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

NCT02501031 | Completed

• 1 other identifier: CBCF 2014-grant
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

Flaxseed; Postmenopause; Hormones; Lignans; No Evidence of Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in serum enterolignan levels at Day 0 (baseline) compared with ~Day 50 (end of study period)

  Day 0 and ~Day 50

Study Arms (2)

Flaxseed (ground)

EXPERIMENTAL

Dietary Supplement: Ground flaxseed

Usual diet

NO INTERVENTION

Interventions

Ground flaxseed DIETARY_SUPPLEMENT

2 tablespoons of ground flaxseed taken daily for approximately 50 days.

Flaxseed (ground)

Eligibility Criteria

• Age: 57 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Consumers of flaxseed and soy (including supplements) in the past 6 months.
• Consumers of sesame oil and sesame seeds in the past 6 months.
• Women who took antibiotics orally in the past 6 months.
• Women who took hormone replacement therapy or corticosteroids in the past month.
• Non-English speaking.
• 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.
• Women who are currently taking blood thinners, such as Warfarin.

Sponsors & Collaborators

• Cancer Care Ontario: lead
• Canadian Breast Cancer Foundation, Ontario Region (funder): collaborator
• University of Toronto: collaborator
• York University, Institute for Social Research: collaborator
• Mount Sinai Services: collaborator
• Roswell Park Cancer Institute: collaborator

Study Sites (1)

Cancer Care Ontario

Toronto, Ontario, M5G2L7, Canada

Location

Study Officials

• Michelle Cotterchio, PhD

  Cancer Care Ontario and Dalla Lana School of Public Health, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 17, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: January 1, 2018
• Last Updated: January 12, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)