Status:
COMPLETED
China Plant Sterol Trial
Lead Sponsor:
The George Institute
Collaborating Sponsors:
Peking University
Conditions:
Hypercholesterolemia
Cardiovascular Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The aim of this study is to see if plant sterols are effective at lowering blood cholesterol levels in Chinese people. The study will be done with Chinese colleagues based at Peking University in Beij...
Detailed Description
RESEARCH PLAN The study is a randomised, double-blind, placebo-controlled trial with three parallel groups, two assigned different doses of active treatment and one assigned placebo. The total study p...
Eligibility Criteria
Inclusion
- The key inclusion criteria will be:
- Age between 18 and 65 years old (inclusive) at baseline
- Able to provide informed consent
- Usual diet that includes significant fat consumption at the main meals eaten each week and/or a history of hypercholesterolemia
- Participant is likely to comply with the study treatment during the study period
Exclusion
- Participants will be excluded on the basis of:
- Known serious gastrointestinal disease or other serious illness. Individuals with stable cardiovascular disease will, however, be eligible
- Known lactose intolerance or diet that excludes dairy products
- Known Sitosterolaemia (a very rare genetic condition causing very high blood sitosterol levels)
- Current hospitalisation
- Current use of drug with likely significant impact on gastro-intestinal absorption of cholesterol or plant sterol (e.g. ezetimibe, bile acid-binding resins, or orlistat)
- Participant is currently using or is planning to use non-trial plant sterol/stanol-containing products for the seven week study period
- Participation in another study within last 3 months
- Pregnant or planning to become pregnant in next three months
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00145717
Start Date
April 1 2005
End Date
July 1 2005
Last Update
September 5 2005
Active Locations (1)
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1
Peking University Health Science Centre
Beijing, China, 100083