Time taken for flaxseed lignans to effect biomarkers of breast cancer risk.

Completed

• Conditions: Breast cancer; Cancer - Breast

• Registration Number: ACTRN12606000469516
• Lead Sponsor: RMIT University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Reduction in total blood estradiol.[At 0, 7, 14, 21, 28, 35 weeks.];2. Increase in the 2-hydroxyestrone (2-OHE) to 16-hydroxyestrone (16-OHE) ratio.[At 0, 7, 14, 21, 28, 35 weeks.]

Secondary Outcome Measures

Name	Time	Method
1. Increase in urinary enterolactone and enterodiol (flaxseed metabolites). [0, 2, 4, 6, 8, 10, 12 weeks.];2. Increase in plasma Sex Hormone Binding Globulin (SHBG) levels.[0, 2, 4, 6, 8, 10, 12 weeks.];3. Dietary analysis. [0, 2, 4, 6, 8, 10, 12 weeks.]