NCT01698294

Biomarkers in Post-Menopausal Women Receiving Flaxseed

A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Female
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• No Evidence of Disease

Interventions

Type	Name	Description
OTHER	Clinical Observation	Participants maintain usual diet and undergo clinical observation
DIETARY_SUPPLEMENT	Flaxseed	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2012-12-14
• Primary completion: 2017-06-08
• Completion: 2017-06-08
• First posted: 2012-10-02
• Last updated: 2022-05-09

Locations

1 site across 1 country: United States