Colorectal Inflammatory Response to a Western-Style Diet

The investigators are involved in a research program to understand how different diets may affect the risk of colorectal polyps and cancer. To that end, the investigators are conducting a study of a western style diet versus 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 inpatient periods they receive a Western style diet and during the other 4 week inpatient period they receive a "Prudent style" diet. The investigators will determine changes within the colon as a result of the two different diets. A more detailed description of the study is provided below.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Dietary supplement: Western-style diet (WD); Dietary supplement: Prudent Diet (PD)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Rockefeller University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 years
• 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 investigator
• Persistent noncompliance with the diets prescribed by the RUH nutritionists

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Western-style, high-fat, low-calcium diet (WD)	Dietary supplement: Western-style diet (WD); Will comprise of approximately 40% fat, 40% carbohydrates, 20% protein, and 350mg calcium, prepared by the Bionutrition Department using the USDA Nutrient Database.
Active Comparator: 2; Prudent, low-fat, calcium sufficient diet (PD)	Dietary supplement: Prudent Diet (PD); Will contain approximately 20% fat, 60% carbohydrate, 20% protein, and 1100mg calcium; the diets will consist of a 2-day rotating metabolic menu.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The degree of inflammation in the rectosigmoid epithelium as judged by the density and composition of the cellular infiltration.	Day 1 and Day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Expression Profiles of pro- and anti-inflammatory genes in rectosigmoid biopsies as determined by microarray assay and RT-PCR.	Day 1 and Day 28
Selected pro- and anti-inflammatory proteins in rectal biopsies	Day 1 and Day 28
The levels of selected circulating and potential urinary inflammatory markers	Day 27
The concentration of fecal calprotectin	Day -1, 7,14,21 and 27
Changes in bulk fecal and epithelial associated microbiota that may determine changes in colorectal epithelial cell biologic pathways.	Days -1, 7,14,21 and 27

Collaborators and Investigators

• Sponsor: Rockefeller University
• Investigators: Principal Investigator: Peter Holt, MD, Rockefeller University

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: December 11, 2008
• First Submitted That Met QC Criteria: July 1, 2009
• First Posted (Estimate): July 3, 2009

Study Record Updates

• Last Update Posted (Estimate): February 17, 2012
• Last Update Submitted That Met QC Criteria: February 15, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: PHO-0588