China Plant Sterol Trial

Sponsor

The George Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00145717

Collaborator

Peking University (Other)

300

Enrollment

Location

Duration (Months)

100.3

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia Cardiovascular Diseases	Drug: Plant sterol enriched milk tea	Phase 3

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 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

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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

Study Start Date :

Apr 1, 2005

Study Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

Low density lipoprotein cholesterol levels []

Secondary Outcome Measures

Total cholesterol levels; []
High density lipoprotein cholesterol levels; []
Triglycerides levels; []
Liking and adherence []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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