China Plant Sterol Trial
Condition: Hypercholesterolemia; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): Plant sterol enriched milk tea
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Phytosterols; Cholesterol; China; Randomized controlled trial