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Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Italy)

NCT ID: NCT01574482

Last Updated: 2016-11-25

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

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-06-30

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 mildly hypercholesterolemic people treated or not by statins

Detailed Description

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Conditions

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Mildly Hypercholesterolemic Subjects

Keywords

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Plant sterol - Hypercholesterolemia - diet - dairy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 = Tested product

Group Type EXPERIMENTAL

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

Intervention Type OTHER

1 = Intervention 1 (1 test product/day)

2 = Control product

Group Type PLACEBO_COMPARATOR

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

Intervention Type OTHER

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 OTHER

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

2 = Intervention 2 (1 control product/day)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* male and female aged 20-75 years; BMI between 19 and 30 kg/m2 , LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without any statin monotherapy, with stabilized hypercholesterolemia (since more than 3 months), accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines), used to consume dairy products, agreeing to a written informed consent, for female: effective contraceptive methods used

Exclusion Criteria

* Subject with plasma triglycerides (TG) levels \> or = 350 mg/dL, with any cardiovascular event in the last 6 months, Subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy, Diabetic (type I and type II), smoking strictly more than 20 cigarettes/day, presenting known allergy or hypersensitivity to milk proteins, and soy, receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, with renal failure or any other metabolic disorder which could interfere with the evaluation of efficiency or safety of the product , pregnant and breast feeding women
Minimum Eligible Age

20 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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Ospedale Silvestrini

Perugia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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NU216

Identifier Type: -

Identifier Source: org_study_id