitment to integrity, sound science and credibility continues and is laudable; in my experience it is a rarity in the world of supplement claims.

It is impressive to see the consistency with which the early study results and the safety profile are corroborated among new research subjects and in a broadened profile of individuals under physical and emotional stress. I believe the insight into Wellmune’s mechanism of action is significant and the reason behind these consistent results.

The research continues to support my personal conviction that the human body has the capability to resist disease. In terms of the immune system, we should do everything we can to augment and support the body’s natural defenses. I like the simple analogy that Wellmune supports the neutrophils to launch an accelerated “Pac-Man” style assault against foreign invaders. In the broader context of addressing today’s global public health crisis, we need all of the Pac-Men we can get.

 Dr. Parker is a former Assistant Surgeon General of the U.S. Army, Commanding General of largest Department of Defense Medical Research Activity, and current Senior Vice President and Chief Medical Officer of Science Applications International Corporation (SAIC).

EAGAN, Minn., June 7, 2012 – A panel of experts from regulatory, scientific and industry vantage points will present their perspectives on the scientific evidence required to substantiate an immune health claim during the 2012 Institute of Food Technologists (IFT) Annual Meeting and Expo in Las Vegas on Wednesday, June 27. The session will examine both why it is difficult to develop credible science to support claims that are compelling to consumers and acceptable to regulatory agencies and potential solutions.

“Substantiating an Immune Health Claim: Three Perspectives” will feature the following speakers and topics:

• “Substantiating Immune Health Claims: Perspectives of Scientific/Regulatory Authorities in North America and Europe” —Lina Paulionis, M.Sc., MHSc, RD, senior scientific and regulatory consultant, Intertek Cantox’s Food and Nutrition Group.
• “Challenges in Defining Appropriate Immune Function Biomarkers” —Simin Nikbin Meydani, D.V.M, Ph.D., director of the Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University.
• “Designing a Claim Substantiation Research Program: An Industry Perspective” —Don Cox, Ph.D., senior vice president, Research & Development, Healthcare Group, Biothera.

“Finding the right combination of credible science to support claims and to meet the needs of stakeholders from regulatory agencies through product development and manufacturing to consumers is a significant challenge, especially given the complexity of the immune system and the rapidly evolving regulatory framework,” said Dr. Cox. “This session will illuminate key challenges from a global perspective in developing the scientific data to support a commercially viable and meaningful claim and provide best practices in claims substantiation.”

Two members of Biothera’s Healthcare R&D group are involved with this IFT symposium.  Biothera’s flagship immune health ingredient, Wellmune WGP^®, has earned broad regulatory approval as an immune health ingredient for foods, beverages and supplements. The clinically proven immune health benefits of Wellmune WGP have won accolades from the food and beverage industry including a prestigious IFT Innovation Award in 2007.

The session is from 10:35-11:35 a.m. in Room N117 at the Las Vegas Convention Center. For more information stop by the Biothera booth, #1829.

About Wellmune WGP^®

Wellmune WGP is a natural beta 1,3/1,6 gluco polysaccharide that is clinically proven to prime key immune cells that keep the body healthy. This unique food, beverage and supplement ingredient has regulatory approval around the world, including GRAS status in the U.S. and novel foods approval in Europe and China.  It is also patented, Kosher, Halal, non-allergenic and GMO-free. In addition to receiving an IFT Innovation Award, Wellmune has received a SupplySide West Scientific Excellence Award and a Frost & Sullivan Excellence in Research Award. Wellmune WGP is a product of Biothera, a U.S. biotechnology company dedicated to improving immune health.

 Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606 (direct)

651-675-0300 (main)

dwalsh@biothera.com

Clinical Research presented at the American College of Sports Medicine

SAN FRANCISCO — May 30, 2012 — Marathoners taking Wellmune WGP^®, a natural immune health ingredient, for four weeks reported 40% more healthy days than other long-distance runners, according to new clinical study results presented today at the American College of Sports Medicine 59^th annual meeting.

