Biomarkers in Post-Menopausal Women Receiving Flaxseed

Not Applicable

Completed

• Conditions: No Evidence of Disease
• Interventions: Other: Clinical Observation; Dietary Supplement: Flaxseed; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

• Registration Number: NCT01698294
• Lead Sponsor: Roswell Park Cancer Institute

Brief 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.

Study Timeline

• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-02
• Study Start: 2012-12-14
• Primary Completion: 2017-06-08
• Study Completion: 2017-06-08
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 258

Inclusion Criteria

• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
• Participant must be a non-Hispanic white or non-Hispanic black (self-reported race) woman 45 to 80 years of age and postmenopausal; postmenopausal will be defined as no menstrual cycle in the past 12 months; women with a hysterectomy but with intact ovaries will be included if aged >= 55 years
• Willingness to comply with the requirements of the study

Exclusion Criteria

• Unwilling or unable to follow protocol requirements
• Self-reported race other than non-Hispanic white or non-Hispanic black
• Use, in the 2 months prior to week 1 visit, of antibiotics, hormone replacement therapy, nonprescription hormones or herbal supplements for menopausal symptoms, or flaxseed supplements
• Nut or seed allergy
• Self-reported inflammatory bowel disease
• Gastric bypass
• Use of thyroid replacement medication (Synthroid or similar) for < 1 year
• Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive flaxseed
• Chemotherapy/radiation within the past year
• Body weight greater than 400 pounds (limit of Tanita scale)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group I (flaxseed)	Questionnaire Administration	Participants receive flaxseed PO daily for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group II.
Group II (usual diet)	Laboratory Biomarker Analysis	Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group I.
Group II (usual diet)	Clinical Observation	Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group I.
Group I (flaxseed)	Flaxseed	Participants receive flaxseed PO daily for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group II.
Group I (flaxseed)	Laboratory Biomarker Analysis	Participants receive flaxseed PO daily for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group II.
Group II (usual diet)	Questionnaire Administration	Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group I.

Primary Outcome Measures

Name	Time	Method
Steroid hormone and lignans levels after exposure to a lignan-rich food (flaxseed)	Up to week 21
Relative percent of Eubacteria composition from quantitative polymerase chain reaction (qPCR) associated with lignan levels	Up to week 21

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States