Trial Information

Summary: Low Calorie Weight Loss Diet Effects on Colonic Inflammation

This study will look for the presence of inflammation (changes usually associated with infection/injury to the body) in the large bowel of people who are overweight, and whether lowering the weight by eating less reduces inflammation in the lining of the large bowel.

Being overweight is linked to a greater risk of developing large bowel (colon) cancer. It is not known how obesity increases the risk of getting large bowel cancer. Animal studies have shown that there is increased inflammation in the large bowel before the development of cancer. This suggests that chronic inflammation might be causing changes that can lead to the development of large bowel cancer.

This study may tell us something about whether increased inflammation exists in the large bowel of overweight people, and whether inflammation is reduced by weight loss.

The expected length of the study is going to be about 13 week period from the time of the screening visit to the final visit.

The time line of the study includes the following:

• Screening and Enrollment visits
• Inpatient admission to Rockefeller University Hospital, which includes:
  • Baseline testing- Baseline testing is done on days 0, 1 and 2 of your inpatient stay. This includes a fasting blood test, sigmoidoscopy with rectal biopsies and stool sample collection.
  • Dietary intervention- approximately 800 calories per day meeting your protein and micronutrient requirements.
  • Final testing after weight loss of 8% of initial body weight- Repeat of baseline tests.

Patient Inclusion Criteria:

• A female between the ages of 21 to 65 years.
• Overweight (BMI greater then 30)*
• No HIV infection.

Patient Exclusion Criteria:

• Currently on any treatment to lose weight

If you would like to learn more about participating in this study, please send an e-mail message using the form below.