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(PHO-0588) Colorectal Inflammatory Response to a Western-Style Diet


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Colorectal Inflammatory Response to a Western-Style Diet (PHO-0588)

Principal Investigator:
Peter R. Holt M.D.

Investigators:

Contact Information:
Peter Holt, MD
Rockefeller University
1230 York Avenue
New York, NY 10021
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
We are involved in a research program to understand how different diets may affect the risk of colorectal polyps and cancer. To that end, we are conducting a study of a western style diet vs. a “prudent style” diet in which volunteer subjects are provided a different diet for 2 separate 4 week periods at the Rockefeller University Hospital. During one of these 4 week in patient periods they receive a Western style diet and during the other 4 week inpatient period they receive a “Prudent style” diet. We determine changes within the colon as a result of the two different diets. A more detailed description of the study is provided below.



Detailed Description of Protocol:
Study subjects participate for about 3 months. During this time, there is one outpatient visit, a 4 week inpatient period, a 4 week outpatient period known as a wash out period and finally another 4 week inpatient period. During the inpatient periods The Rockefeller University Hospital becomes your home the subject must sleep here every night and consume all the food provided. During the screening visit blood and urine samples will be taken and an EKC (electrocardiogram) and a complete physical exam will be done. After enrollment into the study, the first 4 week inpatient period begins. You may continue to go to work or do other activities as long as you eat the diet provided and sleep at the Rockefeller University Hospital. You must eat everything that we give you and you may not substitute or supplement the diet in any way. During each 4 week stay at The Rockefeller University Hospital, there will be three flexible sigmoidoscopies done and biopsies taken of the mucosal lining of the colorectum. This procedure is painless and takes about 5 minutes. In addition, blood and stool samples will be taken every few days for follow-up and research, two 24 hour urine samples will be done on separate days during the hospitalization. Vital signs are measured every day and your weight will be measured three times per week. During the four week wash out period, the subject will return to their home, go about their normal activities and consume their normal diet. The subject will return to The Rockefeller University Hospital for the second 4 week inpatient period. The procedures and laboratory tests are the same during the second inpatient period. The study concludes with the subjects discharge from the RUH.



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

Healthy Male and post-menopausal healthy female subjects, aged 48-72 years, who have had a colorectal adenoma removed, or have a first or second degree relative with colorectal neoplasia and thus are themselves at increased risk for colorectal cancer.

Gender:
Both

Age(s):
48-72 years

Children permitted to participate:
No

Potential Benefits.....
Better understanding of how Western-diet increases the risk of colon cancer will allow new therapies to be developed to lower the risk. The individual volunteer will gain a better knowledge of her/his health status through comprehensive physical examination and blood tests at no cost to her/him. The Bionutrition Department staff will counsel those desiring dietary change on safe and effective means to do so following completion of the study.



Compensation:
− The subject will be reimbursed at a rate of $250 per week, for the 8 weeks as an inpatient (for a total of $2,000), plus $250 per sigmoidoscopy biopsy for the 4 procedures (for a total of $1,000). − The total compensation amount is $3,000. − The subject will receive $1000.00 at the end of the first In-Patient Period. − The subject will receive the remaining $2000.00 at the end of the second In-Patient Period. If unable to complete the study the subject will be paid a pro-rated amount based on a reimbursement schedule as outlined above.