Colorectal Inflammatory Response to a Western-Style Diet - Full Text View

Sponsored by:	Rockefeller University
Information provided by:	Rockefeller University
ClinicalTrials.gov Identifier:	NCT00932308

Purpose

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.

Condition	Intervention
Colorectal Cancer	Dietary Supplement: Western-style diet (WD) Dietary Supplement: Prudent Diet (PD)

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Active Control, Crossover Assignment, Efficacy Study
Official Title:	Colorectal Inflammatory Response to a Western-Style Diet

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Dietary Supplements Diets

U.S. FDA Resources

Further study details as provided by Rockefeller University:

Primary Outcome Measures:

The degree of inflammation in the rectosigmoid epithelium as judged by the density and composition of the cellular infiltration. [ Time Frame: Day 1 and Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Expression Profiles of pro- and anti-inflammatory genes in rectosigmoid biopsies as determined by microarray assay and RT-PCR. [ Time Frame: Day 1 and Day 28 ] [ Designated as safety issue: No ]
Selected pro- and anti-inflammatory proteins in rectal biopsies [ Time Frame: Day 1 and Day 28 ] [ Designated as safety issue: No ]
The levels of selected circulating and potential urinary inflammatory markers [ Time Frame: Day 27 ] [ Designated as safety issue: No ]
The concentration of fecal calprotectin [ Time Frame: Day -1, 7,14,21 and 27 ] [ Designated as safety issue: No ]
Changes in bulk fecal and epithelial associated microbiota that may determine changes in colorectal epithelial cell biologic pathways. [ Time Frame: Days -1, 7,14,21 and 27 ] [ Designated as safety issue: No ]

Enrollment:	5
Study Start Date:	September 2006
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator 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.

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.

Eligibility

Ages Eligible for Study:	50 Years to 72 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932308

Locations

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

Sponsors and Collaborators

Rockefeller University

Investigators

Principal Investigator:

Peter Holt, MD

Rockefeller University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	The Rockefeller University ( Peter Holt, MD )
Study ID Numbers:	PHO-0588
Study First Received:	December 11, 2008
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00932308 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Calcium, Dietary
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009