Biomarkers in Post-Menopausal Women Receiving Flaxseed

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

No Evidence of Disease

Clinical Trial Details

NCT number	NCT01698294
Study type	Interventional
Source	Roswell Park Cancer Institute
Contact
Status	Completed
Phase	N/A
Start date	December 14, 2012
Completion date	June 8, 2017

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