A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome
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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Relative percent of Eubacteria composition from qPCR associated with lignan levels
Up to week 21
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|