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Effects of Fermented Milk Product Enriched With Plant Sterols and Policosanols in Mild Hypercholesterolaemic Adults

NCT ID: NCT01571882

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-10-31

Brief Summary

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The objective of this study is to investigate the effect of consumption of a low-fat, no added sugar, dairy fermented product enriched with plant sterols and policosanols at two doses, on LDL-cholesterol concentration in hypercholesterolaemic adults after 3 weeks of product consumption versus active control product.

Detailed Description

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Conditions

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Mildly Hypercholesterolemic Subjects

Keywords

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Plant sterol - Policosanols - Hypercholesterolemia - 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 1

Group Type EXPERIMENTAL

1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 10 mg of policosanols per unit

Intervention Type OTHER

1- Intervention with test product ( 1.6g of plant sterol + 10 mg of policosanols/ day)

2 = tested product 2

Group Type EXPERIMENTAL

2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit

Intervention Type OTHER

2- Intervention with test product (1.6g of plant sterol + 20 mg of policosanols/day)

3 = Active control product

Group Type ACTIVE_COMPARATOR

3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control)

Intervention Type OTHER

3- Intervention with active control product (1,6 g of plant sterol/ day)

Interventions

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1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 10 mg of policosanols per unit

1- Intervention with test product ( 1.6g of plant sterol + 10 mg of policosanols/ day)

Intervention Type OTHER

2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit

2- Intervention with test product (1.6g of plant sterol + 20 mg of policosanols/day)

Intervention Type OTHER

3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control)

3- Intervention with active control product (1,6 g of plant sterol/ 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 and 190 mg/dL (bounds included) stabilized for more than 3 months,
* without statin monotherapy or other hypocholesterolaemic drug treatment,
* accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines)

Exclusion Criteria

* serum triglyceride (TG) levels ≥ 4 mmol/L (3.5 g/L), having experienced any cardiovascular event in the last 6 months,
* receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
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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Guildford Clinical Pharmacology Unit Ltd. (Gcpl)

Guildford, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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NU235

Identifier Type: -

Identifier Source: org_study_id