Scientific Opinion on the substantiation of a health claim related to 3 g/day plant sterols/stanols and lowering blood LDL-cholesterol and reduced risk of (coronary) heart disease pursuant to Article 19 of Regulation (EC) No 1924/2006
TLDR
In this paper, the authors provided a published systematic review and meta-analysis that evaluated the comparative efficacy of plant sterols and plant stanols for lowering blood LDL-cholesterol in healthy and hypercholesterolaemic subjects and an unpublished metaanalysis on 27 randomised controlled human studies on the LDL-lowering efficacy at a dose range between 2.6 and 3.4 g per day.Abstract:
Following an application from Unilever PLC and Unilever NV, submitted pursuant to Article 19 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of an application to modify the conditions of use of an authorised Article 14 claim related to 1.5 – 3.0 g plant sterols/stanols per day and lowering blood LDL-cholesterol by 7 – 12 % and reduced risk of (coronary) heart disease. The applicant has further requested that the minimum duration to obtain the effect be one to two weeks. The applicant provided a published systematic review and meta-analysis that evaluated the comparative efficacy of plant sterols and plant stanols for lowering blood LDL-cholesterol in healthy and hypercholesterolaemic subjects and an unpublished meta-analysis on 27 randomised controlled human studies on the LDL-lowering efficacy at a dose range between 2.6 and 3.4 g per day. On the basis of the data presented, the Panel concludes that plant sterols and stanol esters at daily intakes ranging from 1.5 to 3.0 g plant sterols/stanols in matrices approved by Regulation (EC) No 376/2010 (yellow fat spreads, dairy products, mayonnaise and salad dressings) have a similar efficacy on blood LDL-cholesterol lowering, that plant sterols and stanol esters at a daily intake of 3 g (range 2.6 g to 3.4 g) plant sterols/stanols in matrices approved by Regulation (EC) No 376/2010 lower LDL-cholesterol by 11.3 % (95 % CI: 10.0 – 12.5), and that the minimum duration required to achieve the maximum effect of plant sterols and stanols on LDL-cholesterol lowering is two to three weeks.read more
Citations
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References
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Journal ArticleDOI
Meta-Analysis in Clinical Trials*
TL;DR: This paper examines eight published reviews each reporting results from several related trials in order to evaluate the efficacy of a certain treatment for a specified medical condition and suggests a simple noniterative procedure for characterizing the distribution of treatment effects in a series of studies.
Journal ArticleDOI
Plant sterol-enriched margarines and reduction of plasma total- and LDL-cholesterol concentrations in normocholesterolaemic and mildly hypercholesterolaemic subjects
JA Weststrate,GW Meijer +1 more
TL;DR: A margarine with sterol-esters from soybean oil, mainly esters from sitosterol, campesterol and stigmasterol, is as effective as a margarines enriched with sitostanol-ester in lowering blood total- and LDL-cholesterol levels without affecting HDL-ch cholesterol concentrations.
Journal ArticleDOI
Continuous Dose-Response Relationship of the LDL-Cholesterol–Lowering Effect of Phytosterol Intake
Isabelle Demonty,R. T. Ras,H C M van der Knaap,Guus Duchateau,L. Meijer,Peter L. Zock,Johanna M. Geleijnse,Elke A. Trautwein +7 more
TL;DR: The dose-dependent LDL-C-lowering efficacy ofphytosterols incorporated in various food formats was confirmed and equations of the continuous relationship were established to predict the effect of a given phytosterol dose.
Journal ArticleDOI
Modulation of plasma lipid levels and cholesterol kinetics by phytosterol versus phytostanol esters
Peter B. Jones,Mahmoud Raeini-Sarjaz,Fady Y. Ntanios,Catherine A. Vanstone,Jian Y. Feng,William E. Parsons +5 more
TL;DR: The data indicate that plant sterol and stanol esters differentially lower circulating total and LDL cholesterol levels by suppression of cholesterol absorption in hypercholesterolemic subjects.
Journal ArticleDOI
Effects of 2 low-fat stanol ester–containing margarines on serum cholesterol concentrations as part of a low-fat diet in hypercholesterolemic subjects
TL;DR: It is concluded that the low-fat, plant stanol ester-containing margarines are effective cholesterol-lowering products in hypercholesterolemic subjects when used as part of a low-Fat, low-cholesterol diet.
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