Diet Induced Weight Loss to Reduce Inflammation in Obese Women

Completed · Not applicable

Conditions studied: Obesity

In brief

Breast cancer is one of the most frequently seen cancers in the United States. It occurs at all ages but is particularly common in post menopausal women. Obesity increases the risk of breast cancer and colon cancer among others, and when cancer develops increases the risk of spread and death. 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 reduce the risk of breast cancer in obese women as well as the spread of other cancers in the body. Weight reduction in obesity has been shown in epidemiology studies to lower the risk of colon cancer and in obese women to lower the risk of breast cancer. However, how that occurs and how much weight loss is necessary is not known. In mice, calorie restriction in obese animals has been shown to reduce inflammation in fat tissue and the breast. In other studies, calorie reduction has been shown to lower the development of cancer. In addition, we really do not know what starts the whole inflammation process. One good possibility is that immune factors that tend to reduce inflammation are less in obesity. We have shown this in the colon and this also has been suggested as occurring in fat stores.

Key facts

Study ID

NCT01699906

Run by

Rockefeller University

People needed

22

Starts

2012-09-01

Expected to finish

2014-09-01

Last updated by the study team

2014-11-05

Who can join

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

You may qualify if…

• 40-70 years of age
• Post-menopausal women defined as: 24 consecutive months without a menstrual period, currently not taking any medication known to induce amenorhea
• Body Mass Index 35-50

You may not qualify if…

• History of any bleeding disorder
• HIV positive
• History of previous weight loss surgery.
• History of Inflammatory Bowel Disease
• History of any other malignancy other than non-melanoma skin cancer in the past 5 years
• Currently taking fish oil, omega-3 supplements or other herbal supplements that exceed GRAS (Generally Recognized as Safe) levels
• Currently taking any estrogen/progesterone hormones except vaginal cream
• Smokers (or stopped < 3 months ago)
• Currently taking any medication that can alter fat stores as determined by the principal investigator
• Currently taking any weight control medication
• Currently taking hypoglycemic medications.
• Currently taking NSAIDS, aspirin, (if > once a week, stopped <30 days ago). Aspirin 81mg may be permitted if the Framingham Risk Score is < 10
• Currently taking anticoagulant medication or stopped <30 days ago.
• Screening fasting blood glucose >165mg/dL
• Screening thyroid function test abnormal
• Screening LFT results > 2X upper limit of normal
• Screening creatinine > 2X upper limit of normal
• Any condition or situation which, in the opinion of the investigator, puts the patient at significant risk, could complicate the study results, or may interfere significantly with participation in the study.

Where it is running

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

Full record on ClinicalTrials.gov

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