Biomarkers in Post-Menopausal Women Receiving Flaxseed

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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No Evidence of Disease

Intervention / Treatment
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* Other: Clinical Observation
* Dietary Supplement: Flaxseed
* Other: Laboratory Biomarker Analysis
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (flaxseed)<br>Participants receive flaxseed PO daily for 6 weeks. After a usual diet washout period of 8 weeks, patients crossover to Group II. | Dietary Supplement: Flaxseed<br>* Given PO<br>* Other names: Linseed;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (usual diet)<br>Participants maintain a usual diet for 6 weeks. After a usual diet washout period of 8 weeks, patients crossover to Group I. | Other: Clinical Observation<br>* Participants maintain usual diet and undergo clinical observation<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut microbiome, hormones, women, race, phytoestrogens