• 3 Clinical Trials Support Use of Innovative Portion-Control Supplement for Weight- Loss

11/28/10

(Tampa, FL) – A team of scientists and physicians have announced the results from a series of three clinical trials that evaluated a novel portion-control dietary supplement called PREE® which was found to be safe and effective for weight loss. Three multi-center prospective studies tested PREE in 105 overweight adults. A meta-analysis of the three trials showed that daily use of PREE provided an average weight loss of 13.5 lbs over 8 weeks without unpleasant side effects.

PREE is the brainchild of Wellosophy® Corporation, a Tampa Bay area healthy lifestyles company which has been marketing PREE since 2007. Wellosophy’s CEO, Lior Sher stated: “We don’t believe in diets. Diets don’t work. The only way to lose weight permanently is to change your lifestyle; which is exactly what PREE was designed to accomplish. Losing weight too quickly usually sets you up to gain the weight back quickly as well. The secret to long term success is to lose weight slowly and naturally by changing your eating habits, reducing your portions, making healthy food choices and exercising. We believe that PREE is a major scientific advance. It is in a category by itself, and is the only product of its kind to demonstrate this level of efficacy without side effects.”

PREE is a portion-control product that allows people to eat less without feeling hungry so they can lose weight comfortably without feeling deprived. Richard Davis, MD, Wellosophy’s Chief Medical Officer, said: “Medical carbomers like PREE have been in wide commercial use for decades in items like bulking and thickening agents, food additives, pharmaceuticals and many other FDA-approved products. PREE is the first product of its kind and defines an entirely new category of ingestible portion-control dietary supplements. PREE contains no calories, no stimulants, or preservatives and is designed to act like natural cellulose fibers that expand in the stomach, only much more powerfully. PREE triggers our physiologic satiety mechanisms which makes you feel full before meals, so you eat less – naturally. In addition, PREE’s patent-pending formula includes Leucine, which is a natural amino acid that is known to enhance muscle mass and increase fatty acid metabolism which support weight management objectives.”

PREE’s three clinical studies were conducted in physician-managed weight loss clinics and hospital-based weight management programs. The independent clinical investigators reported that PREE was free of side-effects and was effective in comfortably reducing meal portions by 33% to 50% in 95% of participants tested.

Each 500mg PREE capsule is composed of thousands of tiny pH-optimized microbeads that are activated by water which expand hundreds of times their size to form small soft gels about 1mm in size in the stomach. Two capsules taken 30-60 minutes prior to meals with about 16 oz of water gently expand to a total volume about the size of a Big Mac® so people feel full as they sit down to eat. The expanded microbeads typically remain in the stomach for up to 3 hours; so the feeling of fullness is prolonged.

PREE is entirely bioinert and is not digested or absorbed. It gently creates bulk in the stomach, then passes through the gastrointestinal tract and is eliminated naturally like corn, lentils and other non-digestible foods. Most gastric bulking agents on the market today are derived from natural cellulose-based fibers, plant gum products or extracts. These are less than ideal since they only expand 20 to 60 times, can vary in quality from batch to batch, may cause allergic reactions in sensitive users, and are often subject to bacterial attack and spoilage, requiring the addition of antibacterials. PREE, on the other hand, is an excellent gastric bulking agent. It expands up to 1,000 times its size, is pharmaceutically pure, is consistent from batch to batch, does not support bacterial growth, is hypo-allergenic, and does not cause bloating, gas, diarrhea or constipation, and is widely reported to improve bowel regularity.

Wellosophy is currently planning additional studies in teens and diabetics.