This randomized clinical trial studies biomarkers in post-menopausal women receiving flaxseed. Studying samples of blood, urine, and feces in the laboratory from participants receiving flaxseed may help doctors understand the effects of flaxseed on biomarkers.
PRIMARY OBJECTIVES: I. To determine associations between the composition of the gut bacterial communities and baseline levels of the mammalian lignans and steroid hormones. II. To determine how variation in gut microbial community composition and in steroid hormone and xenobiotic metabolizing genes affects the metabolism of mammalian lignans and steroid hormones after exposure to a lignan-rich food (flaxseed). III. To determine how these associations differ by race (i.e., African American and European American women). OUTLINE: Participants are randomized to 1 of 2 treatment groups. GROUP I: Participants receive flaxseed orally (PO) daily for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group II. GROUP II: Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group I. After completion of study treatment, participants are followed up for 30 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
258
Participants maintain usual diet and undergo clinical observation
Given PO
Correlative studies
Roswell Park Cancer Institute
Buffalo, New York, United States
Relative percent of Eubacteria composition from quantitative polymerase chain reaction (qPCR) associated with lignan levels
Time frame: Up to week 21
Steroid hormone and lignans levels after exposure to a lignan-rich food (flaxseed)
Time frame: Up to week 21
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Ancillary studies