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Colorectal Inflammatory Response to a Western-Style Diet

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Western-style diet (WD)

Prudent Diet (PD)

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

50 Years - 72 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 If positive, the subject will be withdrawn from the study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

Sites / Locations

Rockefeller University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Expression Profiles of pro- and anti-inflammatory genes in rectosigmoid biopsies as determined by microarray assay and RT-PCR.

Selected pro- and anti-inflammatory proteins in rectal biopsies

The levels of selected circulating and potential urinary inflammatory markers

The concentration of fecal calprotectin

Changes in bulk fecal and epithelial associated microbiota that may determine changes in colorectal epithelial cell biologic pathways.

Full Information

NCT ID

NCT00932308

First Posted

December 11, 2008

Last Updated

February 15, 2012

Sponsor

Rockefeller University

1. Study Identification

Unique Protocol Identification Number

NCT00932308

Brief Title

Colorectal Inflammatory Response to a Western-Style Diet

Official Title

Colorectal Inflammatory Response to a Western-Style Diet

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rockefeller University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Western-style diet (WD)

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Prudent Diet (PD)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

Selected pro- and anti-inflammatory proteins in rectal biopsies

Time Frame

Day 1 and Day 28

Title

The levels of selected circulating and potential urinary inflammatory markers

Time Frame

Day 27

Title

The concentration of fecal calprotectin

Time Frame

Day -1, 7,14,21 and 27

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Holt, MD

Organizational Affiliation

Rockefeller University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rockefeller University

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

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Colorectal Inflammatory Response to a Western-Style Diet

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