Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145717
Status:
COMPLETED
Last Update Posted:
2005-09-05
First Post:
2005-09-02
Brief Title:
China Plant Sterol Trial
Sponsor:
The George Institute
Organization:
The George Institute
Study Overview
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
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 23g of plant sterol each day administered in two divided doses of 115g or
Milk tea containing a total of 15g of plant sterol each day administered in two divided doses of 075g 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
23gd treatment group compared to placebo group
15gd treatment group compared to placebo group
active treatment group 23gd and 15gd combined compared to placebo group
23gd treatment group compared to 15gd treatment group
Secondary To establish the effects of the same intervention on total cholesterol levels
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 23g of plant sterol each day administered in two divided doses of 115g or
Milk tea containing a total of 15g of plant sterol each day administered in two divided doses of 075g 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
23gd treatment group compared to placebo group
15gd treatment group compared to placebo group
active treatment group 23gd and 15gd combined compared to placebo group
23gd treatment group compared to 15gd treatment group
Secondary To establish the effects of the same intervention on total cholesterol levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None