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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT01127867
First received: May 19, 2010
Last updated: March 9, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Breast Cancer Obesity Dietary Supplement: dietary intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Docosahexaenoic Acid (DHA) Reduces Inflammation and Aromatase Expression in Subcutaneous Fat in Obese Postmenopausal Women: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Reduced subcutaneous fat (obese) [ Time Frame: 6 weeks ]
    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.

  • Reduced subcutaneous fat (morbidly obese) [ Time Frame: 6 weeks ]
    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 Outcome Measures:
  • multiplex bead assay/immunoassay [ Time Frame: 6 weeks ]

    Lowered aromatase expression in fat biopsies accompanied by decreases in the synthetic enzyme COX1-MPGES-1 and/or increase in the catabolic enzyme 15-PGDH and associated changes in BRAC-1 and SIRT-1 expression by immunohistochemical evaluation of CD68, CD168 and CD3 stained monocytes and through examination of the mRNA of imune inflammatory markers in fat biopsies.

    Alteration in serum estradiol and testosterone levels and/or changes in circulating cytokines/chemokines measured by multiplex bead assay and immunoassay.



Enrollment: 17
Study Start Date: May 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: dietary intervention
    dietary intervention
Detailed Description:

Breast cancer is one of the most frequently seen cancers in the United States. Breast cancer occurs at all ages but is particularly common in post menopausal women. Obesity increases the risk of breast cancer primarily of the type that is stimulated by the female sex hormone estrogen. In obesity, fat cells produce estrogen which can alter breast tissue, while lowering blood estrogen reduces the incidence of breast cancer. Inflammation of fat tissue, the coronary blood vessels and the liver are also seen with obesity. Animal experiments have shown the inflammation in fat tissue increases the production of estrogen, thus reducing inflammation in fat tissue might lower estrogen levels and the risk of breast cancer in obese women. A diet high in omega-3-fatty acids, such as those found in fish oil, has been shown in mice to reduce inflammation and aromatase expression (rate limiting enzyme for estrogen synthesis) in fat tissue.

This pilot study of five obese, post-menopausal women and an additional 12 morbidly obese post-menopausal women will include nutritional and medical evaluations, a four day inpatient hospital stay on a regular diet, to measure the inflammation and the estrogen producing machinery of each volunteer subject. Following these baseline measurements, subjects will be provided DHA supplements to take daily for three months and requested to weigh themselves twice weekly at home with the goal of maintaining their weight. Telephone interviews will be performed at scheduled points to check-in with the subjects and after six weeks a return visit to the OPRC will be conducted to assess progress and provide additional supplements. At three months each subject will be readmitted to the hospital and repeat the tests performed before starting on the DHA supplement. If the study shows feasibility and positive results it will be extended to more subjects and other interventions in the future.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127867

Locations
United States, New York
The Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Peter Holt, MD The Rockefeller University
  More Information

Additional Information:
Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT01127867     History of Changes
Other Study ID Numbers: PHO-0702
Study First Received: May 19, 2010
Last Updated: March 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

ClinicalTrials.gov processed this record on August 18, 2017