Relora® is an exciting new natural anti-anxiety and stress relief ingredient used to control stress-related eating and drinking that has the added value of being non-sedating with potential anti-depressant properties.

Human Open Trial results show:

• 8 out of 10 people felt more relaxed.
  
• 7 out of 10 people enjoyed more restful sleep.
  
• 9 out of 10 people said it (Relora®) was gentle on the stomach.
  

STRESS AND FAT

Chronic stress can cause cravings for cookies, candy, chips and other high-fat, high-carbohydrate foods. The stress-driven appetite for these foods leads to dangerous weight gain, primarily around the waist. Sixty percent (60%) of American adults are overweight or obese, much of which is due to stress-related food cravings. Over twenty percent (20%) of American adults are obese with a stress-related condition known as "metabolic syndrome." This condition is characterized by a “beer belly”, high blood pressure, poor cholesterol readings and high blood sugar.

According to Dr. Pamela Peeke, a former scientist at the National Institutes of Health and associate clinical professor of medicine at the University of Maryland School of Medicine, people with an apple-shaped figure are at greater risk for heart disease, stroke, diabetes, and some types of cancer. "It's not just what you weigh; it's where you weigh it," says Dr. Peeke, author of Fight Fat After Forty (Viking).

Until recently there were few known predictors of stress-induced eating. While most adults who have sugar and/or fat cravings under stress are aware of their out-of-control appetite, scientists have had difficulty in demonstrating actual cause and effect. Dr. Elissa Epel and colleagues at the University of California, San Francisco have now clearly shown that individuals who are high reactors to the stress hormone called cortisol, consume more calories and more sweet foods under stress. Their recent study also demonstrated that greater food consumption occurred in high cortisol reactors when they were in a negative mood.

Relora®, a natural dietary supplement developed by Next Pharmaceuticals, Inc. in Irvine California, was developed to improve mood, help stressed individuals relax, and to normalize the hormones related to stress-induced eating. Eighty percent (80%) of stressed adults studied feel more relaxed with Relora®. Relora® has also been shown in a pilot study to normalize cortisol levels in stressed individuals. Preliminary findings suggest that Relora® can decrease the cravings for high fat, high sugar foods in stressed individuals, most likely due to its ability to normalize stress hormone levels that cause these cravings.

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STRESS RELATED WEIGHT CONTROL

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 has been 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 twenty percent (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 (50) subjects were treated with Relora® for two weeks. The recommended dosage was 200mg of Relora®three times daily. (The new and improved Relora dosage is 250mg 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 including irritability, emotional ups and downs, restlessness, tense muscles, poor sleep and 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.

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