MedDataX Logo

Effect of the Consumption of a Fermented Dairy Product Enriched With Plant Sterols

NCT ID: NCT01521156

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterols after 3 weeks of daily consumption in midly hypercholesterolemic people.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Hypercholesterolemic Subjects

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Plant sterols - Hypercholesterolemia - Diet - Dairy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 = Control product

Group Type ACTIVE_COMPARATOR

1- 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 = Tested product

Group Type EXPERIMENTAL

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

Intervention Type OTHER

2 = Intervention 2 (1 test product/day)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

2 = Intervention 2 (1 test product/day)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male/female subject, aged from 18 to 75,with BMI between 18,5 and 30 kg/m², with LDL-cholesterol blood level between 130 mg/dL to 190 mg/dL without statin therapy.
* Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic subject.
* Subject used to consume dairy products.
* For female subjects: effective contraceptive methods used.
* Subject having given written consent to take part in the study.

Exclusion Criteria

* Subject with blood triglycerides levels above 350 mg/dL.
* Subject having experienced any cardiovascular event in the last 6 months.
* Subject having sitosterolemia.
* Subject taking any hypocholesterolemic treatment drugs.
* Intake of blood lipid-regulating supplementation of blood lipid-regulating dietary supplements or functional food during the last 2 weeks before study start.
* Diabetic subject (type I and type II).
* Subject smoking strictly more than 10 cigarettes / day.
* Subject with heavy alcohol intake (\> 40 g / day for men ; \> 30 g / day for women).
* Subject presenting known allergy or hypersensitivity to milk proteins.Subject with known soy allergy.
* Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product).
* Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.
* Subject receiving a transplant and under immunosuppressor treatment.
* Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial.
* Subject 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.
* 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.
* For female subject: subject likely to change her contraceptive method during the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Harrison Clinical Research Clinical Unit

Munich, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NU312

Identifier Type: -

Identifier Source: org_study_id