Clinical trial · Interventional
A Pilot Study of Docosahexaenoic Acid (DHA) in Obese Menopausal Women
Docosahexaenoic Acid (DHA) Reduces Inflammation and Aromatase Expression in Subcutaneous Fat in Obese Postmenopausal Women: A Pilot Study
NCT01127867CI-TRIAL-00026403completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study aims to determine if a supplement of an omega-3-fatty acid (docosahexaenoic - DHA) lowers inflammation in human fat tissue thereby lowering estrogen production and the potential risk for breast cancer. The investigators also aim to study how this occurs to discover the basis for other potential treatments to lower estrogen production in fat tissue and decrease the 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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dietary intervention | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Reduced subcutaneous fat (obese)
- timeFrame
- 6 weeks
- description
- Reduced subcutaneous fat inflammation changes between pre and post treatment for 5 pilot subject as seen by histologic quantification of monocyte aggregations (crowns), CD68 and CD163 stained macrophages in fat biopsies.
- measure
- Reduced subcutaneous fat (morbidly obese)
- timeFrame
- 6 weeks
- description
- Reduced subcutaneous fat between pre and post treatment for an additional 12 morbidly obese subjects as seen by histologic quantification of monocyte aggregations (crowns), CD68 and CD163 stained macrophages in fat biopsies.
Secondary outcomes (1)
- measure
- multiplex bead assay/immunoassay
- timeFrame
- 6 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: Post-menopausal defined as: 1. 24 consecutive months without a menstrual period AND 2. low serum estradiol level (\<40 ng/ml) to be assessed at screening AND 3. not taking any medication known to induce ammenorrhea AND 4. no known endocrine abnormality associated with irregular/absent menses. 5. BMI 35-50. Exclusion Criteria: 1. Currently taking any hormone therapy: oral, transplanted, vaginal, injected 2. Currently taking NSAIDS (if \> once a week, stopped \< 30 days ago) 3. Currently taking oral hypoglycemics 4. Currently taking anticoagulant mediation or stopped \< 30 days ago 5. History of any malignancy or cancer treatment in the past 3 years 6. Blood Pressure \> 150/90 at screening 7. History of any bleeding disorder 8. Screening LFT results \> 2x normal upper limits 9. Screening renal lab results \> 2x normal upper limits 10. Any condition or situation which, in the investigator's opinion, puts the patient at significant risk, could complicate the study results, or may interfere significantly with participation in the study. 11. History of intestinal malabsorption 12. Screening urinalysis positive for blood 13. History of chronic diarrhea 14. History positive for HIV 15. Currently on any medication that can alter fat stores or large bowel inflammation as deemed by the principal investigator 16. History of inflammatory bowel disease 17. Screening thyroid function test abnormal 18. Currently taking any weight control medication 19. HIV positive as per POCT rapid test at screening 20. Currently taking fish oil, omega-3 supplements or other herbals that exceed the GRAS (Generally Recognized As Safe) levels 21. Fasting blood sugar greater than 126 mg/dL at screening 22. Currently taking more than 3 antihypertensive medications
References
Publications (0)
Data not yet available
No reference posted for this study.