Trial reportEuropean journal of nutrition2013
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.
Trial report in European journal of nutrition, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- Pooled it
- A meta-analysis of red yeast rice: an effective and relatively safe alternative approach for dyslipidemia.PloS one · 2014Pooled it
- Effects of a Combined Nutraceutical on Lipid Pattern, Glucose Metabolism and Inflammatory Parameters in Moderately Hypercholesterolemic Subjects: A Double-blind, Cross-over, Randomized Clinical Trial.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2017Trial
- Efficacy, side effects, adherence, affordability, and procurement of dietary supplements for treating hypercholesterolemia: a narrative review.Journal of health, population, and nutrition · 2024Review
- Natural Products as Hepatoprotective Agents-A Comprehensive Review of Clinical Trials.Plants (Basel, Switzerland) · 2024Review
- A scoping review on natural cholesterol lowering supplements sold in South African pharmacies.Health SA = SA Gesondheid · 2024Article
- Evaluation the effects of red yeast rice in combination with statin on lipid profile and inflammatory indices; a randomized clinical trial.BMC nutrition · 2022Article
- Bioactive Compounds from Cardoon as Health Promoters in Metabolic Disorders.Foods (Basel, Switzerland) · 2022Review
- Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels?Current atherosclerosis reports · 2021Review
- Diet and Nutraceutical Supplementation in Dyslipidemic Patients: First Results of an Italian Single Center Real-World Retrospective Analysis.Nutrients · 2020Article
- Lipid lowering nutraceuticals in clinical practice: position paper from an International Lipid Expert Panel.Archives of medical science : AMS · 2017Article
- Effects of long-term supplementation of policosanol on blood cholesterol/glucose levels and 3-hydroxy-3-methylglutaryl coenzyme a reductase activity in a rat model fed high cholesterol diets.Food science and biotechnology · 2016Article
- Effects of a Dietary Supplement with Barley Sprout Extract on Blood Cholesterol Metabolism.Evidence-based complementary and alternative medicine : eCAM · 2015Article
- Red Yeast Rice for Hypercholesterolemia.Methodist DeBakey cardiovascular journalReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo 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.
methodsForty-five healthy subjects (15 per group), with untreated hypercholesterolaemia, were included in this randomised, double-blind, placebo-controlled clinical trial.
resultsAfter 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.
conclusionsSupplementation 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.