Effect on LDL-cholesterol of a large dose of a dietary supplement with plant extracts in subjects with untreated moderate hypercholesterolaemia: a randomised, double-blind, placebo-controlled study
Abstract
Purpose To determine the effect of 4 weeks of supplementation, then, withdrawal of a dietary supplement (DS) containing red yeast rice extract, policosanol and artichoke leaf extract at twice the recommended daily dose (6 tablets, 6-TAB) compared to the usual dose (3-TAB) or to a placebo (PLA), on blood lipid profiles and safety biomarkers.Methods Forty-five healthy subjects (15 per group), with untreated hypercholesterolaemia, were included in this randomised, double-blind, placebo-controlled clinical trial.Results After 4 weeks of supplementation, LDL-C was significantly lower in 6-TAB (-0.21 g/l; 95 % CI -0.38 to -0.03 g/l; p = 0.0217) and 3-TAB (-0.25 g/l; 95 % CI -0.42 to -0.07 g/l; p = 0.0071) compared to PLA, although no difference in LDL-cholesterol was observed between the two groups, while no effect was seen on triacylglycerol and HDL-cholesterol. Four weeks after the end of supplementation, no difference in LDL-C was seen between the PLA group and the DS-treated groups. The muscle breakdown biomarkers, as well as biomarkers of liver and renal function, were altered by neither dose of the DS. Acute application of the DS on permeabilised skeletal muscle fibres of rats did not induce deleterious effects on mitochondrial function.Conclusions Supplementation with twice the recommended dose of the DS was effective in reducing LDL-cholesterol and appeared safe, but according to the present results, no additional benefit could be achieved compared to the recommended dose.
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The higher dosage of the combination had no safety concerns.
“Doubling the daily dose seemed not to add additional benefits, while there were no safety concerns also with the higher dosage [98].”
From Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels? (2021) · cites this paper as [98]
Doubling the daily dose of the combination did not add additional benefits.
“Doubling the daily dose seemed not to add additional benefits, while there were no safety concerns also with the higher dosage [98].”
From Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels? (2021) · cites this paper as [98]
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- Authors
- Barrat, E., Zaïr, Y., Sirvent, P., Chauveau, P., Maudet, C., Housez, B., Derbord, E., Lescuyer, J.-F., Bard, J.-M., Cazaubiel, M., & Peltier, S. L.
- Affiliations
- Centre Hospitalier Universitaire de Nantes (FR)
- Université Clermont Auvergne (FR)
- Institut de Cancérologie de l'Ouest (FR)
- Venue
- European Journal of Nutrition
- Published
- 2012-12-25
- Volume
- 52
- Issue
- 8
- Pages
- 1843-1852
- ISSN
- 1436-6207 (ISSN-L)
- 1436-6215
- OpenAlex
- W2077513832
- Cited by
- 31
- References
- 35
- Citations by year
- 2024: 4 · 2023: 1 · 2022: 3 · 2021: 3 · 2020: 3 · 2019: 4 · 2018: 1 · 2017: 4 · 2016: 2 · 2015: 2 · 2014: 2 · 2013: 2
- FWCI
- 1.96
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- European Journal of Nutrition (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Natural Products and Biological Research
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Keywords
- LDL cholesterol, hypercholesterolemia, dietary supplements, red yeast rice extract, policosanol, artichoke leaf extract, dose-response relationship, lipid profile, safety biomarkers, mitochondrial function, skeletal muscle fibers, plant extracts
- MeSH terms
- Adolescent, Adult, Aged, Animals, Anticholesteremic Agents, Biological Products, Double-Blind Method, Fatty Alcohols, Female, Humans, Hypercholesterolemia, Life Style, Cholesterol, HDL, Cholesterol, LDL, Male, Middle Aged, Mitochondria, Plant Extracts, Triglycerides, Biomarkers, Rats, Wistar, Muscle, Skeletal, Plant Leaves, Dietary Supplements, Endpoint Determination, Cynara scolymus, Rats, Young Adult, Recommended Dietary Allowances
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