ArtJen Clinical Trial Ahead Of FDA Curve With All Natural, Patented FBCx Weight Loss Product
February 22, 2007 (PRLEAP.COM) Health NewsArtJen Complexus Holdings Corp. is pleased to announce that the results of the first clinical trial of the fat fighter FBCx were published in January in the peer reviewed scientific medical journal Diabetes/Metabolism Research and Reviews, and that the design of this trial was in agreement with the February 2007 FDA recommendations for weight management products.
The manuscript entitled, "The Benefits of Early Intervention in Obese Diabetic Patients with FBCx™ - A New Dietary Fiber" is co-authored by Dr. George Grunberger of the Grunberger Diabetes Institute, Bloomfield Hills, MI and ArtJen President and Vice President Drs. K-L Catherine Jen and Joseph Artiss, Windsor, ON. Dr. Artiss is quoted as saying that, “After having our clinical trial design criticized by many in the field, we feel vindicated that the FDA has published recommendations that mirror our work.” Dr. Jen adds that contrary to every other “diet pill” study that she is aware of, “It just made sense to us that if you are going to study a weight loss product, you have to involve those people who most need to lose weight and in a real world setting.”
The co-inventors of FBCx are Associate Professor of Pathology Joseph Artiss, Ph.D., FACB and K-L Catherine Jen, Ph.D., Professor and Chair of Nutrition and Food Science, both of Wayne State University in Detroit, MI. “I have spent my entire career studying obesity, and FBCx works where most others have failed to live up to their hype”, said Dr. Jen.
Following publication of the FBCx clinical trial data on obese type 2 diabetics, the FDA published recommendations for the evaluation of weight loss products that require studies to be double-blind, placebo controlled with applicable lifestyle changes for obese (BMI>30) volunteers with other complications such as type 2 diabetes. This is exactly the study that was designed by ArtJen eighteen months earlier. The impressive highlights of this trial include:
- Significant (adjusted) weight loss amongst all participants in the active group
- Decreases in serum triglyceride levels of more than 20% within two months
- Decreases in blood LDL cholesterol of up to 20% within three months
Subjects in pre-clinical trials, including non-diabetic patients showed dramatic, consistent weight loss with significant decreases in their blood cholesterol and triglyceride levels. Many consumers have reported noticeable weight loss within the first few weeks and over 60 pounds of total weight loss, without changes to their lifestyle or diet.
ArtJen Complexus Holdings Corp. is the sole manufacturer of FBCx tablets, an all-natural, patented, dietary fiber. FBCx has the very unique ability to bind nine times its own weight in dietary fat, essentially preventing 80 calories from being absorbed per tablet. Taken as directed, two tablets of FBCx per fat-containing meal are capable of removing about 25-30% of the calories from a typical North American diet. This facilitates a safe rate of decrease in body weight of about 1-1½ pounds per week.