Effect of the Consumption of a Fermented Dairy Product En... | NCT01521156

NCT01521156

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 = Control product	Active Comparator		Other: 1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).
2 = Tested product	Experimental		Other: 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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)	1 = Control product

Eligibility Module

Eligibility Criteria

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.