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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 = Tested product | Experimental |
| |
| 2 = Control product | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). | Other | 1 = Intervention 1 (3 test products/day) |
|
Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Senri Chuo Ekimae Clinic | Osaka | 560-0082 | Japan |
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| 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters | Other | 2 = Intervention 2 (3 control products/day) |
|
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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