Fiber-multivitamin combination therapy: a beneficial influence on low-density lipoprotein and homocysteine.

Proven effective alternative and adjunctive therapies for lipid lowering could be beneficial for patients with hyperlipidemia. We evaluated a 90% soluble fiber for its ability to alter lipid, lipoprotein, and homocysteine levels in the setting of coadministered folate and B vitamins. Patients (n = 119) were randomized to either the fiber and vitamin combination, or placebo. Fasting lipid, glucose, and homocysteine concentrations, and body mass index (BMI) were obtained at baseline and weeks 4 and 8. Both between-group (Wilcoxon rank-sum test) and within-group (paired t test) comparisons were used to evaluate treatment effects. After 6 weeks of a diet therapy (National Cholesterol Education Program [NECP] Step I) run-in period, subjects in both groups had similar low-density lipoprotein cholesterol (LDL-C) levels (159 mg/dL v 158 mg/dL). The treated group showed a 7.1% +/- 11.6% reduction by 4 weeks, which was maintained at 8 weeks (7.9% +/- 11.0%). Placebo patients had a slight increase in LDL-C values over the same period (+2.4% +/- 11.7%), for a 10.3% difference between groups. The treatment effect was statistically significant both between groups (P <.001) and within the active-treatment group (P <.001) after the 8-week intervention. Apolipoprotein B (ApoB) levels in a representative subset of the treated group (n = 53) decreased by 20% (P =.004). The fiber blend neither raised triacylglycerol (TG) (P =.95) nor lowered high-density lipoprotein cholesterol (HDL-C) levels (P =.54), and lowered homocysteine (active, 9.8 to 8.7/micromol/L, P =.02; placebo, 9.4 to 9.2 /micromol/L, P =.98). Thus, a significant LDL-C lowering effect, with parallel Apo B reduction, was demonstrated for this fiber/vitamin combination. No adverse changes on TG or HDL-C levels were noted, and folate/B vitamin benefits attributed to homocysteine reduction were preserved. Concurrent administration of fiber and vitamins represents a preventive approach that may reduce the need for concomitant lipid-lowering therapies or serve as an adjunct therapy. Copyright 2002, Elsevier Science (USA). All rights reserved.

RCT Entities:   Population Interventions Outcomes