China Plant Sterol Trial

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

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 Beijing with whom our Institute has a well-established collaboration. The study will be randomised, placebo-controlled and double-blind. The total study period for participants will be an average of seven weeks comprised of a two-week placebo run-in period and a five-week follow-up on randomised treatment. Randomised treatment will comprise either placebo, low- or standard-dose plant sterol. The primary outcome for the study will be blood cholesterol levels.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The George Institute
• Collaborator: Peking University

Criteria

Inclusion Criteria:

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 Criteria:

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