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

Not Applicable

Completed

• Conditions: Mild Hypercholesterolemic Subjects
• Interventions: Other: 1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).; Other: 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).

• Registration Number: NCT01521156
• Lead Sponsor: Danone Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-11
• Study Completion: 2010-02
• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-30
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Trial Locations

Locations (1)

Harrison Clinical Research Clinical Unit; 🇩🇪 Munich, Germany