Background and aims: There is increasing interest in the use of natural therapies to reduce elevated low density lipoprotein (LDL) cholesterol. This study assessed the effects of PCC Lactobacillus fermentum on LDL cholesterol and other lipid fractions.
Methods and results: This was a single centre, double blind, placebo-controlled, parallel design trial in volunteers having total cholesterol > or =4 mmol/L. Subjects (n=46) were randomised to receive either Lactobacillus fermentum 2 capsules twice daily (each capsule containing 2 x 10(9) colony forming units) or matching placebo for a period of 10 weeks. Main outcome measures were percentage changes in LDL cholesterol and other lipids, changes in liver enzymes and other safety tests. Two subjects withdrew early in the study, 1 for personal reasons and 1 because of bowel discomfort. Three other subjects experienced some bowel discomfort but still completed the study. LDL cholesterol showed a modest downward trend on both Lactobacillus fermentum and placebo of 7.0% and 5.2% respectively. This trend did not reach statistical significance over time, nor was there a significant difference between the treatment arms. There were no significant changes over time or between treatments noted in total cholesterol, high density lipoprotein cholesterol or triglycerides. There were no significant changes in liver enzymes or other safety parameters with time or between treatments.
Conclusion: Lactobacillus fermentum did not appear to produce a major change in serum lipid fractions, but a small effect cannot be excluded.