WEIGHT LOSS STUDY DESIGN
WEIGHT LOSS STUDY DESIGN
The three month weight loss study was conducted from May 15 through
August 15, 2006. Subjects participated in weekly body composition
measurements that included (i) body weight in pounds, (ii) body fat in
pounds and percent, (iii) lean body weight in pounds & percent,
(iv) total body water, and (v) body mass index, which scores body
weight as “normal” (BMI, 18.5 to 25), “overweight” (BMI, 25 to 30) or
“obese” (BMI, >30).
BACKGROUND
Each of the subjects that participated in the weight loss study had a history of chronic, refractory overweight and obese conditions for many years, most for more than 10 to 20 years. The majority of these subjects had tried several, if not many, fashionable diets and weight-loss medications with little success. While they were successful in losing a few pounds with each diet, they were unable to sustain weight loss due to a variety of reasons.
RESULTS OF THE 3 MONTH STUDY
Twenty four out of twenty five (24/25) subjects lost weight during the 3 month study demonstrating that 96% of subjects achieved weight loss during the Factor4 Control Study. The weight loss observed in the 24 successful subjects was 8.4 pounds on average.
RESULTS OF THE 6 MONTH STUDY
Because of the success of the 3 month study, it was decided to determine whether or not a subgroup of subjects could continue to lose weight by following the Factor4 Weight Control® regimen for an additional 3 months, making a total of 6 months. Thirteen (13) subjects signed up to continue the weight loss regimen over an additional 3 month period. Subjects continued to show steady, cumulative and persistent weight loss which demonstrated an average of 16.2 pounds of body weight lost.
RESULTS OF THE 12 MONTH STUDY
Because of the success of the 6 month study, it was decided to determine whether or not a subgroup of subjects could continue to lose weight by following the Factor4 Weight Control® regimen for an additional 6 months, making a total of 12 months. Body weight and composition measurements during this extension were taken at monthly intervals. Eleven (11) of the 13 subjects elected to continue the study. Subjects continued to show steady, cumulative and persistent weight loss success which demonstrated an average of 33.4 pounds of body weight lost. These time points represent 4.5%, 8.2% and 16% of body weight. The FDA considers a 5% reduction in body weight significant for weight loss claims.
DROPOUTS
People who dropped out of the study did so because they were generally satisfied with their weight loss goals.
SIDE EFFECTS
None of the 25 subjects complained of harmful side effects. Since the clinical weight loss study, Factor4 Weight Control® has been used on more than 700 subjects without harmful side effects. Less than 2% of patients/customers experienced mild symptoms of “gas” or “loose stools” when they first ingested Factor4. By decreasing the dose of Factor4 to 1 tspn per serving for the first week, these patients were able to fully adapt to the powder in the recommended dosages and most if not all have continued to take Factor4 without incident for several years.
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