A Randomized Double-blind Controlled Trial of Lactobacillus acidophilus Plus Bifidobacterium bifidum versus Placebo in Patients with Hypercholesterolemia.

BACKGROUND

Hypercholesterolemia is a major risk factor for cardiovascular disease. Not all patients respond well to traditional cholesterol lowering medications. Probiotics have been evaluated for their cholesterol-lowering effects in humans with variable results. This study was performed to evaluate the efficacy of two probiotics in lowering the serum cholesterol of hypercholesterolemic patients.

MATERIALS AND METHODS

A randomized double-blind controlled trial was conducted comparing placebo to Lactobacillus acidophilus plus Bifidobacterium bifidum in patients diagnosed with hypercholesterolemia. Placebo or probiotic capsules were taken three times daily for six weeks. Pre- and post-treatment total cholesterol (TC), HDL-cholesterol (HDL-C), LDL-cholesterol (LDL-C) and triglyceride (TG) levels and demographic parameters of the two groups were compared. From a total of 70 participants, 64 completed the assigned treatment (31 in probiotics group and 33 in the control group).The two treatment groups were matched for age, sex, weight, height, BMI, waist and hip circumferences, and blood pressure.

RESULTS

Baseline evaluation revealed no difference between the probiotics group and control group levels of TC, HDL-C, LDL-C and TG. TC levels in the probiotics group decreased during treatment (237.2 vs. 212.7 mg/dL, p<0.05). TC and LDL-C levels in the control group increased significantly from their baseline levels during treatment. TC (212.7 vs 252.8 mg/dL, p<0.001), HDL-C (52.0 vs 59.1 mg/dL, p=0.04) and LDL-C (153.9 vs 182.1 mg/dL, p<0.01) levels in the probiotics group were significantly lower at the end of treatment than the corresponding levels in the control group.

CONCLUSION

A combination of Lactobacillus acidophilus and Bifidobacterium bifidum decreased serum total cholesterol, LDL-cholesterol and HDL-cholesterol levels in hypercholesterolemic patients over a six week period. There was no effect on serum triglyceride or fasting blood glucose levels.