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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 16, 2014