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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danone Research ( Danone Japan )
ClinicalTrials.gov Identifier:
NCT01629888
First received: June 26, 2012
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Healthy
Mild Hypercholesterolemia
Other: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).
Other: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink

Resource links provided by NLM:


Further study details as provided by Danone Research:

Enrollment: 48
Study Start Date: February 2010
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629888

Locations
Japan
Senri Chuo Ekimae Clinic
Osaka, Japan, 560-0082
Sponsors and Collaborators
Danone Japan
  More Information

No publications provided

Responsible Party: Danone Research ( Danone Japan )
ClinicalTrials.gov Identifier: NCT01629888     History of Changes
Other Study ID Numbers: NU336
Study First Received: June 26, 2012
Last Updated: June 27, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Institutional Review Board

Keywords provided by Danone Research:
Plant sterol
Hypercholesterolemia
dairy

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014