China Plant Sterol Trial

NCT00145717 | Completed Phase 3

• 1 other identifier: CPST
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia; Cardiovascular Diseases

Keywords

Phytosterols; Cholesterol; China; Randomized 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 tea DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• The George Institute: lead
• Peking University: collaborator

Study Sites (1)

Peking University Health Science Centre

Beijing, 100083, China

Location

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: 17617940 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional 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 1, 2005
• Study Completion: July 1, 2005
• Last Updated: September 5, 2005

Record last verified: 2005-09

Locations

CN (1)