A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink
NCT ID: NCT01629888
Last Updated: 2016-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2010-02-28
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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1 = Tested product
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)
2 = Control product
2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters
2 = Intervention 2 (3 control products/day)
Interventions
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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)
2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters
2 = Intervention 2 (3 control products/day)
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
65 Years
ALL
Yes
Sponsors
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Danone Japan
INDUSTRY
Responsible Party
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Locations
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Senri Chuo Ekimae Clinic
Osaka, , Japan
Countries
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Other Identifiers
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NU336
Identifier Type: -
Identifier Source: org_study_id
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