A new study at the University of Miami using Rice Bran Arabinoxylan Compound (RBAC) and sponsored by Daiwa Health Development, the Los Angeles-based subsidiary of Daiwa Pharmaceutical Co. Ltd. in Tokyo, Japan, will assess the efficacy of RBAC intervention on Natural Killer (NK) cell activity and determine if a 3 gram per day condition is superior to a 1 gram per day condition on the effect on NK cell activity. In previous Daiwa studies, Rice Bran Arabinoxylan Compound (RBAC) has been clinically shown to triple NK cell activity, increase T and B lymphocytes and demonstrate vital antioxidant and anti-inflammatory action.

The 60-day, 20-subject clinical study, under the direction of John E. Lewis, Ph.D., research assistant professor at the Department of Psychiatry and Behavioral Sciences at the University of Miami, Miller School of Medicine, will have five assessment points:
• Immune Functioning:
NK Cell activity at baseline, 48 hours, 1 week, 1 month, and 2 months and cytokines activity at baseline, 1 month, and 2 months.
• Liver and Kidney Functioning:
Total bilirubin, creatinine, and liver function tests at baseline, 48 hours, 1 week, 1 month, and 2 months.
• Physiological and Anthropometric Measurements:
Blood pressure and heart rate, body weight and height to calculate body mass index (BMI), skinfold caliper assessment to calculate percent body fat, waist and hip circumference to calculate waist to hip ratio at baseline and 2 months.
• Physical Activity:
Physical activity will be assessed at baseline and 2 months follow-up by the Stanford 7-day activity recall. This instrument assesses the amount (number of hours) of moderate, physically challenging, and very physically challenging activities over the past 7 days. This instrument provides useful estimates of habitual physical activity for research, significantly agrees with daily self-report of physical activity, and has been validated for use in community settings.
• Functional Health and Well-Being:
The SF-36v2™ Health Survey provides psychometrically-based physical and mental health summary measures and a preference-based health utility index. It is a generic measure that does not target a specific age, disease, or treatment group and will be assessed at baseline and 2 months follow-up.

“Over the course of these five assessment points we are looking at the primary outcome of natural killer cell activity,” said Dr. Lewis. “We are also studying cytokine activity and have a battery of 12 different cytokines that we are reviewing,” added Dr. Lewis.

Cytokines are proteins that are secreted by the different cells in the immune system and are markers of inflammation.

“Inflammation is a big buzz word these days,” said Dr. Lewis. “Numerous published studies have shown how inflammation affects the body. If we can show that within a 60-day trial of RBAC that we had a positive effect on cytokines, some being pro, some being anti-inflammatory, this research would become extremely valuable,” says Dr. Lewis.

RBAC, a polysaccharide dietary fiber derived from rice bran, is modified by a Shiitake mushroom enzyme using a patented biotechnology process.

“In addition to boosting natural killer cell activity, we believe this novel study using RBAC in our BRM4® formulation may show it has the ability to either reduce the pro-inflammatory cytokines or raise the anti-inflammatory cytokines, or possibly do both,” said Ron Marzoli, vice president, Daiwa Health Development.

As an immune modulator, BRM4® retains its effectiveness over time. Clinical trials have shown BRM4® is safe with no side effects. In over 12 years of worldwide use, there have been no reported cases of drug interactions. BRM4™ is recognized as the gold standard immune product worldwide for people with seriously compromised immune systems.

“We feel so strongly about the valuable health benefits of RBAC that we felt it was important to raise greater awareness of the health benefits and substantiate the credibility factor in terms of product marketability in North America that we proposed conducting a study and selected the University of Miami,” added Marzoli.

BRM4® in a 250mg dosage, 60-count bottle, has been available through physicians in the US for over 10 years. In pre-clinical studies, the power of BRM4® multiplies T cell levels up to 200%. The enhanced activity of helper T cells promotes the proliferation of cytotoxic T and B cells for essential immune support. Helper T cells also signal plasma B cells when they encounter their cognate antigen to secure a health production of antibodies. Furthermore, BRM4™ supports the body’s natural production of cytokines to control inflammatory response. Daiwa Health Development introduced a double strength BRM4®, a 500mg, 60-count version of its patented immune enhancing complex to the health professional marketplace in 2009. For more study and product information call 877.434.3633 or email [email protected].

Daiwa Pharmaceutical and Daiwa Health Development have become a leading research and manufacturing company, striving to create new value in the field of bioscience. Daiwa focuses on the manufacturing and distribution of nutraceuticals, functional foods and cosmetics.