NCT00145717

CompletedPhase 3

China Plant Sterol Trial

The George Institute Source

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Other study identifiers

Sponsor study identifier

CPST

Study Type

interventional

Reported enrollment (type unavailable)

300

Locations

1 country

Sites

1

Timeline

Study Start

April 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

July 2005

Date type not reported

This date has not been verified as actual or estimated.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 300 participants
Study completion date: July 2005
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2005
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
July 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 2, 2005
Actual (reported)
First Posted
September 5, 2005
Actual (reported)

Last Updated: September 5, 2005
Status Verified: September 2005
Last Update Submitted: September 2, 2005

Conditions

Cardiovascular Diseases Hypercholesterolemia

Keywords

PhytosterolsCholesterolChinaRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

Low density lipoprotein cholesterol levels

Secondary Outcomes (4)

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

Interventions

Plant sterol enriched milk teaDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age between 18 and 65 years old (inclusive) at baseline
Able to provide informed consent

Sponsors & Collaborators

Peking University
Othercollaborator
The George Institute
Otherlead

Study Sites (1)

Peking University Health Science Centre

Beijing, 100083, China

Related Publications (1)

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.
PMID: 17617940DERIVED

MeSH Terms

Conditions

HypercholesterolemiaCardiovascular Diseases

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

Bruce C Neal, MRCP, PhD
The George Institute
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

April 2005

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

July 2005

Date type not reported

Phase 3

Completed

NCT00143676

Efficacy of Lapaquistat Acetate and Atorvastatin on Blood Cholesterol Levels in Subjects With Primary Hypercholesterolemia

Phase 3Completed

NCT00683618

Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia

Phase 3Completed

NCT00502047

Effect of the Plantago Ovata Husk on the Lipid Profile of Patients With Hypercholesterolemia

Phase 2/3Completed

NCT00263081

Efficacy of Lapaquistat Acetate Co-Administered With Current Lipid-Lowering Treatment on Blood Cholesterol Levels in Subjects With Homozygous Familial Hypercholesterolemia

Phase 3Terminated

NCT00249912

Efficacy of Lapaquistat Acetate Alone or Combined With Rosuvastatin in Subjects With Hypercholesterolemia

Phase 3Completed

NCT00249899

Efficacy of Lapaquistat Acetate Alone or Combined With High-Dose Statin Therapy in Subjects With Hypercholesterolemia

Phase 3Terminated

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

This date has not been verified as actual or estimated.

Last Updated

September 5, 2005

Record last verified: 2005-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00145717
Data provider: ClinicalTrials.gov
Source updated: 2005-09-05
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:37 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations