A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink
This study has been completed.
Sponsor:
Danone Japan
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
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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 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 May 19, 2013