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Flaxseed Intervention Study to Assess Sex Hormone Levels Among Post-Menopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501031
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : January 12, 2018
Sponsor:
Collaborators:
Canadian Breast Cancer Foundation, Ontario Region (funder)
University of Toronto
York University, Institute for Social Research
Mount Sinai Services
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Cancer Care Ontario

Brief Summary:
The purpose of this study is to understand whether consuming flaxseed for approximately 50 days may beneficially affect the level of certain hormones in the blood thought to be involved in the development of breast cancer. This study will address the first steps toward the development of possible breast cancer prevention strategies. Differences in hormone levels (from blood samples) will be compared between two groups of women - those in the group assigned to eating ground flaxseed daily and those in the control group (with no change in diet).

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Ground flaxseed Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Evaluate whether a dietary flaxseed intervention among post-menopausal women influences circulating levels of sex steroid hormones and estrogen metabolites (including estradiol, estrone, 2-hydroxy(OH)-/16-OH-estrone ratio, SHBG, testosterone, 2-MeOH-E1&-E2, 4-MeOH-E1&-E2) thought to be involved in the development of breast cancer.

SECONDARY OBJECTIVES:

II. Assess a) the effect of flaxseed intake on serum enterolignan levels (lignan biomarker), b) the relationship between serum enterolignan and sex hormone levels.

III. Describe adherence to the flaxseed intervention.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM 1: Participants take 2 tablespoons of ground flaxseed daily for approximately 50 days.

ARM 2: Participants maintain their usual diet for approximately 50 days.

All participants will complete a questionnaire and have their blood drawn at the beginning of the study (Day 0) and at the end of the study period (approximately Day 50).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Dietary Flaxseed on Circulating Sex Hormone Levels Among Post-menopausal Women - an Intervention Trial to Explore Flaxseed Intake as a Possible Breast Cancer Prevention Strategy
Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: Flaxseed (ground) Dietary Supplement: Ground flaxseed
2 tablespoons of ground flaxseed taken daily for approximately 50 days.

No Intervention: Usual diet



Primary Outcome Measures :
  1. Change in circulating levels of sex steroid hormones at Day 0 (baseline) compared with ~Day 50 (end of study period) [ Time Frame: Day 0 and ~Day 50 ]

Secondary Outcome Measures :
  1. Change in serum enterolignan levels at Day 0 (baseline) compared with ~Day 50 (end of study period) [ Time Frame: Day 0 and ~Day 50 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   57 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1. Women residing in Toronto aged 57-64 years old, and post-menopausal.

Exclusion Criteria:

  1. Consumers of flaxseed and soy (including supplements) in the past 6 months.
  2. Consumers of sesame oil and sesame seeds in the past 6 months.
  3. Women who took antibiotics orally in the past 6 months.
  4. Women who took hormone replacement therapy or corticosteroids in the past month.
  5. Non-English speaking.
  6. Current chronic illnesses such as bowel disease (e.g. IBS - irritable bowel syndrome, or IBD - inflammatory bowel disease, such as Crohn's or ulcerative colitis), diabetes, heart disease (e.g. high cholesterol or high blood pressure and on medication for it), cancer, or another chronic illness.
  7. Women who are currently taking blood thinners, such as Warfarin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501031


Locations
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Canada, Ontario
Cancer Care Ontario
Toronto, Ontario, Canada, M5G2L7
Sponsors and Collaborators
Cancer Care Ontario
Canadian Breast Cancer Foundation, Ontario Region (funder)
University of Toronto
York University, Institute for Social Research
Mount Sinai Services
Roswell Park Cancer Institute
Investigators
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Principal Investigator: Michelle Cotterchio, PhD Cancer Care Ontario and Dalla Lana School of Public Health, University of Toronto
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Responsible Party: Cancer Care Ontario
ClinicalTrials.gov Identifier: NCT02501031    
Other Study ID Numbers: CBCF 2014-grant
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cancer Care Ontario:
Flaxseed
Postmenopause
Hormones
Lignans
No Evidence of Disease