A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink

October 7, 2016 updated by: Danone Japan
The purpose of this study is to investigate the safety of consumption of three times the standard dose of a yoghurt drink enriched with 1600 mg of plant sterols.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan, 560-0082
        • Senri Chuo Ekimae Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male/female subjects,
  • aged 20-65 years old,
  • triglycerides (TG) levels under 400 mg/dL,
  • total cholesterol plasma level under 240 mg/dL (with half the subjects at entry under 200 mg/dL),
  • LDL-cholesterol plasma level under 160 mg/dL (with half the subjects at entry under 120 mg/dL),
  • non diabetic and non hypertensive,
  • accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (Japan Atherosclerosis Society guidelines),
  • effective contraceptive methods used for female subjects,
  • having given written consent to take part in the study

Exclusion Criteria:

  • subjects with sitosterolemia,
  • subjects with 200 ml of blood taken within the past month or 400 ml or more within the past 3 months,
  • taking any hypocholesterolemic treatment,
  • presenting known allergy or hypersensitivity to plant sterols,
  • dairy products and lactose, subject with heavy alcohol intake (> 60g/day),
  • receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
  • subjects receiving a transplant or under immunosuppressor treatment,
  • receiving treatment for any serious pathology.

  • for female subject:

    • pregnancy,
    • breast feeding or
    • intention to be pregnant during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1 = Tested product
Other: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).
1 = Intervention 1 (3 test products/day)
PLACEBO_COMPARATOR: 2 = Control product
Other: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters
2 = Intervention 2 (3 control products/day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danone Japan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (ESTIMATE)

June 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 10, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU336

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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