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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. (see Contacts and Locations)
Verified February 2017 by Roswell Park Cancer Institute
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
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: February 14, 2017
Last verified: February 2017
  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
No Evidence of Disease
Other: Clinical Observation
Dietary Supplement: Flaxseed
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Basic Science
Official Title: A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Relative percent of Eubacteria composition from quantitative polymerase chain reaction (qPCR) associated with lignan levels [ Time Frame: Up to week 21 ]
  • Steroid hormone and lignans levels after exposure to a lignan-rich food (flaxseed) [ Time Frame: Up to week 21 ]

Estimated Enrollment: 300
Actual Study Start Date: December 14, 2012
Estimated Study Completion Date: June 4, 2019
Estimated Primary Completion Date: July 4, 2018 (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:
  • FLAX SEED
  • Flour, Flaxseed
  • Linseed
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary 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: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary 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 80 Years   (Adult, Senior)
Sexes 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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Roswell Park    877-275-7724    ASKRPCI@RoswellPark.org   
Principal Investigator: Susan McCann         
Sponsors and Collaborators
Roswell Park Cancer Institute
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
State University of New York at Buffalo
University of Toronto
Investigators
Principal Investigator: Susan McCann Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01698294     History of Changes
Other Study ID Numbers: I 216812
NCI-2012-01246 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 216812 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( US NIH Grant/Contract Award Number )
U01CA161809 ( US NIH Grant/Contract Award Number )
Study First Received: September 4, 2012
Last Updated: February 14, 2017

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

ClinicalTrials.gov processed this record on April 27, 2017