TY - JOUR

T1 - Low daily dose of 3 mg monacolin K from RYR reduces the concentration of LDL-C in a randomized, placebo-controlled intervention

AU - Heinz, Tina

AU - Schuchardt, Jan Philipp

AU - Möller, Katharina

AU - Hadji, Peyman

AU - Hahn, Andreas

N1 - Funding information: First of all, we thank the participants who contributed their time to this project. The study was partly supported by Madaus GmbH, Köln, Germany (now a part of MEDA Pharma, Bad Homburg, Germany). The authors are solely responsible for the design and conduct of the study, collection, management, analysis, and interpretation of the data, as well as preparation of the manuscript. All authors had full access to the data and take responsibility for its integrity. All authors have read and agreed with the manuscript as written. There was no conflict of interest for all authors.

PY - 2016/10/1

Y1 - 2016/10/1

N2 - Hypercholesterolemia and elevated homocysteine concentrations are associated with cardiovascular risk. Previous studies have demonstrated a cholesterol-lowering effect of red yeast rice (RYR) supplements which contained 5 to 10 mg of monacolin K. We hypothesized that the intake of a low monacolin K dose may likewise reduce low-density lipoprotein–cholesterol (LDL-C) and other plasma lipids. In secondary analyses, we tested the homocysteine lowering effect of folic acid, which was also included in the study preparation. Therefore, we conducted a randomized, double-blind, and placebo-controlled intervention study. One hundred forty-two nonstatin-treated participants with hypercholesterolemia (LDL-C ≥ 4.14 ≤ 5.69 mmol/L) were randomized to the supplement group with RYR or the placebo group. Participants of the supplement group consumed 3 mg monacolin K and 200 μg folic acid per day. A significant (P < .001) reduction of LDL-C (−14.8%), total cholesterol (−11.2%), and homocysteine (−12.5%) was determined in the supplement group after 12 weeks. A total of 51% of the participants treated with RYR achieved the limit of LDL-C <4.14 mmol/L advised and 26% reached the threshold level of homocysteine <10 μmol/L. No significant changes were exhibited within the placebo group. Other parameters remained unchanged and no intolerances or serious adverse events were observed. In conclusion, we demonstrated that a low dose of daily 3 mg monacolin K from RYR reduces the concentration of LDL-C; a risk factor for cardiovascular diseases.

AB - Hypercholesterolemia and elevated homocysteine concentrations are associated with cardiovascular risk. Previous studies have demonstrated a cholesterol-lowering effect of red yeast rice (RYR) supplements which contained 5 to 10 mg of monacolin K. We hypothesized that the intake of a low monacolin K dose may likewise reduce low-density lipoprotein–cholesterol (LDL-C) and other plasma lipids. In secondary analyses, we tested the homocysteine lowering effect of folic acid, which was also included in the study preparation. Therefore, we conducted a randomized, double-blind, and placebo-controlled intervention study. One hundred forty-two nonstatin-treated participants with hypercholesterolemia (LDL-C ≥ 4.14 ≤ 5.69 mmol/L) were randomized to the supplement group with RYR or the placebo group. Participants of the supplement group consumed 3 mg monacolin K and 200 μg folic acid per day. A significant (P < .001) reduction of LDL-C (−14.8%), total cholesterol (−11.2%), and homocysteine (−12.5%) was determined in the supplement group after 12 weeks. A total of 51% of the participants treated with RYR achieved the limit of LDL-C <4.14 mmol/L advised and 26% reached the threshold level of homocysteine <10 μmol/L. No significant changes were exhibited within the placebo group. Other parameters remained unchanged and no intolerances or serious adverse events were observed. In conclusion, we demonstrated that a low dose of daily 3 mg monacolin K from RYR reduces the concentration of LDL-C; a risk factor for cardiovascular diseases.

KW - Folic acid

KW - Homocysteine

KW - LDL-cholesterol

KW - Monacolin K

KW - Red yeast rice

UR - http://www.scopus.com/inward/record.url?scp=84992187045&partnerID=8YFLogxK

U2 - 10.1016/j.nutres.2016.07.005

DO - 10.1016/j.nutres.2016.07.005

M3 - Article

C2 - 27865358

AN - SCOPUS:84992187045

VL - 36

SP - 1162

EP - 1170

JO - Nutrition research

JF - Nutrition research

SN - 0271-5317

IS - 10

ER -