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