Effects of the Consumption of a no Added Sugar Fermented Milk Product Enriched With Plant Sterols and Policosanols on Hypercholesterolaemia Management in Moderately Hypercholesterolaemic Adults

Danone Research1 site in 1 country72 target enrollmentJune 2007

ConditionsMildly Hypercholesterolemic Subjects

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mildly Hypercholesterolemic Subjects
Sponsor: Danone Research
Enrollment: 72
Locations: 1
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

October 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Danone Research

Responsible Party

Sponsor

Eligibility Criteria

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