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Trial record 1 of 1 for:    NCT01698294
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Biomarkers in Post-Menopausal Women Receiving Flaxseed

This study is currently recruiting participants.
Verified March 2013 by Roswell Park Cancer Institute
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
State University of New York at Buffalo
University of Toronto
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01698294
First received: September 4, 2012
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention
Healthy, no Evidence of Disease
 Dietary Supplement: flaxseed
Other: clinical observation
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome

Resource links provided by NLM:

MedlinePlus related topics: Cancer Menopause
U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Relative percent of Eubacteria composition from qPCR associated with lignan levels [ Time Frame: Up to week 21 ] [ Designated as safety issue: No ]
  • Steroid hormone and lignans levels after exposure to a lignan-rich food (flaxseed) [ Time Frame: Up to week 21 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: December 2012
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Dietary Supplement: flaxseed
Given PO
Other Names:
  • linseed
  • lint bells
  • linum
  • Linum usitatissimum
Other: laboratory biomarker analysis
Correlative studies
Active Comparator: 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.
 Other: clinical observation
Participants maintain usual diet and undergo clinical observation
Other Name: observation
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 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
  • Able to provide own transportation to and from Roswell Park Cancer Institute (RPCI)

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698294

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: ASK RPCI     877-275-7724     ASKRPCI@RoswellPark.org    
Principal Investigator: Susan McCann            
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
State University of New York at Buffalo
University of Toronto
Investigators
Principal Investigator: Susan McCann Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01698294     History of Changes
Other Study ID Numbers: I 216812, NCI-2012-01246, U01CA161809
Study First Received: September 4, 2012
Last Updated: March 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
gut microbiome; hormones; women; race; phytoestrogens

ClinicalTrials.gov processed this record on May 22, 2013