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Colorectal Inflammatory Response to a Western-Style Diet

50 Years
72 Years
Not Enrolling
Colorectal Cancer

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Trial Information

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.

Inclusion Criteria:

- Healthy male and post-menopausal healthy female subjects, aged 50-72 years, who have
had a colorectal adenoma removed, or have a first or second degree relative with
colorectal neoplasia and thus are themselves at risk for colorectal cancer.

Exclusion Criteria:

- Personal history of cancer other than non-melanoma skin cancer within the past 10

- History of hereditary non-polyposis colon cancer

- Intestinal malabsorption, inflammatory bowel disease

- Prior gastrointestinal surgery other than appendectomy or surgery of the esophagus

- Any excess bleeding or coagulation disorders

- Subjects taking anti-coagulants, sterol-binding resins, NSAIDs other than aspirin, <
600mg per day, other study medications, or other multiple medications that might, in
the view of the study physicians, alter colonic function of inflammation

- Sustained blood pressure > 150/95 mm Hg for three consecutive readings

- Total cholesterol greater than 240mg/dL, triglycerides >600mg, LDL-C > 175

- Subjects with a history of coronary artery disease, with EKG changes consistent with
a past myocardial infarction

- HIV positive subjects

- Subjects taking antibiotics, anti-diabetes, hormone replacement therapy, oral,
transplanted or injected contraceptives (thyroid hormone therapy is permitted as long
as the subjects is euthyroid)

- Subjects consuming a vegetarian diet or a very "prudent diet"

Withdrawal Criteria:

- If a subject is suspected of having taken illicit drugs, the subject will be asked to
take a urine test. If positive, the subject will be withdrawn from the study

- The subject takes any medication prescribed without prior approval of the

- Persistent noncompliance with the diets prescribed by the RUH nutritionists

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Outcome Measure:

The degree of inflammation in the rectosigmoid epithelium as judged by the density and composition of the cellular infiltration.

Outcome Time Frame:

Day 1 and Day 28

Safety Issue:


Principal Investigator

Peter Holt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rockefeller University


United States: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

May 2008

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms



Rockefeller UniversityNew York, New York  10021