Clinical trial NCT02501031: Flaxseed Intervention Study to Assess Sex Hormone Levels Among Post-Menopausal Women
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Flaxseed
Postmenopause
Hormones
Lignans
No Evidence of Disease
Lead sponsor: Cancer Care Ontario
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Foundation, Ontario Region (funder)
name: University of Toronto
name: York University, Institute for Social Research
name: Mount Sinai Services
name: Roswell Park Cancer Institute
First posted: 2015-07-17
Enrollment: 99
Sex: FEMALE
Minimum age (years): 57
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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).

Eligibility 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.

Primary outcomes:
measure: Change in circulating levels of sex steroid hormones at Day 0 (baseline) compared with ~Day 50 (end of study period)
timeFrame: Day 0 and ~Day 50
Secondary outcomes:
measure: Change in serum enterolignan levels at Day 0 (baseline) compared with ~Day 50 (end of study period)
timeFrame: Day 0 and ~Day 50
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Cancer Care Ontario
state: Ontario
Study officials:
affiliation: Cancer Care Ontario and Dalla Lana School of Public Health, University of Toronto
name: Michelle Cotterchio, PhD
role: PRINCIPAL_INVESTIGATOR
References: