Biomarkers in Post-Menopausal Women Receiving Flaxseed

NCT01698294 | Completed DMC

• 3 other identifiers: I 216812NCI-2012-01246U01CA161809
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

No Evidence of Disease

Keywords

gut microbiome; hormones; women; race; phytoestrogens

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group I (flaxseed)

EXPERIMENTAL

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; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Group II (usual diet)

ACTIVE COMPARATOR

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; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Interventions

Clinical Observation OTHER

Participants maintain usual diet and undergo clinical observation

Group II (usual diet)

Flaxseed DIETARY_SUPPLEMENT

Given PO

Also known as: FLAX SEED, Flour, Flaxseed, Linseed

Group I (flaxseed)

Laboratory Biomarker Analysis OTHER

Correlative studies

Group I (flaxseed); Group II (usual diet)

Questionnaire Administration OTHER

Ancillary studies

Group I (flaxseed); Group II (usual diet)

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Fred Hutchinson Cancer Center: collaborator
• National Cancer Institute (NCI): collaborator
• State University of New York at Buffalo: collaborator
• University of Toronto: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Related Publications (1)

• 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.

  PMID: 35261959 DERIVED

MeSH Terms

Interventions

Watchful Waiting; Linseed Oil

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Spencer Rosario, PhD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: October 2, 2012
• Study Start: December 14, 2012
• Primary Completion: June 8, 2017
• Study Completion: June 8, 2017
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

US (1)