Normal and Mild Hypercholesterolemic Subjects Clinical Trial
Official title:
Clinical Study for Evaluating the Plasma Cholesterol-reducing Activity of a Plant Sterol-enriched Yoghurt Drink - Effectiveness and Long-term Safety Study
| Verified date | October 2016 |
| Source | Danone Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Institutional Review Board |
| Study type | Interventional |
The purpose of this study is to investigate the effect of consumption of a drinkable low fat fermented milk enriched with 0,8g or 1,6g of plant sterols on reducing plasma cholesterol (LDL-cholesterol) concentration during 12 weeks of product consumption.
| Status | Completed |
| Enrollment | 138 |
| Est. completion date | December 2010 |
| Est. primary completion date | July 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 65 Years |
| Eligibility |
Inclusion Criteria: 1. Subject with total cholesterol plasma level between 200 mg/dL to 240 mg/dL; and LDL-cholesterol between 120 mg/dL to 160 mg/dL. 2. Subject aged from 20 to 65 years (bounds included) 3. Subject with BMI between 19 - 30 kg/m² (bounds included) 4. Subject with triglycerides under 400 mg/dL (4.6 mmol/L) 5. Non diabetic subjects (BS=125 mg/dL) 6. Non hypertensive subjects (SBP<140mmHg and DBP<90 mmHg) 7. Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic 8. Subject agreeing not to consume any other plant sterol supplements or excess plant sterol during the study period 9. Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective; and being able to personally sign a written informed consent and subject having signed the written consent to take part in the study Exclusion Criteria: 1. Subject currently involved in a clinical trial. 2. Subject taking any dislipademia treatment (statins,ezetimibe, niacin, omega-3 FA, fibrates) 3. Subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months of the start of the present study. 4. For female subject: pregnancy or intention to be pregnant during the study. 5. For female subject: breast feeding. 6. Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products. 7. Subject having lactose intolerance. 8. Subjects having sitosterolemia 9. Diabetic subject (Type I and type II) 10. Subject with heavy alcohol intake (>60g/day) 11. Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters 12. Subject receiving a transplant or under immunosuppressor treatment 13. Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders. 14. Subject having cardiovascular history or cardiovascular events (e.g.myocardial infarction, angina pectoris, surgical or endocoronary intervention, stroke, inferior member arteriopathy, etc.) during the last 6 months 15. Subject deemed unsuitable by the investigator. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Japan | Senrichuo Ekimae Clinic - Senri Life Science Center 13F | Osaka |
| Lead Sponsor | Collaborator |
|---|---|
| Danone Japan |
Japan,