Effects of Fermented Milk Product Enriched With Plant Sterols and Policosanols in Mild Hypercholesterolaemic Adults

Not Applicable

Completed

• Conditions: Mildly Hypercholesterolemic Subjects
• Interventions: Other: 2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit; Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 10 mg of policosanols per unit; Other: 3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control)

• Registration Number: NCT01571882
• Lead Sponsor: Danone Research

Brief Summary

The objective of this study is to investigate the effect of consumption of a low-fat, no added sugar, dairy fermented product enriched with plant sterols and policosanols at two doses, on LDL-cholesterol concentration in hypercholesterolaemic adults after 3 weeks of product consumption versus active control product.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2007-09
• Study Completion: 2007-10
• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• male and female aged 20-75 years;
• BMI between 19 and 30 kg/m2 ,
• LDL-cholesterol plasma level between 130 mg/dL and 190 mg/dL (bounds included) stabilized for more than 3 months,
• without statin monotherapy or other hypocholesterolaemic drug treatment,
• accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines)

Exclusion Criteria

• serum triglyceride (TG) levels ≥ 4 mmol/L (3.5 g/L), having experienced any cardiovascular event in the last 6 months,
• receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 = tested product 2	2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit	-
1 = Tested product 1	1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 10 mg of policosanols per unit	-
3 = Active control product	3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control)	-

Trial Locations

Locations (1)

Guildford Clinical Pharmacology Unit Ltd. (Gcpl); 🇬🇧 Guildford, Surrey, United Kingdom