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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501031
• Other study ID #: CBCF 2014-grant
• Status: Completed
• Phase: N/A
• First received: July 13, 2015
• Last updated: January 10, 2018
• Start date: September 2015
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Cancer Care Ontario
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 57 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Ground flaxseed
2 tablespoons of ground flaxseed taken daily for approximately 50 days.

Locations

Country	Name	City	State
Canada	Cancer Care Ontario	Toronto	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
Cancer Care Ontario	Canadian Breast Cancer Foundation, Ontario Region (funder), Mount Sinai Services, Roswell Park Cancer Institute, University of Toronto, York University, Institute for Social Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in serum enterolignan levels at Day 0 (baseline) compared with ~Day 50 (end of study period)		Day 0 and ~Day 50