Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Spain)

The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly hypercholesterolemic subjects treated or not by statins.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Sant Joan

Reus, 43201, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

male and female aged 18-75 years;
BMI between 19 and 30 kg/m2 ,
LDL-cholesterol higher than 130 mg/dl in individuals with a 10-year risk ≤ 20% without ischemic cardiopathy; or
higher than 100 mg/dl in individuals with a 10-year risk > 20% or with ischemic cardiopathy (according to NCEP ATPIII guidelines),
with or without statin monotherapy,
willing to respect the dietary advising delivered at the screening visit,
agreeing to a written informed consent

Exclusion criteria

subject with plasma triglycerides (TG) levels > 400 mg/dL,
with any cardiovascular event in the last 6 months,
subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy,
diabetic (type I and type II),
presenting known allergy or hypersensitivity to milk proteins, soy or lactose,
receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
with renal failure or any other metabolic disorder which could interfere with efficacy or safety assessment of the study,
pregnant or breast feeding women

Treatment and study plan

1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit

Other

1 = Intervention 1 (1 test product/day)

2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit

Other

2 = Intervention 2 (1 test product/day)

3- Low fat drinkable fermented dairy product without plant sterols(control)

Other

3 = Intervention 3 (1 control product/day)

Sponsors and collaborators

Lead sponsor

Danone Spain

Industry

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Study on the Effects of a Fermented Dairy Product Enriched With Phytosterols Over Blood Cholesterol Levels of Hypercholesterolemic Adult Subjects

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: May 17, 2012
Registry last updated: Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed