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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01629888
First Posted: June 28, 2012
Last Update Posted: October 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Danone Research ( Danone Japan )
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink

Further study details as provided by Danone Research ( Danone Japan ):

Enrollment: 48
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629888


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

Responsible Party: Danone Japan
ClinicalTrials.gov Identifier: NCT01629888     History of Changes
Other Study ID Numbers: NU336
First Submitted: June 26, 2012
First Posted: June 28, 2012
Last Update Posted: October 10, 2016
Last Verified: October 2016

Keywords provided by Danone Research ( Danone Japan ):
Plant sterol
Hypercholesterolemia
dairy

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