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

2Rexall Sundown, Inc., Boca Raton, Florida

Background: A commonly used 90% soluble fiber-blend product (Bios Life 2) has not been evaluated for lipid altering effect. Few data are available to describe the influence of fiber on serum ApoB levels. Further, as a fiber-vitamin combination agent, the potential claim of folate/B6 benefit in the setting of fiber intake has not been examined.

Methods: Patients (n=119) were randomized to either a fiber blend treatment, or placebo with 99 (50 treatment, 49 placebo) completing the study. Fasting lipid profiles (including ApoB), and homocysteine concentrations were obtained at weeks 4 and 8. Between group (Wilcoxon rank-sums test) and within group (paired t-tests) comparisons were used to evaluate treatment effect.

Results: Subjects in both groups showed similar baseline LDL levels (159mg/dl vs. 158mg/dl). The treatment group showed a 7.9% +/- 11.0 reduction (p<0.001) over 8 weeks. Placebo patients showed a slight increase in LDL over the same period (+2.4% +/- 11.7, p=0.16), for a 10.3% difference between groups (p<0.001). ApoB measured in a subset (n=53) revealed a 20% reduction with treatment (p=0.004). Treatment subjects showed a reduction in homocysteine (9.8 mg/dl to 8.7 mg/dl, p=0.02), while neither TG (p=0.95) nor HDL-c (p=0.54) changed.

Conclusions: Significant LDL and ApoB lowering effects are demonstrated. No adverse effects on triglyceride or HDL-c levels were noted, and folate/B vitamin derived benefits towards homocysteine reduction were preserved. This combination product could be used to reduce the need for concomitant lipid lowering prescription therapy, as well as for advancing self-styled primary prevention strategies.

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