Biomarkers in Post-Menopausal Women Receiving Flaxseed

NCT ID: NCT01698294

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-14
• Study Completion Date: 2017-06-08

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.

Conditions

No Evidence of Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group I (flaxseed)

Participants receive flaxseed PO daily for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group II.

Group Type: EXPERIMENTAL

Flaxseed

Intervention Type: DIETARY_SUPPLEMENT

Given PO

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Group II (usual diet)

Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group I.

Group Type: ACTIVE_COMPARATOR

Clinical Observation

Intervention Type: OTHER

Participants maintain usual diet and undergo clinical observation

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Clinical Observation

Participants maintain usual diet and undergo clinical observation

Intervention Type: OTHER

Flaxseed

Given PO

Intervention Type: DIETARY_SUPPLEMENT

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

FLAX SEED; Flour, Flaxseed; Linseed

Eligibility Criteria

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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Spencer Rosario, PhD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

References

McCann SE, Rodriguez EM, Erwin D, Yao S, Tritchler D, Hullar MAJ, O'Connor T, Lampe JW. Recruitment and Retention of Healthy, Postmenopausal Women of African and European Ancestry: Results from a Dietary Intervention with Repeated Biospecimen Collections. Curr Dev Nutr. 2022 Jan 29;6(3):nzac012. doi: 10.1093/cdn/nzac012. eCollection 2022 Mar.

Reference Type: DERIVED

PMID: 35261959 (View on PubMed)

Other Identifiers

NCI-2012-01246

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 216812

Identifier Type: OTHER

Identifier Source: secondary_id

U01CA161809

Identifier Type: NIH

Identifier Source: secondary_id

View Link

I 216812

Identifier Type: -

Identifier Source: org_study_id