Factor4™ Weight Loss Study
WEIGHT LOSS STUDY DESIGN
WEIGHT LOSS STUDY DESIGNThe 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.
LEARN MORE:
- Read the letter that Susan Perkins, one of the subjects who participated in the 12 month study, wrote which described, in detail, her history of weight loss efforts using diets and weight-loss drugs over a period of 25 to 30 years.
- See the results of a focus group discussion among weight loss subjects following the study.
- See the detailed graph of weight loss observed in the eleven (11) subjects that completed the full 12 month clinical study.
- See the results of individual testimonials, some with “before” and “after” pictures, that were submitted by subjects associated with the weight loss study financed by the company.
- A copy of the manuscript describing the details of the Factor4 weight loss study is available on request at gscheele@san.rr.com.
- Obtain Dr. Scheele’s recent eBook, “The Obesity Cure” at http://www.atlasbooks.com/theobesitycure/
- Obtain Dr. Scheele’s paperback book, ”The Obesity Cure,” by clicking here
- Obtain Dr. Scheele’s paperback book, ”The Obesity Cure Primer,” by clicking here
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:
- The results of the 3 month study showed that 96% of subjects (24 out of 25 subjects) who followed the Factor4 Weight Loss regimen over that period of time lost weight.
- The results of the six month study on 13 subjects indicated that subjects continued to lose significant additional weight during the second 3 month period.
- Weight loss performance fell into three groups: (i) modest weight loss (1-9 pounds; n = 13 subjects), (ii) moderate weight loss (10-19 pounds; n = 6 subjects) and (iii) large-scale weight loss (20-29 pounds; n = 5 subjects).
- Body Mass Index decreased in all subjects measured.
- Weight loss occurred in the absence of forced dietary changes and increased exercise.
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?
After the Weight Loss study was completed NovaLife Nutrition conducted a Focus Group with the subjects that participated in the study to determine why Factor4 Weight Control™ worked in these subjects when other weight loss diets and weight loss medications had not worked in the past. The comments of the participants in the Focus Group are shown here.
SUMMARY COMMENTS
- Factor4 is easy, tasty, versatile, pleasurable, painless and fun
- Factor4 shakes are healthy, guilt-free and painless
- Factor4 is the ultimate solution for weight loss and weight control
- Factor4 is the only ™life-long solution™ for weight control
- Factor4 is satisfying in every respect for losing weight and sustaining weight control
WHY FACTOR4 WORKS
- Factor4 leads to significant weight loss and sustained weight control
- Factor4 increases intake of Power Amino Acids™, Super-Plus Proteins™, minerals, vitamins, fiber and FOS
- Drink Factor4 shakes with water before meals (3-4 times per day)
- Large Factor4 smoothies at breakfast curb appetites at lunch
- Factor4 may be used as meal replacements
- Factor4 increases water intake
- Factor4 makes you conscious of the weight-loss program
- Factor4 has no unwanted side effects
FACTOR4 SUPPRESSES APPETTITE
- Factor4 allows you to reduce food intake by half without the loss of pleasures in taste and gastronomy
- Factor4 naturally decreases eating frequency
- Factor4 naturally improves portion control
- Factor4 satisfies appetite
- Factor4 stops food cravings, including snacks and fast foods
- Factor4 curbs food cravings and hunger pangs
- Factor4 leads to appetite suppression
FACTOR4 IS VERSATILE
- Factor4 is versatile, not regimented
- Factor4 is versatile and therefore highly beneficial in a large variety of liquid recipes
- Factor4 is versatile with a large variety of power shakes, smoothies, snacks, desserts and meal replacements which are tasty and satisfying
EASE OF USING FACTOR4
- Factor4 is the easiest, most satisfying approach to losing weight with the best results I have obtained to date
- The amazing thing is I don't feel deprived or depressed because I am on a diet, yet again for the umpteenth time
FACTOR4 IS DELICIOUS
- Factor4 shakes and smoothies taste yummy, yet add very few calories to the diet
- Factor4 is tasty and pleasurable in the mouth, throat and stomach (swirling, swallowing and ingestion, respectively)
- Factor4 has no aftertaste, like protein supplements
- Factor4 does not taste like medicine
QUALITY OF FOOD SELECTION
- Factor4 naturally leads to better choices in food
- Factor4 naturally shifts taste to higher value foods
- Factor4 leads to a natural transition from low-quality food to high-quality food
- Factor4 reduces desire for low-value foods with fat, salt and sugar
- Factor4 abolishes mid-afternoon lows and post-carb crashes
ADDITIONAL BENEFITS
- Factor4 promotes nutritional health
- Factor4 promotes youth and longevity
- Factor4 promotes health in the 8 major health systems in the body
- Factor4 assists in fighting addictions and dependence disorders
- Feel better in up to 50 different ways with Factor4
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.