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(SWP-0620) Low Calorie Weight Loss Diet Effects on Colonic Inflammation


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Obesity Associated Colonic Inflammation; the Effects of Weight Loss (SWP-0620)

Principal Investigator:
Swaroop Pendyala MD

Investigators:

Contact Information:
Clinical Research Support Office
The Rockefeller University
1230 York Avenue
New York, NY 10021
Telephone: 1800- RUCARES
Email: rucare@rockefeller.edu
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
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.



Detailed Description of Protocol:
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:

1. 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.

2. Dietary intervention- approximately 800 calories per day meeting your protein and micronutrient requirements.

3. Final testing after weight loss of 8% of initial body weight- Repeat of baseline tests. Profile:
A volunteer who is overweight and willing to participate in the very low calorie diet (VLCD) treatment to lose weight, and you are not taking medications known to affect either large bowel inflammation or large bowel function.



What specifically makes a person eligible for the study?
You may be eligible to enter this study:

• A female between the ages of 21 to 65 years.

• Overweight (BMI greater then 30)*

Calculate_BMI

• Currently not on any treatment to lose weight.

• No HIV infection.



Gender:
Female

Age(s):
21-65 years of age

Children permitted to participate:
No

Potential Benefits.....
There is direct benefit to you, by losing weight you will be at a decreased chance of developing various complications like diabetes, hypertension and other risks associated with obesity.



Compensation:
There is no cost to you for being in this research study.

We will provide you a total of $400 for participating in the study. This includes $200 dollars for each of the initial and final testing’s which include blood drawing and rectal biopsy.