It is common for runners to develop upper respiratory tract infections (URTI) in the days and weeks following completion of a marathon. Based on previous physical stress studies with Wellmune WGP that indicated links between specific biomarkers and improved health, researchers believed that marathoners would benefit from enhanced immune function.

Clinical Study Results
The double-blinded study involved 182 runners who completed the 2011 LiveStrong Marathon in Austin, Texas.  The participants included 96 men and 86 women with an average age of 34 and an average finish time of 4:00 hours.  Participants were given either 250 mg/day of Wellmune soluble, Wellmune dispersible, or a rice flour placebo to take for four weeks following the marathon.

Subjects taking Wellmune soluble experienced a 45% reduction in the number of days that they reported both general health problems and URTI symptoms while subjects consuming Wellmune dispersible reported 34% fewer days of URTI symptoms, for an average reduction of 40%.  These results were statistically significant compared to placebo (p<0.05).

“The study confirms previous clinical research showing that Wellmune WGP’s support of the immune system has real health benefits for individuals under physical stress,” said Rich Mueller, chief executive officer of Biothera, the manufacturer of Wellmune WGP.  “This applies to both elite athletes as well as recreational athletes.”

In previous physical stress studies conducted by the University Houston, health improvements in participants taking Wellmune were associated with alterations in monocytes, plasma cytokines, and improved mucosal immunity.

“Wellmune is the first ingredient we’ve tested that showed measurable improvements in key immune system biomarkers,” said study leader Brian McFarlin, Ph.D., FACSM, Associate Professor of Exercise Physiology, Nutrition, and Immunology in the Department of Health and Human Performance at the University of Houston.

The poster presentation is entitled, “Baker’s Yeast Beta Glucan Supplementation Reduces the Number of Cold/Flu Symptomatic Days After Completing a Marathon.”   Authors are James A. Navalta of Western Kentucky University, Bowling Green, KY, and Katie C. Carpenter, Whitney L. Breslin, Tiffany Davidson, Brian K. McFarlin of University of Houston, Houston, TX.

About Wellmune WGP^®

Wellmune WGP is a natural beta 1,3/1,6 glucan that is clinically proven to boost key immune cells that keep the body healthy. This unique food, beverage and supplement ingredient has regulatory approval around the world, including GRAS status in the U.S. and novel foods approval in Europe and China.  It is also patented, Kosher, Halal, non-allergenic and GMO-free. In addition to receiving an IFT Innovation Award, Wellmune has received a SupplySide West Scientific Excellence Award and a Frost & Sullivan Excellence in Research Award. Wellmune WGP is a product of Biothera, a U.S. biotechnology company dedicated to improving immune health.

Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606 (direct)

651-675-0300 (main)

dwalsh@biothera.com

Clinical research published in the British Journal of Nutrition

EAGAN, MN — May 21, 2012 — Wellmune WGP^®, a natural immune health ingredient for foods, beverages and supplements, prevented suppression of the immune system that normally occurs after intense exercise, according to a new clinical study published online in the British Journal of Nutrition.

These results, along with similar physical stress clinical studies, demonstrate that Wellmune WGP may help recreational and elite athletes achieve training and performance goals by minimizing “down time” associated with immune suppression.

“In contrast to the placebo group, athletes taking Wellmune had a higher degree of immune support before and after exercise, as measured by monocyte concentrations and enhanced cytokine production during a simulated immune challenge,” said Brian McFarlin, Ph.D., FACSM, Associate Professor of Exercise Physiology, Nutrition, and Immunology in the Department of Health and Human Performance at the University of Houston.

Wellmune WGP is a beta 1,3/1,6 gluco polysaccharide that boosts key innate immune cells that help keep the body healthy.  Specifically, Wellmune activates neutrophils, the most abundant population of immune cells in the body. It also enhances certain chemical messengers that help coordinate the body’s immune defenses.

Study Design

The randomized, double-blinded, placebo-controlled study involved 60 recreational athletes [31 women (age 22 +5), 29 men (age 23 +5)] engaged in sustained aerobic exercise. Following initial screening, study subjects were given either a placebo or 250 mg of Wellmune WGP daily for 10 days.

