Flaxseed Intervention Study to Assess Sex Hormone Levels Among Post-Menopausal Women
|ClinicalTrials.gov Identifier: NCT02501031|
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : January 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: Ground flaxseed||Not Applicable|
I. Evaluate whether a dietary flaxseed intervention among post-menopausal women influences circulating levels of sex steroid hormones and estrogen metabolites (including estradiol, estrone, 2-hydroxy(OH)-/16-OH-estrone ratio, SHBG, testosterone, 2-MeOH-E1&-E2, 4-MeOH-E1&-E2) thought to be involved in the development of breast cancer.
II. Assess a) the effect of flaxseed intake on serum enterolignan levels (lignan biomarker), b) the relationship between serum enterolignan and sex hormone levels.
III. Describe adherence to the flaxseed intervention.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM 1: Participants take 2 tablespoons of ground flaxseed daily for approximately 50 days.
ARM 2: Participants maintain their usual diet for approximately 50 days.
All participants will complete a questionnaire and have their blood drawn at the beginning of the study (Day 0) and at the end of the study period (approximately Day 50).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Dietary Flaxseed on Circulating Sex Hormone Levels Among Post-menopausal Women - an Intervention Trial to Explore Flaxseed Intake as a Possible Breast Cancer Prevention Strategy|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||January 2018|
|Experimental: Flaxseed (ground)||
Dietary Supplement: Ground flaxseed
2 tablespoons of ground flaxseed taken daily for approximately 50 days.
|No Intervention: Usual diet|
- Change in circulating levels of sex steroid hormones at Day 0 (baseline) compared with ~Day 50 (end of study period) [ Time Frame: Day 0 and ~Day 50 ]
- Change in serum enterolignan levels at Day 0 (baseline) compared with ~Day 50 (end of study period) [ Time Frame: Day 0 and ~Day 50 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501031
|Cancer Care Ontario|
|Toronto, Ontario, Canada, M5G2L7|
|Principal Investigator:||Michelle Cotterchio, PhD||Cancer Care Ontario and Dalla Lana School of Public Health, University of Toronto|