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The short-term supplementation of monacolin K improves the lipid and metabolic patterns of hypertensive and hypercholesterolemic subjects at low cardiovascular risk.

Food & function
January 1, 1970
Alberto Mazza et al. (6 authors)
Journal ArticleRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to investigate the efficacy and safety of a nutraceutical containing high doses of monacolin K (10 mg) from red yeast rice in improving lipid profiles and glucose metabolism in hypertensive and hypercholesterolemic subjects.

Results Summary

The study found that the nutraceutical significantly reduced total cholesterol, LDL cholesterol, triglycerides, and blood glucose compared to diet alone, with no changes in HDL cholesterol. The treatment was well-tolerated and effective.

Population

Thirty subjects with grade-1 essential hypertension and hypercholesterolemia at low cardiovascular risk (mean age 51.5 ± 7.8 years, 62.9% males).

Effective Dosage

10 mg monacolin K daily (one tablet per day).

Duration

1 month.

Interactions

None mentioned.

Extracted Claims (10)
InterventionDirectionEndpointPopulationDosageImpactClaim #
nutraceutical compounds (NCs) containing red yeast rice extracts providing a daily dose of 2.5-10 mg of monacolin K
decrease
cholesterol levels
-
-
hypocholesterolemic effect
#1
NC containing high doses of monacolin K (10 mg) added to the diet
increase
lipid profile and glucose metabolism
hypertensive and hyper-cholesterolemic subjects at low cardiovascular risk
-
improving the lipid profile and glucose metabolism
#2
programmed diet
decrease
serum total cholesterol (TC), triglycerides (TG) and low-density-lipoprotein cholesterol (LDLC)
subjects with grade-1 essential hypertension
-
significant reduction
#3
NC containing red yeast rice, policosanols, resveratrol and chromium picolinate
decrease
serum total cholesterol (TC), triglycerides (TG) and low-density-lipoprotein cholesterol (LDLC)
subjects with grade-1 essential hypertension
-
significant reduction
#4
NC containing red yeast rice, policosanols, resveratrol and chromium picolinate
decrease
total cholesterol (TC)
treatment group
9.19%
reduction was significantly greater
#5
NC containing red yeast rice, policosanols, resveratrol and chromium picolinate
decrease
low-density-lipoprotein cholesterol (LDLC)
treatment group
12.29%
reduction was significantly greater
#6
NC containing red yeast rice, policosanols, resveratrol and chromium picolinate
decrease
blood glucose
treatment group
4.28%
significant higher reduction
#7
programmed diet
no change
high-density-lipoprotein cholesterol (HDLC) levels
both groups
-
remained unchanged
#8
NC containing red yeast rice, policosanols, resveratrol and chromium picolinate
no change
high-density-lipoprotein cholesterol (HDLC) levels
both groups
-
remained unchanged
#9
NC containing high doses of monacolin K
increase
lipid and glucose patterns
-
-
appeared to be safe, well tolerated and effective
#10
Abstract

Background - The clinical hypocholesterolemic effect of nutraceutical compounds (NCs) containing red yeast rice extracts providing a daily dose of 2.5-10 mg of monacolin K is now well established. For this reason, NCs may be a viable alternative to the statin drugs commonly used to lower cholesterol levels. However, in order to avoid some possible statin-like side effects, most NCs available on the market contain low doses of monacolin K, which could reduce their efficacy. The aim of this study was to investigate the efficacy and safety of a NC containing high doses of monacolin K (10 mg) in improving the lipid profile and glucose metabolism when added to the diet versus the diet alone in a group of hypertensive and hyper-cholesterolemic subjects at low cardiovascular risk. Methods - Thirty subjects with grade-1 essential hypertension (mean age 51.5 ± 7.8 years, 62.9% males) were enrolled in the treatment group (NC group). These subjects followed a programmed diet and took one tablet a day of a NC containing red yeast rice, policosanols, resveratrol and chromium picolinate for 1 month and were compared with an equivalent group of subjects that followed only a diet program. Differences in serum total cholesterol (TC), low-density- and high-density-lipoprotein cholesterol (LDLC and HDLC), triglycerides (TG) and blood glucose between groups were compared by analysis of variance. Results - In both groups, a significant reduction of TC, TG and LDLC was observed. In the treatment group from the baseline to the follow-up the reduction of TC (230.93 ± 28.0 vs. 188.63 ± 18.1, p < 0.001) and LDLC (153.10 ± 22.5 vs. 116.54 ± 17.7, p < 0.001) was significantly greater compared to the control group (differences between treatments = 9.19% and 12.29%, respectively); in addition a significant higher reduction in blood glucose (89.1 ± 7.6 vs. 83.7 ± 4.6, p < 0.001) was also observed (differences between treatments = 4.28%). HDLC levels remained unchanged in both groups. Conclusions - In summary, the NC containing high doses of monacolin K appeared to be safe, well tolerated and effective at improving lipid and glucose patterns.

Medical Subject Headings (MeSH)
AdultBiological ProductsBlood GlucoseCardiovascular DiseasesCholesterol, HDLCholesterol, LDLDietary SupplementsFemaleHumansHypercholesterolemiaHypertensionLipidsLovastatinMaleMiddle AgedRisk FactorsTime FactorsTriglycerides
Study Links
Quality Scores
Safety85
Efficacy90/10
Quality75/10
Citation Metrics
Total Citations12
Citations/Year1.7
Relative Citation Ratio0.69
NIH Percentile36.8%
Research Impact Scores
APT Score0.50
Weight Score1.61
Normalized Score0.85
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