European Journal of Nutrition

, Volume 52, Issue 8, pp 1843–1852 | Cite as

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

  • Emmanuel Barrat
  • Yassine Zaïr
  • Pascal Sirvent
  • Patrice Chauveau
  • Corinne Maudet
  • Béatrice Housez
  • Elodie Derbord
  • Jean-François Lescuyer
  • Jean-Marie Bard
  • Murielle Cazaubiel
  • Sébastien L. Peltier
Original Contribution

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.

Keywords

Red yeast rice Policosanols Artichoke leaf extract Muscle breakdown Withdrawal 

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

Notes

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.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  • Emmanuel Barrat
    • 1
  • Yassine Zaïr
    • 2
  • Pascal Sirvent
    • 3
  • Patrice Chauveau
    • 4
  • Corinne Maudet
    • 4
  • Béatrice Housez
    • 4
  • Elodie Derbord
    • 1
  • Jean-François Lescuyer
    • 1
  • Jean-Marie Bard
    • 5
  • Murielle Cazaubiel
    • 4
  • Sébastien L. Peltier
    • 1
  1. 1.Department of ResearchLaboratoire LescuyerAytré CedexFrance
  2. 2.Department of Endocrinology, l’Institut du ThoraxNantes University HospitalNantes Cedex 1France
  3. 3.EA 3533, Laboratoire des Adaptations Métaboliques à l’Exercice en Conditions Physiologiques et PathologiquesClermont Université, Université Blaise PascalClermont-FerrandFrance
  4. 4.Biofortis-Mérieux Nutrisciences CompanySaint-HerblainFrance
  5. 5.LUNAM, EA2160 Nantes et Institut de Cancérologie de l’OuestSaint-HerblainFrance

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