HypercholesterolemiaPhase 3NCT00145717
China Plant Sterol Trial
A Phase 3 study testing Plant sterol enriched milk tea in people with Hypercholesterolemia and Cardiovascular Diseases, run by The George Institute at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Cardiovascular Diseases
- What is being tested?
- Plant sterol enriched milk tea
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Apr 2005to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hypercholesterolemia, Cardiovascular Diseases
- Being tested
- Plant sterol enriched milk tea
- Keywords
- Phytosterols, Cholesterol, China, Randomized controlled trial
- Medical subject headings
- Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant sterol enriched milk teaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Low density lipoprotein cholesterol levels
Secondary outcomes (4)
Total cholesterol levels;
High density lipoprotein cholesterol levels;
Triglycerides levels;
Liking and adherence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startApr 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Investigators
- Bruce C Neal, MRCP, PhD, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145717
- Sponsor's protocol ID
- CPST
- Status last verified
- Sep 2005
- First submitted
- 2 Sep 2005
- Last updated
- 5 Sep 2005
- Results posted
- No
Publications
Li NY, Li K, Qi Z, Demonty I, Gordon M, Francis L, Molhuizen HO, Neal BC. Plant sterol-enriched milk tea decreases blood cholesterol concentrations in Chinese adults: a randomised controlled trial. Br J Nutr. 2007 Nov;98(5):978-83. doi: 10.1017/S0007114507754302. Epub 2007 Jul 9.
PubMed 17617940
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00145717
- Acronym / sponsor ID
- CPST
- Conditions
- Hypercholesterolemia, Cardiovascular Diseases
- Keywords
- Phytosterols, Cholesterol, China, Randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- Apr 2005
- Study completion
- Jul 2005
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant sterol enriched milk tea | Drug | – |
Primary outcome
Low density lipoprotein cholesterol levels
4 secondary outcomes
Total cholesterol levels;
High density lipoprotein cholesterol levels;
Triglycerides levels;
Liking and adherence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2005.
- Derived from this study: PubMed 17617940Li NY, Li K, Qi Z, Demonty I, Gordon M, Francis L, Molhuizen HO, Neal BC. Plant sterol-enriched milk tea decreases blood cholesterol concentrations in Chinese adults: a randomised controlled trial. Br J Nutr. 2007 Nov;98(5):978-83. doi: 10.1017/S0007114507754302. Epub 2007 Jul 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce C Neal, MRCP, PhD principal investigator
The George Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Plant sterol enriched milk tea in people with Hypercholesterolemia and Cardiovascular Diseases, run by The George Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low density lipoprotein cholesterol levels. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00145717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2005.