BACKGROUND & AIMS: A dietary supplement containing garlic fermented with Monascus pilosus (MGFE) may be useful to decrease the lipid concentrations in serum without serious adverse effects. The aim of the study was to assess whether MGFE decreases serum lipid contents in volunteers with mild hyperlipidemia in a randomized, double-blind, placebo-controlled, parallel-group trial. METHODS:Healthy subjects (n = 55) with serum triglyceride concentrations of 120-200mg/dL were randomly assigned to take either MGFE or placebo capsules for 12 wk. RESULTS: A borderline, but not significant effect, to decrease triglyceride concentrations in serum (approximately 15% reduction at maximum, P = 0.062, in time × treatment interaction effect) was observed by the MGFE intake for 12 wk. The decreased reading exhibited a significant difference at wk-8 between the MGFE and placebo groups (unpaired t test, P = 0.007). The total cholesterol (P = 0.003) and LDL cholesterol (P = 0.001) contents in the serum and the LDL/HDL ratio (P < 0.001) were significant in time × treatment interaction effects by the MGFE intake. However, no alteration in the body fat percentage and abdominal circumference was observed. CONCLUSIONS: The intake of MGFE decreased triglyceride and cholesterol in serum with no appreciable adverse effects in normal to mildly hyperlipidemic individuals, suggesting that it may be effective to improve and prevent the metabolic syndrome. This clinical trial was registered with Clinicaltrials.gov as NCT00938249.
RCT Entities:
BACKGROUND & AIMS: A dietary supplement containing garlic fermented with Monascus pilosus (MGFE) may be useful to decrease the lipid concentrations in serum without serious adverse effects. The aim of the study was to assess whether MGFE decreases serum lipid contents in volunteers with mild hyperlipidemia in a randomized, double-blind, placebo-controlled, parallel-group trial. METHODS: Healthy subjects (n = 55) with serum triglyceride concentrations of 120-200mg/dL were randomly assigned to take either MGFE or placebo capsules for 12 wk. RESULTS: A borderline, but not significant effect, to decrease triglyceride concentrations in serum (approximately 15% reduction at maximum, P = 0.062, in time × treatment interaction effect) was observed by the MGFE intake for 12 wk. The decreased reading exhibited a significant difference at wk-8 between the MGFE and placebo groups (unpaired t test, P = 0.007). The total cholesterol (P = 0.003) and LDL cholesterol (P = 0.001) contents in the serum and the LDL/HDL ratio (P < 0.001) were significant in time × treatment interaction effects by the MGFE intake. However, no alteration in the body fat percentage and abdominal circumference was observed. CONCLUSIONS: The intake of MGFE decreased triglyceride and cholesterol in serum with no appreciable adverse effects in normal to mildly hyperlipidemic individuals, suggesting that it may be effective to improve and prevent the metabolic syndrome. This clinical trial was registered with Clinicaltrials.gov as NCT00938249.
Authors: Tatiana V Kirichenko; Vasily N Sukhorukov; Alexander M Markin; Nikita G Nikiforov; Ping-Yen Liu; Igor A Sobenin; Vadim V Tarasov; Alexander N Orekhov; Gjumrakch Aliev Journal: Front Pharmacol Date: 2020-04-08 Impact factor: 5.810