Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols

Completed · Not applicable

Conditions studied: Hypercholesterolemia

In brief

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 of daily consumption in midly hypercholesterolemic people not treated by statins.

Key facts

Study ID

NCT01340287

Run by

Danone Global Research & Innovation Center

People needed

168

Starts

2008-07-01

Expected to finish

2009-08-01

Last updated by the study team

2016-10-27

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• male/female subject,
• aged from 21 to 75 years,
• BMI between 19 and 30 kg/m2,
• LDL-cholesterol plasma level between 130 and 190 mg/dL without statin monotherapy,
• stabilized hypercholesterolemia,
• accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),
• used to consume dairy products,
• effective contraceptive methods used for female subjects,
• having given written consent to take part in the study

You may not qualify if…

• subject with plasma triglycerides (TG) levels ≥ 350 mg/dL,
• having experienced any cardiovascular event in the last 6 months,
• taking any hypocholesterolemic treatment,
• diabetic subject (type I and type II),
• smoking strictly more than 10 cigarettes / day,
• heavy alcohol intake (> 40 g / day for men ; > 30 g / day for women),
• presenting known allergy or hypersensitivity to milk proteins,
• known soy allergy,
• refusing to stop the consumption of plant sterols-enriched products (other than the studied product),
• receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
• receiving a transplant and under immunosuppressor treatment,
• currently involved in a clinical trial or in an exclusion period following participation in another clinical trial,
• 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,
• 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 or subject likely to change her contraceptive method during the study

Where it is running

• Renstar Medical Research — Ocala, Florida, United States

Full record on ClinicalTrials.gov

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