Results Presented on Cleveland Clinic

Trial on Bios Life 2®

Below is the published abstract of the Cleveland Clinic Trial on Bios Life 2® that has been published in the Official Abstract Book for International Academy of Cardiology in Washington, D.C. (attended by Dr. Dennis Sprecher from Cleveland Clinic, who oversaw the study).

FIBER-MULTIVITAMIN BLEND:
AN OVER-THE-COUNTER LDL LOWERING PRODUCT

Dennis L. Sprecher MD, ¹ Gregory L. Pearce, ¹ Anita M.Boddie RD, PhD, ²
Nader Fotouhi, PhD, ² Vicki Horiatis RN¹

¹The Cleveland Clinic Foundation, Cleveland, Ohio
Rexall Sundown, Inc., Boca Raton, Florida

Before medications are approved for widespread use, they are typically tested in a controlled clinical trial. Controlled trials are considered necessary to show that a medication's effects are not subjective (relying on the patient's or physician's interpretation). Otherwise, a researcher might (perhaps unintentionally) test the medication only in patients who already show signs of responding well to treatment.

The results of the controlled, randomized, double-blind clinical trial on the Bios Life 2® that was accomplished by the Cleveland Clinic.

The abstract states that 119 patients were randomized for the trial. All of the patients were required to eat the same low fat diet for the six weeks leading up to the trial and then continue on a controlled diet throughout the trial. This isolated the variable. In other words, the patients' diet would not have been the cause of any difference in serum cholesterol as all of the patients had been following the same diet.

Ninety-nine patients completed the trial (50 on the Bios Life 2 and 49 on the placebo). Blood work was done at the fourth and the eighth week of the trial. The values obtained from the blood work were then statistically analyzed. Accepted methods of mathematical analysis can determine whether a difference in treatment outcomes is statistically significant. A statistically significant difference means that the result is very unlikely to be due to chance alone. Researchers represent the degree of certainty in a result as what is called a "p value." A p value of less than 0.05 indicates that the results of the study are statistically accurate and did not occur by chance. Achieving a significant p value is heavily dependent on the number of people in the groups that are being compared.

LDL is "Low Density Lipoprotein". A lipoprotein substance (combination of a fat and a protein) acts as a carrier for cholesterol and fats in the bloodstream. High levels of low density lipoprotein (LDL) are considered a positive risk factor for the development of coronary artery disease. Less than 130 mg/dl is desirable, 130 to 159 mg/dl is borderline high, over 160 is considered high. The results showed that there was an average difference in LDL levels of 10.3% between the groups. This is statistically significant (p<0.001) and shows the difference being solely attributable to the Bios Life 2.

Dr. Sprecher conclusion is that the Bios Life 2 was effective in the clinical trial. He even states that the Bios Life 2 should be used for primary prevention of hypercholestremia. "Triglycerides were unchanged". Even that is important as many other methods for lowering serum cholesterol may increase triglyceride levels.

The results showed an increase in HDL that was not statistically significant (p=0.54). As such, the article will represent that "HDL levels were unchanged". Again, even that is important as many other methods for lowering serum cholesterol may decrease HDL levels.

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