Colorectal Inflammatory Response to a Western-Style Diet

NCT00932308 | Completed

• 1 other identifier: PHO-0588
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Western-style, high-fat, low-calcium diet (WD)

Dietary Supplement: Western-style diet (WD)

2

ACTIVE COMPARATOR

Prudent, low-fat, calcium sufficient diet (PD)

Dietary Supplement: Prudent Diet (PD)

Interventions

Western-style diet (WD) DIETARY_SUPPLEMENT

Will comprise of approximately 40% fat, 40% carbohydrates, 20% protein, and 350mg calcium, prepared by the Bionutrition Department using the USDA Nutrient Database.

1

Prudent Diet (PD) DIETARY_SUPPLEMENT

Will contain approximately 20% fat, 60% carbohydrate, 20% protein, and 1100mg calcium; the diets will consist of a 2-day rotating metabolic menu.

2

Eligibility Criteria

• Age: 50 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

Rockefeller University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Peter Holt, MD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: July 3, 2009
• Study Start: September 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: February 17, 2012

Record last verified: 2012-02

Locations

US (1)