Colorectal Inflammatory Response to a Western-Style Diet
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
The degree of inflammation in the rectosigmoid epithelium as judged by the density and composition of the cellular infiltration.
Day 1 and Day 28
No
Peter Holt, MD
Principal Investigator
Rockefeller University
United States: Institutional Review Board
PHO-0588
NCT00932308
September 2006
May 2008
Name | Location |
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Rockefeller University | New York, New York 10021 |