- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01127867
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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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New York
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New York, New York, Stany Zjednoczone, 10065
- The Rockefeller University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Reduced subcutaneous fat (obese)
Ramy czasowe: 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.
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6 weeks
|
|
Reduced subcutaneous fat (morbidly obese)
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
multiplex bead assay/immunoassay
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Peter Holt, MD, The Rockefeller University
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- PHO-0702
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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