Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000469516
Ethics application status
Approved
Date submitted
2/11/2006
Date registered
9/11/2006
Date last updated
9/11/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Time taken for flaxseed lignans to effect biomarkers of breast cancer risk.
Scientific title
Time taken for flaxseed lignans to effect biomarkers of breast cancer risk.
Secondary ID [1] 316 0
RMIT University Human Research Ethics Committee: Project No. 20/05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 1446 0
Condition category
Condition code
Cancer 1541 1541 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be randomly assigned to a placebo or intervention group. Subjects will take flaxseed lignan orally 100mg/day for a period of 12 weeks.
The lignan supplement contains 48% Secoisolariciresinol diglucoside (lignan precursors), 27% calcium hydrogen phosphate, 19% microcrystalline cellulose, 0.5% hydrogenated vegetable oil, 0.5% stearic acid, 1%magnesium stearate, 2% crospovidone, 2% colloidal silica anhydrous. All tablets are coated in opadry clear PI4029. The only active ingredient in the lignan supplement is Secoisolariciresinol diglucoside.
Intervention code [1] 1430 0
Prevention
Comparator / control treatment
Orally placebo for a period of 12 weeks. The placebo tablets contain the same ingredients as the lignan supplements without the Secoisolariciresinol diglucoside.
Control group
Placebo

Outcomes
Primary outcome [1] 2128 0
1. Reduction in total blood estradiol.
Timepoint [1] 2128 0
At 0, 7, 14, 21, 28, 35 weeks.
Primary outcome [2] 2129 0
2. Increase in the 2-hydroxyestrone (2-OHE) to 16-hydroxyestrone (16-OHE) ratio.
Timepoint [2] 2129 0
At 0, 7, 14, 21, 28, 35 weeks.
Secondary outcome [1] 3686 0
1. Increase in urinary enterolactone and enterodiol (flaxseed metabolites).
Timepoint [1] 3686 0
0, 2, 4, 6, 8, 10, 12 weeks.
Secondary outcome [2] 3687 0
2. Increase in plasma Sex Hormone Binding Globulin (SHBG) levels.
Timepoint [2] 3687 0
0, 2, 4, 6, 8, 10, 12 weeks.
Secondary outcome [3] 3688 0
3. Dietary analysis.
Timepoint [3] 3688 0
0, 2, 4, 6, 8, 10, 12 weeks.

Eligibility
Key inclusion criteria
Subjects must be at least one year post menopausal. Healthy (including no gastrointestinal disorders or food allergies)Have less than 2 alcoholic drinks/day, less than 5/ week.Have less than 3 caffeine beverages/ day.Not been on any antibiotics for the past 6 months.Not been on any hormone replacement therapy for the past 6 months.Do not regularly consume flaxseed or soy products (>3/week).Have consistent medications throughout the study.Within 30% of ideal body weight.Have a diet representative of the total population (>20<45% energy from fat, no exclusion of any food groups).Subjects to maintain body weight and usual exercise habits throughout the study.
Minimum age
40 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects not at least one year post menopausal. Unhealthy (have a gastrointestinal disorder or food allergies)Have more than 2 alcoholic drinks/day, more than 5/ week.Have more than 3 caffeine beverages/ day.Have been on any antibiotics for the past 6 months.Have been on any hormone replacement therapy for the past 6 months.Regularly consume flaxseed or soy products (>3/week).Do not have consistent medications throughout the study.Are not within 30% of ideal body weight.Do not have a diet representative of the total population (>20<45% energy from fat, no exclusion of any food groups).Do not maintain body weight and usual exercise habits throughout the study.

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 involved contacting the holder of the allocation schedule who was off-site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects, therapist, assessor and data analyst are all blinded in the study - double blind.
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 414 0
New Zealand
State/province [1] 414 0

Funding & Sponsors
Funding source category [1] 1681 0
Commercial sector/Industry
Name [1] 1681 0
Melrose Laboratories Pty. Ltd.
Country [1] 1681 0
Primary sponsor type
University
Name
RMIT University
Address
Country
Australia
Secondary sponsor category [1] 1483 0
None
Name [1] 1483 0
Nil
Address [1] 1483 0
Country [1] 1483 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3127 0
RMIT University Human Research Ethics Committee
Ethics committee address [1] 3127 0
Ethics committee country [1] 3127 0
Australia
Date submitted for ethics approval [1] 3127 0
Approval date [1] 3127 0
Ethics approval number [1] 3127 0
20/05

Summary
Brief summary
Data suggests that foods high in lignan precursors are plausibly associated with a lower risk of sex-hormone-related cancers; however the human evidence for this is not strong. Currently, no direct assessment of dietary consumption of lignans and breast cancer risk is available.

The objectives of the proposed research are:

• To directly assess dietary consumption of flaxseed lignans and breast cancer risk.
• To assess urinary lignan concentration and correlate with sex hormone binding globulin concentration and concentration of free estradiol.
• To examine the effects of flaxseed lignans as a dietary constituent on hormonal status in vivo.
• To control flaxseed lignan dietary intake and measure levels enterolactone from matairesinol and enterodiol from secoisolariciresinol in urine to improve understanding for use in epidemiological studies where they may be used as biomarkers of cancer risk.

Research Questions

This research will attempt to answer the following questions:
1. What effects does controlled dietary consumption of lignans have on hormonal status?
2. What effect does controlled lignan dietary consumption have on enterolactone from matairesinol and enterodiol from secoisolariciresinol in urine?
3. What effect does controlled lignan dietary consumption have on hormonal breast cancer risk markers?
4. How long does it take for dietary consumption of lignans to have an effect on hormonal status?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27364 0
Address 27364 0
Country 27364 0
Phone 27364 0
Fax 27364 0
Email 27364 0
Contact person for public queries
Name 10619 0
Leah Williamson
Address 10619 0
RMIT University
Food Science Department
GPO Box 2476V
MELBOURNE VIC 3001
Country 10619 0
Australia
Phone 10619 0
0422 505 124, (03) 9925 3967
Fax 10619 0
Email 10619 0
[email protected]
Contact person for scientific queries
Name 1547 0
Leah Williamson
Address 1547 0
RMIT University
Food Science Department
GPO Box 2476V
MELBOURNE VIC 3001
Country 1547 0
Australia
Phone 1547 0
0422 505 124, (03) 9925 3967
Fax 1547 0
Email 1547 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.