Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ground flaxseed | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Flaxseed (ground)
- interventionNames
- Dietary Supplement: Ground flaxseed
- type
- NO_INTERVENTION
- label
- Usual diet
Primary outcomes (1)
- 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 (1)
- measure
- Change in serum enterolignan levels at Day 0 (baseline) compared with ~Day 50 (end of study period)
- timeFrame
- Day 0 and ~Day 50
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 57 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available