title: 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: OBJECTIVE
  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.
authors.affiliation: Department of Research, Laboratoire Lescuyer, BP 33, 17442, Aytré Cedex, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Barrat
authors.forename: Yassine
authors.initials: Y
authors.lastname: Zaïr
authors.forename: Pascal
authors.initials: P
authors.lastname: Sirvent
authors.forename: Patrice
authors.initials: P
authors.lastname: Chauveau
authors.forename: Corinne
authors.initials: C
authors.lastname: Maudet
authors.forename: Béatrice
authors.initials: B
authors.lastname: Housez
authors.forename: Elodie
authors.initials: E
authors.lastname: Derbord
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Lescuyer
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Bard
authors.forename: Murielle
authors.initials: M
authors.lastname: Cazaubiel
authors.forename: Sébastien L
authors.initials: SL
authors.lastname: Peltier
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D000924:Anticholesteremic Agents / Q000008:administration & dosage; D001688:Biological Products / Q000008:administration & dosage; D015415:Biomarkers / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood*; D031943:Cynara scolymus / Q000737:chemistry; D019587:Dietary Supplements; D004311:Double-Blind Method; D023381:Endpoint Determination; D005233:Fatty Alcohols / Q000008:administration & dosage; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood* / Q000188:drug therapy; D008019:Life Style; D008297:Male; D008875:Middle Aged; D008928:Mitochondria / Q000187:drug effects / Q000378:metabolism; D018482:Muscle, Skeletal / Q000187:drug effects / Q000378:metabolism; D010936:Plant Extracts / Q000008:administration & dosage*; D018515:Plant Leaves / Q000737:chemistry; D051381:Rats; D017208:Rats, Wistar; D064167:Recommended Dietary Allowances; D014280:Triglycerides / Q000097:blood; D055815:Young Adult
chemical_list: D000924:Anticholesteremic Agents; D001688:Biological Products; D015415:Biomarkers; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D005233:Fatty Alcohols; D010936:Plant Extracts; D014280:Triglycerides; C117343:red yeast rice; C080710:policosanol