Low dose red yeast rice with monacolin K lowers LDL cholesterol and blood pressure in Japanese with mild dyslipidemia: A multicenter, randomized trial.

2021-09-01
Asia Pacific journal of clinical nutrition 30(3)
- Takuya Minamizuka
- Masaya Koshizaka
- Mayumi Shoji
- Masaya Yamaga
- Aiko Hayashi
- Kana Ide
- Shintaro Ide
- Takumi Kitamoto
- Kenichi Sakamoto
- Akiko Hattori
- Takahiro Ishikawa
- Junji Kobayashi
- Yoshiro Maezawa
- Kazuki Kobayashi
- Minoru Takemoto
- Masaru Inagaki
- Akira Endo
- Koutaro Yokote

PubMed: 34587702
DOI: 10.6133/apjcn.202109_30(3).0009

Study Design

Type: Randomized Controlled Trial (RCT)
Population: 18 patients without known cardiovascular disease and unsatisfactory low-density lipoprotein cholesterol controlled only by diet therapy
Methods: randomly allocated to receive low dose red yeast rice (200 mg/day) containing 2 mg monacolin K or diet therapy alone for 8 weeks
Duration: 8 weeks

Background and objectives

Red yeast rice contains monacolin K, an inhibitor of cholesterol synthesis, and gamma-aminobutyric acid, a neurotransmitter. The daily dose of red yeast rice and monacolin K in previous studies was relatively high; therefore, there were safety concerns. We aimed to examine the effects of low daily dose red yeast rice on arteriosclerosis in patients with mild dyslipidemia.

Methods and study design

Eighteen patients without known cardiovascular disease and unsatisfactory low-density lipoprotein cholesterol (3.96±0.19 mmol/L) controlled only by diet therapy were randomly allocated to receive low dose red yeast rice (200 mg/day) containing 2 mg monacolin K or diet therapy alone for 8 weeks. The primary outcome was the absolute change in low-density lipoprotein cholesterol. Secondary outcomes included total cholesterol, apolipoprotein B, and blood pressure.

Results

Low-density lipoprotein cholesterol decreased significantly in the red yeast rice group than in the diet therapy group (median -0.20 [-0.62, 1.19] mmol/L vs. red yeast rice -0.96 [-1.05, -0.34] mmol/L, p=0.030). The red yeast rice group also exhibited significant decreases in total cholesterol, apolipoprotein B, and blood pressure. No severe treatment-related adverse effects on muscles, liver, or renal function were observed.

Conclusions

We found that patients in the red yeast rice group exhibited significant reductions in lowdensity lipoprotein cholesterol, total cholesterol, apolipoprotein B, and blood pressure without any recognised adverse effect. This suggests that low daily dose red yeast rice could reduce cardiovascular risk in patients with dyslipidemia.

Research Insights

red yeast rice→Reduced Apolipoprotein B Levels
The red yeast rice group also exhibited significant decreases in total cholesterol, apolipoprotein B, and blood pressure.
Effect
Beneficial
Effect size
Moderate
Dose
200 mg/day
red yeast rice→Reduced Blood Cholesterol
The red yeast rice group also exhibited significant decreases in total cholesterol, apolipoprotein B, and blood pressure.
Effect
Beneficial
Effect size
Moderate
Dose
200 mg/day
red yeast rice→Reduced Blood Pressure
The red yeast rice group also exhibited significant decreases in total cholesterol, apolipoprotein B, and blood pressure.
Effect
Beneficial
Effect size
Moderate
Dose
200 mg/day
red yeast rice→Reduced Low-Density Lipoprotein Level
Low-density lipoprotein cholesterol decreased significantly in the red yeast rice group than in the diet therapy group (median [interquartile range]: control -0.20 [-0.62, 1.19] mmol/L vs. red yeast rice -0.96 [-1.05, -0.34] mmol/L, p=0.030).
Effect
Beneficial
Effect size
Moderate
Dose
200 mg/day

Adverse Events Reported

red yeast rice→Overall tolerability
No severe treatment-related adverse effects on muscles, liver, or renal function were observed.
Finding
Reported