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

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Ground flaxseed

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).

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G2L7
      • Cancer Care Ontario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 57 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in circulating levels of sex steroid hormones at Day 0 (baseline) compared with ~Day 50 (end of study period)	Day 0 and ~Day 50

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in serum enterolignan levels at Day 0 (baseline) compared with ~Day 50 (end of study period)	Day 0 and ~Day 50

Collaborators and Investigators

• Sponsor: Cancer Care Ontario
• Collaborators: University of Toronto; Roswell Park Cancer Institute; Mount Sinai Services; Canadian Breast Cancer Foundation, Ontario Region (funder); York University, Institute for Social Research
• Investigators: Principal Investigator: Michelle Cotterchio, PhD, Cancer Care Ontario and Dalla Lana School of Public Health, University of Toronto

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: July 13, 2015
• First Submitted That Met QC Criteria: July 15, 2015
• First Posted (ESTIMATE): July 17, 2015

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Postmenopause; Hormones; Flaxseed; Lignans; No Evidence of Disease
• Other Study ID Numbers: CBCF 2014-grant

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO