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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10065
- The Rockefeller University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Reduced subcutaneous fat (obese)
時間枠:6 weeks
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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.
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6 weeks
|
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Reduced subcutaneous fat (morbidly obese)
時間枠: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.
|
6 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
multiplex bead assay/immunoassay
時間枠: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. |
6 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Peter Holt, MD、The Rockefeller University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- PHO-0702
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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