NCT01629888CompletedNot Applicable
A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink
Danone Japan1 site in 1 country48 target enrollmentStarted: February 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 1
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1 = Tested product
Experimental
Intervention: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). (Other)
2 = Control product
Placebo Comparator
Intervention: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters (Other)
Investigators
Study Sites (1)
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