China Plant Sterol Trial
|Hypercholesterolemia Cardiovascular Diseases||Drug: Plant sterol enriched milk tea||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||China Plant Sterol Trial – A Randomised Trial to Determine the Effects on Blood Cholesterol Levels of a Milk Tea Product Enriched With Plant Sterol Among 300 Chinese Living in Beijing|
- Low density lipoprotein cholesterol levels
- Total cholesterol levels;
- High density lipoprotein cholesterol levels;
- Triglycerides levels;
- Liking and adherence
|Study Start Date:||April 2005|
|Estimated Study Completion Date:||July 2005|
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 period for participants will be an average of seven weeks comprised of a two-week placebo treatment run-in period prior to randomisation and a five-week follow-up on randomised treatment. An estimated 400 participants will be commenced on run-in with the expectation that 300 (100 in each group) will go on to randomisation.
STUDY TREATMENTS Pre-randomisation open run-in phase: All potentially eligible participants will commence a 10-20 days run-in period with the placebo milk tea administered twice daily. This run-in period will help to identify before randomisation, those individuals who are unlikely to tolerate the milk tea product or comply with the study follow up procedures.
Post randomisation double-blind treatment phase: Participants that successfully complete the run-in phase will be assigned at random to receive either:
- Milk tea containing a total of 2.3g of plant sterol each day administered in two divided doses of 1.15g; or
- Milk tea containing a total of 1.5g of plant sterol each day administered in two divided doses of 0.75g; or
- Placebo milk tea containing no plant sterol. Blinding of participants and investigators will be assured by providing all groups with their allocated treatment in packaging that is identical except for a unique identifying number corresponding to the randomisation code.
- 2.3g/d treatment group compared to placebo group
- 1.5g/d treatment group compared to placebo group
- active treatment group (2.3g/d and 1.5g/d combined) compared to placebo group
- 2.3g/d treatment group compared to 1.5g/d treatment group
- Secondary: To establish the effects of the same intervention on total cholesterol levels.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00145717
|Peking University Health Science Centre|
|Beijing, China, 100083|
|Principal Investigator:||Bruce C Neal, MRCP, PhD||The George Institute|