Healthy Clinical Trial
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
The purpose of this study is to understand whether consuming flaxseed for approximately 50 days may beneficially affect the level of certain hormones in the blood thought to be involved in the development of breast cancer. This study will address the first steps toward the development of possible breast cancer prevention strategies. Differences in hormone levels (from blood samples) will be compared between two groups of women - those in the group assigned to eating ground flaxseed daily and those in the control group (with no change in diet).
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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).
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