Studies .....................................................................................................................................................................................................

Open Human Trials

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 reported restful sleep.

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.

Relora® prevents weight gain.

Clinical Trial 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.