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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

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European Journal of Nutrition Aims and scope Submit manuscript

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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Abbreviations

ALE:

Artichoke leaf extract

ALT:

Alanine transaminase

AST:

Aspartate transaminase

CK:

Creatine kinase

DS:

Dietary supplement

HDL-C:

HDL-cholesterol

LDH:

Lactate dehydrogenase

LDL-C:

LDL-cholesterol

PLA:

Placebo

RYR:

Red yeast rice

TAB:

Tablet

TC:

Total cholesterol

ULN:

Upper limit of normality

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Acknowledgments

The Laboratoire Lescuyer, a company commercialising the tested dietary supplement, financed this work. We would like to thank Wanda Lipski for language editing.

Conflict of interest

E.B., E.D., and S.L.P. are employees of the company Laboratoire Lescuyer. J.F.L. is the general director of the company. P.C., C.M., B.H. and M.C. are employed by Biofortis-Mérieux Nutrisciences. The companies Biofortis-Mérieux Nutrisciences and Laboratoire Lescuyer have carried out this trial as a joint venture. Y.Z. and J.M.B. have signed a consultancy agreement with Biofortis-Mérieux Nutrisciences. P.S. declares no conflict of interest.

Author information

Authors and Affiliations

  1. Department of Research, Laboratoire Lescuyer, BP 33, 17442, Aytré Cedex, France

    Emmanuel Barrat, Elodie Derbord, Jean-François Lescuyer & Sébastien L. Peltier

  2. Department of Endocrinology, l’Institut du Thorax, Nantes University Hospital, BP 70721, 44007, Nantes Cedex 1, France

    Yassine Zaïr

  3. EA 3533, Laboratoire des Adaptations Métaboliques à l’Exercice en Conditions Physiologiques et Pathologiques, Clermont Université, Université Blaise Pascal, BP 10448, 63000, Clermont-Ferrand, France

    Pascal Sirvent

  4. Biofortis-Mérieux Nutrisciences Company, 3 route de la Chatterie, 44800, Saint-Herblain, France

    Patrice Chauveau, Corinne Maudet, Béatrice Housez & Murielle Cazaubiel

  5. LUNAM, EA2160 Nantes et Institut de Cancérologie de l’Ouest, 44800, Saint-Herblain, France

    Jean-Marie Bard

Authors
  1. Emmanuel Barrat
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  2. Yassine Zaïr
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  8. Jean-François Lescuyer
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  11. Sébastien L. Peltier
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Corresponding author

Correspondence to Sébastien L. Peltier.

Additional information

This trial has been registered at ClinicalTrials.gov as NCT01354340.

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Barrat, E., Zaïr, Y., Sirvent, P. et al. 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. Eur J Nutr 52, 1843–1852 (2013). https://doi.org/10.1007/s00394-012-0486-2

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  • DOI: https://doi.org/10.1007/s00394-012-0486-2

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