Mechanism of Action
Relora is an exciting new natural anti-anxiety/stress relief ingredient to control stress-related eating and drinking that has the added value of being non-sedating with potential anti-depressant properties. In central nervous system receptor binding assays, the plant extracts in Relora bind to several important targets associated with anxiety. It does not bind to the benzodiazepine receptors that would cause sedation, yet has the relaxing qualities of the benzodiazepine class of drugs in a validated anxiolytic animal model. In addition, it normalizes hormone levels associated with stress-induced obesity and eating/drinking behavior.

Stress is being shown to play a significant role in a wide variety of conditions and disease states. Recent work from the National Institute of Health (NIH) and other major research centers has demonstrated that stress is a significant contributor to immune dysfunction, cardiovascular disease, other age-related disorders, and to excess body fat. Over 20% of adults have an obesity-like condition characterized by an excessive amount of abdominal fat. This condition is related to stress-induced hormone imbalances, especially imbalances of cortisol and DHEA. Until now, the only course of action for loosing this fat has been stress reduction with exercise and diet. Relora can normalize cortisol and DHEA levels in stressed individuals, induce relaxation, and act as an aid in controlling weight and stress-related eating or drinking.

Human Trials
The first formulation of Relora was tested and found to be a safe, effective, rapid acting, non-sedating dietary supplement that helps control occasional mild anxiety. Fifty subjects were treated with Relora for two weeks. The recommended dosage was 200 mg of Relora three times daily. (The new and improved Relora dosage is 250 mg three times daily.) Based on pre-clinical studies, Relora was designed and evaluated against the following concepts; "Relora helps control occasional mild anxiety or mild depression and the associated symptoms: 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. Though the product does not cause significant sedation, 74% of the patients had a restful sleep. No significant side effects were reported. When subjects were asked about drowsiness, only 24% reported that they were drowsy. Relora was judged to be gentle on the stomach by 94% of the subjects. A second trial was undertaken to measure cortisol and DHEA levels in 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%). These significant findings support Relora’s ability to relieve stress and its potential role in weight control and stress-related eating and drinking behavior. A clinical trial on the final formulation of Relora is expected to be complete in 2002.

Animal Model
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." This model has been validated for the benzodiazepine class of anti-anxiety drugs. The excellent results of the patent-pending extracts in Relora using this model were published in Psychopharmacology (2001) 153:219-234.

Safety Studies
An extensive literature review of the chemical constituents along with the parent plants’ use for hundreds of years indicates that this material is safe for its intended use. An acute toxicity study in rats (5g/kg) with 14-day observation revealed no untoward effects of the individual extracts or the combination in Relora except mild diarrhea and slight sedation in female rats. No side effects are expected at the recommended human dosage.