Trial record 1 of 1 for:    NCT01698294
Previous Study | Return to List | Next Study

Biomarkers in Post-Menopausal Women Receiving Flaxseed

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 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: August 16, 2016
Last verified: August 2016

September 4, 2012
August 16, 2016
December 2012
July 2018   (final data collection date for primary outcome measure)
  • Relative percent of Eubacteria composition from quantitative polymerase chain reaction (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 ]
  • 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 ]
Complete list of historical versions of study NCT01698294 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Biomarkers in Post-Menopausal Women Receiving Flaxseed
A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
No Evidence of Disease
  • Other: Clinical Observation
    Participants maintain usual diet and undergo clinical observation
  • Dietary Supplement: Flaxseed
    Given PO
    Other Names:
    • FLAX SEED
    • Flour, Flaxseed
    • Linseed
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Questionnaire Administration
    Ancillary studies
  • 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.
    Interventions:
    • Dietary Supplement: Flaxseed
    • Other: Laboratory Biomarker Analysis
    • Other: Questionnaire Administration
  • 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.
    Interventions:
    • Other: Clinical Observation
    • Other: Laboratory Biomarker Analysis
    • Other: Questionnaire Administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
Not Provided
July 2018   (final data collection date for primary outcome measure)

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)
Female
45 Years to 80 Years   (Adult, Senior)
Yes
United States
 
NCT01698294
I 216812, NCI-2012-01246, I 216812, P30CA016056, U01CA161809
Yes
Not Provided
Not Provided
Roswell Park Cancer Institute
Roswell Park Cancer Institute
  • Fred Hutchinson Cancer Research Center
  • National Cancer Institute (NCI)
  • State University of New York at Buffalo
  • University of Toronto
Principal Investigator: Susan McCann Roswell Park Cancer Institute
Roswell Park Cancer Institute
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP