Diet Induced Weight Loss to Reduce Inflammation in Obese Women
Condition: Obesity
MeSH terms: Inflammation; Weight Loss
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      This study aims to determine if weight loss of about 10% of initial weight lowers evidence of
      inflammation in fat stores. It is likely that, if fat store inflammation is reduced, then
      inflammation in breast fat also will be lower. Also, it is possible that blood immune cells
      may be changed with weight loss and even that immune cells in skin will be affected. Since
      vitamin D has important immune effects and vitamin D is low in obesity, we also want to study
      what happens to this vitamin during weight loss.

      This pilot study of weight loss will be done in 10 very obese post menopausal women. This
      study will include nutritional and medical evaluation, a 3 day inpatient hospital stay eating
      a diet providing 50% of what they were taking before starting the study and then a
      nutritionally adequate diet that will allow them to lose about 10% of their initial weight
      within 7 to 10 week period. They will have about 4-5 grams of fat removed by suction through
      a syringe and a biopsy of the skin in addition to studies of blood and stool samples.

      When they have completed the study with a 10% body weight loss they will be referred to a
      nutrition clinic which can counsel them to continue a slower weight loss to an optimal level.
    

Intervention name(s): Diet regimen to induce weight loss
Intervention type(s): Other
Intervention description(s): Diet regimen to induce weight loss
Other intervention name(s): Very low calorie diet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obesity