A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Cholesterol-Lowering Effect of BBR 4401 in Adults with Moderate Hypercholesterolemia

Abstract

A randomized, double-blind, placebo-controlled trial was designed to assess the efficacy of the parabiotic Bifidobacterium breve IDCC 4401, named BBR 4401, for lowering cholesterol levels. The 66 subjects (per protocol set, n = 60) with low-density lipoprotein-cholesterol (LDL-C) levels between 100 mg/dL and 150 mg/dL were enrolled after a 4-week run-in period (e.g., no probiotics, low cholesterol diet and no food affecting lipid profiles). The two groups were prescribed 1 × 1010 (low-dose) and 1 × 1011 CFU (high-dose), whereas the placebo group was prescribed 97% (w/w) of maltodextrin for 4 weeks. The compliance rates exceeded 97% in the subjects who completed the study. Comparison of the mean changes from baseline between the placebo group and test groups after the 12 weeks of BBR 4401 consumption showed a statistically significant reduction in LDL-C (up to −10.8%, p-value = 0.008) and apolipoproteinB (up to −8.1%, p-value = 0.008). Meanwhile, there were no clinically significant changes in vital signs, clinical pathology tests or electrocardiograms and no significant adverse events were reported during the study period. Concerning bowel habits, the consumption of BBR 4401 alleviated defecation strain, distension and watery feces in the high-dose group. Thus, BBR 4401 may be a safe and functional food for adults with moderate hypercholesterolemia.