China Plant Sterol Trial

Cardiovascular Diseases Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 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.

Comparisions:

• 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypercholesterolemia

• NCT number: NCT00145717
• Study type: Interventional
• Source: The George Institute
• Status: Completed
• Phase: Phase 3
• Start date: April 2005
• Completion date: July 2005