(Irvine, CA)– Next Pharmaceuticals’ patented proprietary botanical ingredient Relora®, in a new double blind placebo controlled clinical trial, has been shown to help over-weight stressed individuals maintain or lower their weight. The outcome of this study has important and exciting implications for what is likely to be the new goal for Americans.
“Although it is a laudable goal to substantially reduce the number of overweight or obese Americans, this goal may be totally out of reach in the short-term. A more feasible public-health goal is to stop weight gain” says James Hill, Ph.D. Director of the Center for Human Nutrition at the University of Colorado Health Sciences Center. Dr. Hill is one of America's foremost experts in weight management. He has spent over 25 years researching the causes of weight gain, adiposity, and obesity and how to prevent or treat these problems.
“Our goal at Next is to help people get out of the craziness of the weight-gain, weight-loss, weight-gain cycle” says Bob Garrison, Jr, President and CEO of Next Pharmaceuticals. “We believe that Relora® holds great promise for a large segment of the overweight population, as well as those individuals that need to manage their stress more effectively.”
The trial was conducted by an independent clinical research organization, Miami Research Associates, under the direction of Diane R. Krieger, M.D. The forty-subjects in this pilot trial, Next’s fourth human study on Relora®, were healthy overweight, premenopausal female adults, (BMI 25 to 34.9) between the ages of 20 and 50, that typically eat more in stressful situations. While the placebo group gained significant weight during the trial, the Relora® group was able to maintain weight. Negative mood was related to weight gain in the control (placebo) group but not in the Relora® group.
Although the study was small, there were consistent trends for lowered arousal in the Relora® group as indicated by lower bedtime cortisol levels and lower systolic blood pressure. Relora® appears to promote weight maintenance and decrease stress arousal as demonstrated by decreased evening cortisol and decreased systolic blood pressure. Extensive safety data was collected demonstrating that Relora® is a safe and effective natural ingredient and may help stressed individuals maintain or lose weight.
Relora® is a proprietary formula of Magnolia officinalis and Phellodendron amurense, two botanicals with a rich history of traditional medicinal use in Asia. Next Pharmaceuticals has a patent on Magnolia, US 6,582,735, and the Phellodendron is patent-pending.
“The findings from this study are in line with our previous studies on Relora® suggesting that its benefits go beyond its primary action as a natural agent for managing stress and improving the quality of sleep” says Garrison. “This study suggests that individuals who are stress eaters and who also have elevated cortisol levels, might have greater success in managing their weight by supplementing with Relora® in addition to watching their calories and maintaining a regular exercise program. We intend to continue studying Relora® and are currently planning for a larger clinical trial. ”
Relora® may play a role in decreasing the risks associated with the stress/cortisol-related condition known as metabolic syndrome. According to the Centers for Disease Control and Prevention (CDC), as many as 47 million Americans may suffer from metabolic syndrome, which is characterized by a cluster of conditions including insulin resistance and the presence of obesity, abdominal fat, high blood sugar and triglycerides, high blood cholesterol, and high blood pressure.
“Dietary supplement manufacturers and functional food/beverage companies have a myriad of new product positioning opportunities with the addition of our patented ingredient Relora®,” says Garrison. “Our three human studies along with the findings from our current clinical trial with Relora® provide branding opportunities in some hot markets, including stress reduction and weight control.”
Next Pharmaceuticals, Inc. is a research and development company that markets its patented or patent-pending ingredients such as Relora®, Nexrutine®, and Seditol™ to food, beverage, and dietary supplement companies focused on health enhancement and disease prevention.