Status:
COMPLETED
Long-term Effectiveness Study on Cholesterol-reducing Activity
Lead Sponsor:
Danone Japan
Conditions:
Normal and Mild Hypercholesterolemic Subjects
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
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)...
Eligibility Criteria
Inclusion
- 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.
- Subject aged from 20 to 65 years (bounds included)
- Subject with BMI between 19 - 30 kg/m² (bounds included)
- Subject with triglycerides under 400 mg/dL (4.6 mmol/L)
- Non diabetic subjects (BS≤125 mg/dL)
- Non hypertensive subjects (SBP\<140mmHg and DBP\<90 mmHg)
- Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic
- Subject agreeing not to consume any other plant sterol supplements or excess plant sterol during the study period
- 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
- Subject currently involved in a clinical trial.
- Subject taking any dislipademia treatment (statins,ezetimibe, niacin, omega-3 FA, fibrates)
- 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.
- For female subject: pregnancy or intention to be pregnant during the study.
- For female subject: breast feeding.
- Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products.
- Subject having lactose intolerance.
- Subjects having sitosterolemia
- Diabetic subject (Type I and type II)
- Subject with heavy alcohol intake (\>60g/day)
- Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
- Subject receiving a transplant or under immunosuppressor treatment
- Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders.
- 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
- Subject deemed unsuitable by the investigator.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT01521169
Start Date
February 1 2010
End Date
December 1 2010
Last Update
October 27 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Senrichuo Ekimae Clinic - Senri Life Science Center 13F
Osaka, Japan, 560-0082