Clinical trial · Interventional
Effects of Omega-3 Fatty Acids on Risk Factors for Breast Cancer in Pre-menopausal Women
- 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)
Healthy premenopausal women were enrolled in a diet intervention study that examined the effect of a combination EPA/DHA supplement on risk factors associated with breast cancer. In a randomized cross-over design, women consumed their habitual diet with a supplement for three menstrual cycles, had three cycles of wash-out and then consumed a low-fat diet with the same supplement. Blood, urine and nipple aspirate fluid were collected periodically over the 10 month protocol and analyzed for biomarkers associated with supplementation and future risk of breast cancer.
Conditions
Conditions (2)
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 | — |
| Premenopausal Period | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| omega-3 fatty acid | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Habitual supplemented
- description
- habitual diet with 1.2 g EPA+DHA in capsule form/day.
- interventionNames
- Dietary Supplement: omega-3 fatty acid
- type
- EXPERIMENTAL
- label
- Low-fat supplemented
- description
- Reduce dietary fat to less than 20% energy, add 1.2 g EPA+DHA in capsule form/day.
- interventionNames
- Dietary Supplement: omega-3 fatty acid
Primary outcomes (2)
- measure
- omega-3 fatty acid incorporation into red blood cells
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: menstruating, pre-menopausal - Exclusion Criteria: pregnant, lactating, post-menopausal, smoking, on birth control pills \-
References
Publications (1)
- DERIVEDGomes MA, Jia X, Kolenski I, Duncan AM, Meckling KA. The role of background diet on the effects of eicosapentaenoic acid and docosahexaenoic acid supplementation in healthy pre-menopausal women: a randomized, cross-over, controlled study. Lipids Health Dis. 2016 Sep 29;15(1):168. doi: 10.1186/s12944-016-0341-1. PMID 27687127