A Pilot Study of Docosahexaenoic Acid (DHA) in Obese Menopausal Women

Completed · Not applicable

Conditions studied: Breast Cancer, Obesity

In brief

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.

Key facts

Study ID

NCT01127867

Run by

Rockefeller University

People needed

17

Starts

2010-05-01

Expected to finish

2013-04-01

Last updated by the study team

2017-03-13

Who can join

Age: 40 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Post-menopausal defined as:
• 24 consecutive months without a menstrual period AND
• low serum estradiol level (<40 ng/ml) to be assessed at screening AND
• not taking any medication known to induce ammenorrhea AND
• no known endocrine abnormality associated with irregular/absent menses.
• BMI 35-50.

You may not qualify if…

• Currently taking any hormone therapy: oral, transplanted, vaginal, injected
• Currently taking NSAIDS (if > once a week, stopped < 30 days ago)
• Currently taking oral hypoglycemics
• Currently taking anticoagulant mediation or stopped < 30 days ago
• History of any malignancy or cancer treatment in the past 3 years
• Blood Pressure > 150/90 at screening
• History of any bleeding disorder
• Screening LFT results > 2x normal upper limits
• Screening renal lab results > 2x normal upper limits
• 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.
• History of intestinal malabsorption
• Screening urinalysis positive for blood
• History of chronic diarrhea
• History positive for HIV
• Currently on any medication that can alter fat stores or large bowel inflammation as deemed by the principal investigator
• History of inflammatory bowel disease
• Screening thyroid function test abnormal
• Currently taking any weight control medication
• HIV positive as per POCT rapid test at screening
• Currently taking fish oil, omega-3 supplements or other herbals that exceed the GRAS (Generally Recognized As Safe) levels
• Fasting blood sugar greater than 126 mg/dL at screening
• Currently taking more than 3 antihypertensive medications

Where it is running

• The Rockefeller University — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.