Diet Induced Weight Loss to Reduce Inflammation in Obese Women
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.
|Study Design:||Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Diet Induced Weight Loss Reduces Inflammation and Crown-like Structures and Corrects Immune Dysfunction in Subcutaneous Adipose Tissue In Class 2-3 Obese Women: A Pilot Study|
- Adipose tissue inflammation via crown-like structures [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Diet-induced weight loss of 10% body weight will result in reduction in abdominal subcutaneous fat inflammation as measured by:
reduction in adipocyte size determined by microscopy and of CLS number in adipose tissue.
reduction in inflammatory gene expression determined by PCR and selected cytokine protein levels.
increased anti-inflammatory lymphocytes determined by immunohistochemistry or by flowcytometry.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: Dietary intervention
Very low calorie dietary intervention provided to induce a 10% weight loss
Other: Diet regimen to induce weight loss
Diet regimen to induce weight loss
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699906
|United States, New York|
|The Rockefeller University|
|New York, New York, United States, 10065|
|Principal Investigator:||Peter R. Holt, MD||The Rockefeller University|