Effects of heat killed Lactiplantibacillus plantarum N1487-7 intake in humans with impaired liver function: A randomized, double-blind, placebo-controlled, parallel-group study

Abstract

Background: The liver is an organ that performs important functions such as nutrient synthesis and detoxification, and liver health is greatly affected by lifestyle habits. Inappropriate lifestyle habits such as overeating, excessive alcohol intake, and lack of exercise cause inflammation in the liver. Serum levels of liver function markers such as aspartate aminotransferase and low-density lipoprotein cholesterol (LDL-c) increase as liver function declines. Recently, it has been suggested that heat-sterilized Lactiplantibacillus plantarum N1487-7 (N1487-7-HK) have an anti-inflammatory effect, and this effect may be useful in supporting liver function.

Objective: To investigate the effect of oral intake of N1487-7-HK on liver function in healthy subjects with elevated serum levels of liver function markers.

Methods: A randomized, double-blind, placebo-controlled, parallel-group comparative study was conducted. One hundred subjects (20–64 years old) were randomly assigned to receive N1487-7-HK (6 × 1010 cells/capsule/day) or a placebo, ingested once daily for 12 weeks. Efficacy endpoints included the serum levels of four liver function markers and of interleukin (IL)-10; safety endpoints included serum levels of LDL-c and total cholesterol (TC).

Results: There were no significant differences in serum levels of liver function markers or of IL-10 between the two groups. In safety evaluations, the LDL-c level change (p = 0.049 at Week 12) and the TC level changes (p = 0.047 at Week 6, p = 0.012 at Week 12) show a significantly greater reduction (improvement) in the N1487-7-HK group than in the placebo group. Notably, in a subgroup analysis of subjects with baseline serum TC levels below the median (228.5 mg/dL), serum IL-10 levels at study completion were significantly higher in the N1487-7-HK intake group than in the placebo group (p = 0.003 at Week 12).

Conclusions: These results suggested that N1487-7-HK ingestion has an anti-inflammatory effect and improves LDL-c and TC metabolism in subjects with impaired liver function. Therefore, N1487-7-HK supplementation may be effective in preventing or improving arteriosclerosis, myocardial infarction, cerebral infarction, and cholelithiasis.

Trial registration number: UMIN000051940.

Keywords: Lactiplantibacillus plantarum, liver function, interleukin-10, low density lipoprotein cholesterol, total cholesterol