Relora^® is a natural proprietary blend of a patented (U.S. Patent No. US 6,582,735) extract of Magnolia officinalis and a proprietary extract from Phellodendron amurense. Relora^® was developed as an ingredient for dietary supplements and functional foods that could be used in stress management and for

stress-related appetite control. This patented blend of plant extracts is the result of screening more than fifty plant fractions from traditional plant medicines used around the world. Relora^® has excellent stress management properties without causing sedation.

Relora^® is a natural stress management ingredient that helps control stress-related eating and has the added value of being non-sedating. In central nervous system receptor binding assays the plant extracts in Relora^® binds to several important targets associated with stress. It does not bind to the benzodiazepine receptors that would cause sedation, yet has the relaxing qualities that have been demonstrated in both animal and

human studies. In addition, it normalizes hormone levels associated with stress-induced weight gain and eating behavior. Stress has been shown to play a significant role in a variety of conditions. A large percentage of overweight adults have excessive abdominal fat due to stress-related over eating. Relora^® appears to maintain healthy hormone levels in stressed individuals and act as an aid in controlling weight and stress-related eating.

The plant extracts in Relora^® have been shown to be an effective non-sedating anti-stress product in an animal model known as the "Chick Social Separation Stress

Procedure." The excellent results of the patent-pending extracts in Relora^® using this model were published in Psychopharmacology (2001)153:219-234.

The first formulation of Relora^® was tested and found to be a safe, effective, and rapid acting, dietary supplement that helps control stress symptoms. Fifty subjects were treated with Relora^® for two weeks. The recommended dosage was 200mg Relora^® three times daily. (The new Relora^® dosage is 750 mg daily in divided doses.) Based on pre-clinical studies, Relora^® was designed and evaluated against the following concepts; Relora^® helps control stress-related symptoms, such as: irritability; emotional ups and downs; restlessness; tense muscles; poor sleep; concentration difficulties. Post trial analysis revealed an excellent agreement (82%) with the pretrial concept. Relaxation was reported by 78% of the patients. The product does not cause significant sedation, however, 74% of the patients did

report restful sleep. Only 24% reported drowsiness. Relora^® was judged to be gentle on the stomach by 94% of the subjects. No significant side effects were reported. A second trial was undertaken to measure cortisol and DHEA levels in 12 patients with mild to moderate stress. Elevated cortisol levels and depressed DHEA levels are associated with chronic stress. A two-week regimen of Relora^® caused a significant (P= 0.003) increase in salivary DHEA (227%) and a significant (P = 0.01) decrease in morning salivary cortisol levels (37%). Cortisol and DHEA levels were returned to normal in all subjects during the course of Relora^®. A third trial of 49 subjects achieved similar results to the first trial regarding relaxation and restful sleep.

In addition, Relora^® reduced stress-related snacking of sweets, such as ice cream, cake, pie, and cookies by 76% in those individuals that claimed they ate these types of foods under stress.

Over 1,200 subjects at the Living Longer Clinic in Cincinnati have taken Relora^® and rated its efficacy on a 5-point scale. Relora^® was considered effective for stress, restful sleep and stress related eating if the subject rated the product 3 or higher. Ninety-one percent (91%) of the subjects reported Relora^® helped them relax with a mean score of 3.5. Ninety percent (90%) reported Relora^® helped them have a restful sleep with a mean score of 3.6. Eighty-six percent (86%) reported Relora^® helped prevent stress related eating with a mean score of 3.5. Seventy-two percent (72%) of the subjects rated Relora^® as effective in helping manage weight with a mean score of 3.1.

A double-blind placebo-controlled clinical trial with Relora^® was completed in January 2004. The purpose of this study was to determine the effects of Relora^® in overweight women who typically eat more in stressful situations. Twenty-eight subjects completed the study and Relora^® was well tolerated. There was a significant weight gain during the study for the placebo group but no significant weight gain and some weight loss for the Relora^® group. There was also a significant reduction in anxiety scores. The mechanism of action appears to be through reduction or normalization of stress hormone levels, and possibly perceived stress, thereby helping subjects maintain body weight.