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

NCT01127867 | Completed

• 1 other identifier: PHO-0702
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Obesity

Outcome Measures

Primary Outcomes (2)

• Reduced subcutaneous fat (obese)

  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.

  6 weeks

• Reduced subcutaneous fat (morbidly obese)

  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.

  6 weeks

Secondary Outcomes (1)

• multiplex bead assay/immunoassay

  6 weeks

Interventions

dietary intervention DIETARY_SUPPLEMENT

dietary intervention

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-menopausal defined as:
• 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

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

Related Links

• The Rockefeller University clinical research information page

MeSH Terms

Conditions

Breast Neoplasms; Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Peter Holt, MD

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: May 21, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

US (1)