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

NCT ID: NCT01340287

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypercholesterolemia

Keywords

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Plant sterol Hypercholesterolemia diet dairy isoprostanes Midly hypercholesterolemic subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 = Tested product

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

1 = Intervention 1 (1 test product/day)

2 = Control product

Group Type SHAM_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

2 = Intervention 2 (1 control product/day)

Interventions

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

1 = Intervention 1 (1 test product/day)

Intervention Type DIETARY_SUPPLEMENT

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

2 = Intervention 2 (1 control product/day)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Renstar Medical Research

Ocala, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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NU281

Identifier Type: -

Identifier Source: org_study_id