None listed
Conditions
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?
Interventions
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 vege
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.
Sponsors
RMIT University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed