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

The purpose of this study is to investigate the effect on cholesterolemia profile of a low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in mildly hypercholesterolemic people treated or not by statins.

Completed

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Key information

Conditions

Mildly Hypercholesterolemic Subjects

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

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 plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without statin monotherapy and without any other hypocholesterolemic treatment, accepting to follow the AFSSAPS dietary recommendations for hypercholesterolemic patients, affiliated to a health coverage system, agreeing to a written informed consent

Exclusion criteria

Subject with plasma triglycerides (TG) levels>250 mg/dL, with any cardiovascular event in the last 6 months, taking any hypocholesterolemic treatment) other than statin in monotherapy, Diabetic (type I and type II), receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, with any acute or chronic disease which could impact on results of the study

Treatment and study plan

1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)

Other

1 = Intervention 1 (2 test products / day)

2-Low fat fermented dairy product (control)

Other

2 = Intervention 2 (2 control products/day)

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Official study title

Effect of Low-fat, Fermented Milk Enriched With Plant Sterols on Serum Lipid Profile in Moderate Hypercholesterolemia

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2005
First posted: Apr 10, 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.

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Completed