Spots Global Cancer Trial Database for Flaxseed Intervention Study to Assess Sex Hormone Levels Among Post-Menopausal Women

Study Description

Brief Summary: 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).

Detailed Description: 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).

Keywords

Eligibility

Minimum Age: 57 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: Yes

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Contact Details

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