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The Cleveland Clinic Study
Bios Life 2® 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
2Rexall Sundown,
Inc., Boca Raton, Florida
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.
Patients
(n= 119) were randomized to either a fiber-blend treatment or placebo with 99 participants
(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.
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% +/- 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.
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.