At the end of the supplementation period, the athletes rode an exercise bicycle for approximately 50-min in a heat stress chamber set at 38C (100F) and 45% relative humidity to create an environment that placed the athletes under physiological and psychological stress.  Blood samples were drawn at day 0 and immediately before and after the exercise session and again two hours post exercise. Twenty-five different aspects of immune health were analyzed.

Using a cross-over study design, the athletes next observed a seven-day “wash out” period during which no supplement was given to clear their bodies of any supplement effect. The study subjects then repeated the 10-day supplementation with the other test variable (Wellmune or placebo).  At the end of the second supplementation period, the subjects then replicated their initial exercise regimen.

Study Results

Study subjects taking Wellmune WGP had statistically significant higher concentrations of monocytes in their blood compared with the blood samples while taking the placebo.  The higher monocyte level was recorded immediately before and after exercise, as well as two hours post exercise.

Study participants also had higher levels of key cytokines (IL-2, IL-4, IL-5 and IFN-gamma) following a 24-h Lipopolysaccharide (LPS) stimulation when taking Wellmune WGP.  LPS is derived from gram-negative bacteria and used to mimic a foreign challenge to stimulate an immune response.  The data also showed higher levels of plasma cytokines (IL-4, IL-5, IL-7, IL-8, IL-10, and IFN-gamma) two hours after exercise when the subjects had supplemented with Wellmune.  All of these results were statistically significant (p<0.05).

The research was conducted under the direction of Dr. McFarlin at the Health and Human Performance Lab, University of Houston.  The paper, “Baker’s yeast β-glucan supplementation increases monocytes and cytokines post-exercise: implications for infection risk?” was published online ahead of print in the British Journal of Nutrition.  Authors: K. C. Carpenter, W. L. Breslin, T. Davidson, A. Adams and B. K. McFarlin.  Abstract.

About Wellmune WGP^®

Wellmune WGP is a natural beta 1,3/1,6 gluco polysaccharide that is clinically proven to boost key immune cells that help maintain health, wellness and vitality. This unique ingredient is found in more than 35 countries in food, beverage and supplement products, including juices, smoothies, toddler formula, soups, breads, beverage shots and sachets, and functional chocolates, cookies and snack bars.

Wellmune has regulatory approval around the world, including GRAS status in the U.S. and novel foods approval in Europe and China.  It is also patented, Kosher, Halal, non-allergenic and GMO-free.

In addition to receiving an IFT Innovation Award, Wellmune has received a SupplySide West Scientific Excellence Award and a Frost & Sullivan Excellence in Research Award. Wellmune WGP is a product of Biothera, a U.S. biotechnology company dedicated to improving immune health.

Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606 (direct)

651-675-0300 (main)

dwalsh@biothera.com

You might want to think twice the next time you pay cash for a burger or giant pretzel, then use your hands to pop a bite into your mouth. Because your mom was right: our money really is full of disgusting germs.

Think about it: anything that gets onto our hands can get onto our money. Kids stuff their shoes with money. We pick up coins from dirty parking lots. Sick people handle money all the time. There can be millions of germs on money at any given point. Germs cling to paper money more easily than coins, and the older the bill, the more germs it probably carries.

Various studies over the years have found fecal bacteria and other common germs such as Staphylococcus aureus on U.S. currency. According to the Federal Reserve, the average bill lasts just 16 months before it is too soiled to use and is removed from circulation.

Since the late 1990s, some Japanese banks have taken ‘money laundering’ to a whole new level with ‘clean ATM’ machines. Customers insert their yen into the machine, where it is sanitized using high heat, then returned to the customers. Of course, once someone touches the money again, it becomes contaminated.

It’s reassuring to know that most bacteria die on surfaces within hours unless they have the right growing conditions. But while experts say your risk of contracting a serious infection from dirty money isn’t very high, there could be enough germs on your cash to transmit a cold virus. Or if heavily soiled money comes into contact with an open sore, you might get an infection. Again, not likely, but possible. Plus, there’s simply that ‘yuck’ factor of not knowing what kinds of germs you’re touching.

Bottom line: play it safe by always washing your hands after handling money, and especially before touching your eyes, nose or mouth.