Effect of the Consumption of a Fermented Milk 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 sterol after 3 and 6 weeks of daily consumption in midly hypercholesterolemic people not treated by statins.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renstar Medical Research

Ocala, Florida, United States

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 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

Exclusion criteria

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

Treatment and study plan

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

Dietary Supplement

1 = Intervention 1 (1 test product/day)

2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters

Dietary Supplement

2 = Intervention 2 (1 control product/day)

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Official study title

Effects of the Consumption of a Plant Sterols-enriched Dairy Fermented Product on Hypercholesterolemia Management in Hypercholesterolemic Adults

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Apr 22, 2011
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.

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Completed