Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000098235
Ethics application status
Approved
Date submitted
17/12/2008
Date registered
11/02/2009
Date last updated
11/02/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Do green tea polyphenols decrease hormone and mammographic density in healthy women
Scientific title
A pilot randomised controlled trial to evaluate the effects of Green Tea Polyphenols on Serum Hormone Levels in healthy women
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The prevention of Breast cancer 4138 0
Condition category
Condition code
Cancer 4340 4340 0 0
Breast
Public Health 4507 4507 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Green Tea Polyphenols capsule 700mg oral administration, twice per day with morning and evening meals for 24 weeks
Water soluble, decaffeinated green tea extract containing ‘Tea Polyphenols with (–)-epigallocatechin-3-gallate (EGCG) 65% and over’
Intervention code [1] 4007 0
Prevention
Comparator / control treatment
Placebo tea is coloured microcrystalline cellulose, 700mg oral administration, twice per day with morning and evening meals for 24 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 5222 0
Blood analysis in circulating levels of steroid and peptide hormones
Timepoint [1] 5222 0
pre- and post-intervention
Secondary outcome [1] 8803 0
mammographic density using a high frequency scanner with a computer-aid interactive thresholding technique
Timepoint [1] 8803 0
pre- and post-intervention

Eligibility
Key inclusion criteria
healthy females aged 18+yr, who come to the outpatient breast clinic for medical check
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
they have not given their consent to participate or who had a previous diagnosis of either breast cancer or other malignant diseases

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
using a randomisation table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 1477 0
China
State/province [1] 1477 0
Zhejiang Province

Funding & Sponsors
Funding source category [1] 4308 0
University
Name [1] 4308 0
The University of Western Australia
Country [1] 4308 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Highway, Crawley, Western Australia, 6009
Country
Australia
Secondary sponsor category [1] 3880 0
None
Name [1] 3880 0
Address [1] 3880 0
Country [1] 3880 0
Other collaborator category [1] 519 0
University
Name [1] 519 0
Women's Hospital of Zhejiang University
Address [1] 519 0
1 Xueshi Road, Hangzhou, 310006
Country [1] 519 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6355 0
Human Research Ethics Committee The University of Western Australia
Ethics committee address [1] 6355 0
35 Stirling Highway, Crawley, Western Australia, 6009
Ethics committee country [1] 6355 0
Australia
Date submitted for ethics approval [1] 6355 0
24/11/2008
Approval date [1] 6355 0
Ethics approval number [1] 6355 0
RA/4/1/2238

Summary
Brief summary
a 24-week intervention using encapsulated green tea polyphenols to investigate whether or not green tea polyphenols decrease serum hormone concentration and mammographic density in healthy women
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35046 0
Address 35046 0
Country 35046 0
Phone 35046 0
Fax 35046 0
Email 35046 0
Contact person for public queries
Name 12393 0
Dr Min Zhang
Address 12393 0
School of Population Health
35 Stirling Highway
Crawley, Western Australia, 6009
Country 12393 0
Australia
Phone 12393 0
+(61) (8) 6488 8175
Fax 12393 0
+(61) (8) 6488 1188
Email 12393 0
[email protected]
Contact person for scientific queries
Name 3321 0
Dr Min Zhang
Address 3321 0
School of Population Health
35 Stirling Highway
Crawley, Western Australia, 6009
Country 3321 0
Australia
Phone 3321 0
+(61) (8) 6488 8175
Fax 3321 0
+(61) (8) 6488 1188
Email 3321 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.