Effect of the Consumption of a Fermented Dairy Product Enriched With Plant Sterols

The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterols after 3 weeks of daily consumption in midly hypercholesterolemic people.

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Key information

Conditions

Mild Hypercholesterolemic Subjects

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harrison Clinical Research Clinical Unit

Munich, 80636, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Male/female subject, aged from 18 to 75,with BMI between 18,5 and 30 kg/m², with LDL-cholesterol blood level between 130 mg/dL to 190 mg/dL without statin therapy.
Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic subject.
Subject used to consume dairy products.
For female subjects: effective contraceptive methods used.
Subject having given written consent to take part in the study.

Exclusion criteria

Subject with blood triglycerides levels above 350 mg/dL.
Subject having experienced any cardiovascular event in the last 6 months.
Subject having sitosterolemia.
Subject taking any hypocholesterolemic treatment drugs.
Intake of blood lipid-regulating supplementation of blood lipid-regulating dietary supplements or functional food during the last 2 weeks before study start.
Diabetic subject (type I and type II).
Subject smoking strictly more than 10 cigarettes / day.
Subject with heavy alcohol intake (> 40 g / day for men ; > 30 g / day for women).
Subject presenting known allergy or hypersensitivity to milk proteins.Subject with known soy allergy.
Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product).
Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.
Subject receiving a transplant and under immunosuppressor treatment.
Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial.
Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.
Subject with any kind of disease likely to interfere with the evaluation of efficiency or safety of the product.
For female subject: pregnancy, breast feeding or intention to be pregnant during the study.
For female subject: subject likely to change her contraceptive method during the study.

Treatment and study plan

1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).

Other

1 = Intervention 1 (1 test product/day)

2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).

Other

2 = Intervention 2 (1 test product/day)

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Official study title

Cholesterol Lowering Effects of a Drinkable Low Fat Dairy Product Enriched With Plant Sterols

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2010
First posted: Jan 30, 2012
Registry last updated: Oct 27, 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.