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Trial registered on ANZCTR


Registration number
ACTRN12606000468527
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
Effect of flaxseed lignans on biomarkers of breast cancer risk in postmenopausal women
Scientific title
Effect of flaxseed lignans on biomarkers of breast cancer risk in postmenopausal women
Secondary ID [1] 315 0
RMIT University Human Research Ethics Committee: Project No. 17/04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 1445 0
Condition category
Condition code
Cancer 1540 1540 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In random order subjects will take orally flaxseed lignan 50mg/ day for 7 weeks, orally flaxseed lignan 100mg/ day for 7 weeks, placebo orally 1/ day 7 weeks with at least a 7 week washout period between each intervention. 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] 1429 0
Prevention
Comparator / control treatment
Placebo orally 1/ day 7 weeks. The placebo tablets contain the same ingredients as the lignan supplements without the Secoisolariciresinol diglucoside.
Control group
Placebo

Outcomes
Primary outcome [1] 2126 0
1. Reduction in total blood estradiol.
Timepoint [1] 2126 0
At 0, 7, 14, 21, 28, 35 weeks.
Primary outcome [2] 2127 0
2. Increase in the 2-hydroxyestrone (2-OHE) to 16-hydroxyestrone (16-OHE) ratio.
Timepoint [2] 2127 0
At 0, 7, 14, 21, 28, 35 weeks.
Secondary outcome [1] 3683 0
1. Increase in urinary enterolactone and enterodiol (flaxseed metabolites).
Timepoint [1] 3683 0
0, 7, 14, 21, 28, 35 weeks
Secondary outcome [2] 3684 0
2. Increase in plasma Sex Hormone Binding Globulin (SHBG) levels.
Timepoint [2] 3684 0
0, 7, 14, 21, 28, 35 weeks.
Secondary outcome [3] 3685 0
3. Dietary analysis.
Timepoint [3] 3685 0
0, 7, 14, 21, 28, 35 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
Gender
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
Crossover
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1680 0
Commercial sector/Industry
Name [1] 1680 0
Melrose Laboratories Pty. Ltd.
Address [1] 1680 0
Country [1] 1680 0
Primary sponsor type
University
Name
RMIT University
Address
Country
Australia
Secondary sponsor category [1] 1482 0
None
Name [1] 1482 0
Nil
Address [1] 1482 0
Country [1] 1482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3126 0
RMIT University Human Research Ethics Committee
Ethics committee address [1] 3126 0
Ethics committee country [1] 3126 0
Australia
Date submitted for ethics approval [1] 3126 0
Approval date [1] 3126 0
10/11/2004
Ethics approval number [1] 3126 0
17/04

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:
1. To directly assess the relationship between dietary consumption of flaxseed lignans and breast cancer risk.
2. To assess the relationship between dietary consumption of flaxseed lignans and concentrations of sex hormone binding globulin and free estradiol.
3. To examine the effects of flaxseed lignans as a dietary constituent on hormonal status in vivo.

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?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27363 0
Address 27363 0
Country 27363 0
Phone 27363 0
Fax 27363 0
Email 27363 0
Contact person for public queries
Name 10618 0
Leah Williamson
Address 10618 0
RMIT University
Food Science Department
GPO Box 2476V
MELBOURNE VIC 3001
Country 10618 0
Australia
Phone 10618 0
0422 505 124, (03) 9925 3967
Fax 10618 0
Email 10618 0
leah.williamson@rmit.edu.au
Contact person for scientific queries
Name 1546 0
Leah Williamson
Address 1546 0
RMIT University
Food Science Department
GPO Box 2476V
MELBOURNE VIC 3001
Country 1546 0
Australia
Phone 1546 0
0422 505 124, (03) 9925 3967
Fax 1546 0
Email 1546 0
leah.williamson@rmit.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary