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).
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.
People who dropped out of the study did so because they were generally satisfied with their weight loss goals.
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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FINAL RESULTS OF THE WEIGHT LOSS STUDY
Based on weekly measurements of body weight as well as body composition (percent body fat, fat pounds, lean body mass, total body water and body mass index) in a group of 25 overweight and obese adults (9 males and 16 females), the following positive effects were observed:
REPRESENTATIVE WEIGHT LOSS GRAPHS
NovaLife Nutrition conducted a 24 week weight loss study in Canyon Lake, CA, to assess the effectiveness of Factor4 Weight Control™ in causing weight loss in a group of women and men who suffered from chronic refractory overweight disorders and obesity over the past 10-20 years. Twenty four (24) out of twenty five (25) subjects lost significant amounts of weight, indicating a 96% success rate. Note that subjects were not required to engage in an exercise routine or adhere to a strict dietary regimen. The graphs below represent body weight measurements in 8 subjects that lost between 15 and 30 pounds. Weight loss performance may be further accelerated by combining Factor4 Weight Control™ with modest restrictions in food intake and modest engagements in exercise routines. Under these conditions individuals may lose up to 1 pound of weight every two days.
WEIGHT LOSS STUDY FEEDBACK
Why Does Factor4 Weight Control™ Work When Other Weight Loss Diets and Medications Do Not?
COMPLIANCE WITH FEDERAL REGULATIONS
On December 1, 2009 the FTC’s Regulatory and Enforcement Authority under Section 5 of the Federal Trade Commission Act (FTCA) issued revised guidelines concerning the use of endorsements and testimonials in advertisements for dietary supplements. In the spirit of full disclosure mandated by the FTC’s Revised Guides on truth in advertising, NovaLife Inc. submits the following detailed information related to the design and execution of its Factor4 weight loss study conducted in 2006-2007.
This information includes the results of the study at 3 months, 6 months and 12 months and provides adequate and reliable substantiations for the claims and testimonials posted on this website. The company believes that the testimonials and endorser’s experiences are typical for users of Factor4 Weight Control™. While the results are presented as average values for the respective groups, individual results may vary in accordance with biological variations observed in relatively small study groups.
This information is submitted in an attempt to control unfair or deceptive advertising in commerce and to promote transparency in communication with existing and potential customers.
NEXT STEPS IN FTC COMPLIANCE
NovaLife, under Dr. Scheele’s leadership, intends to conduct double-blind, placebo-controlled clinical trials of Factor4 health products using unbiased Contract Research Organizations (CROs) in the near future.
Disclaimer :This product is not meant to diagnose, treat, cure, or prevent any disease by the use of pharmaceutical drugs. As a dietary supplement, with all natural ingredients, considered to be “generally regarded as safe” (GRAS), Factor4 is intended only to improve health and wellness in the organs and tissues throughout the body. Comments and notations, derived from testimonials and limited human studies, have not been evaluated by the FDA. All results stated in this white paper and on our website(s) are actual results from real customers or individuals included in our clinical trials. Individual results may vary depending on personal goals and use.