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Effects of a Western-type Diet on Colorectal Inflammation

Primary Purpose

Colorectal Inflammation

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Western style diet (high fat and low in calcium)

Prudent-style diet (low fat and high in calcium)

About this trial

This is an interventional basic science trial for Colorectal Inflammation

Eligibility Criteria

50 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Healthy male or post-menopausal ( 2 years after menopause or stopping HRT)healthy female subjects
Age between 50 and 72 years
At increased risk for colorectal cancer (this includes those have had a colorectal adenoma excised, or have a first or second degree relative with colorectal neoplasia).

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 or inflammation
Total cholesterol greater than 240mg/dl, triglycerides > 600mg, LDL-C > 175
Subjects with a history of coronary artery disease
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 subject is euthyroid)
Currently participating in other clinical studies or completed participation in other clinical studies within the last 30 days

Sites / Locations

Rockefeller University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Western style diet

Prudent diet

Arm Description

high-fat, low-calcium diet

low-fat, calcium-sufficient diet

Outcomes

Primary Outcome Measures

Inflammation in the rectosigmoid epithelium

Secondary Outcome Measures

Circulating endotoxin levels

Expression profiles of pro- and anti-inflammatory genes in rectosigmoid biopsies

Gut permeability

Inflammatory cytokines in the colorectal mucosa and serum

Luminal and adherent gut microbiota

Fecal calprotectin levels in the stool samples

Full Information

NCT ID

NCT00866450

First Posted

March 19, 2009

Last Updated

January 10, 2012

Sponsor

Rockefeller University

1. Study Identification

Unique Protocol Identification Number

NCT00866450

Brief Title

Effects of a Western-type Diet on Colorectal Inflammation

Official Title

Effects of a Western-type Diet on Colorectal Inflammation, Gut Permeability and Systemic Endotoxemia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (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

This study will look at the inflammatory (changes usually associated with infection/injury to the body) and bowel permeability (bowel's ability to allow contents to enter the body) effects of a Western-style diet (high fat and low in calcium) and a prudent-style diet (low fat and high in calcium) on the colon (large bowel). This study may provide information to prevent colorectal cancer in a high-risk population

Detailed Description

Hypothesis: Compared to a prudent-style diet, does a western-style diet increase colorectal inflammation thereby increasing gut permeability and causing increased endotoxins and markers of systemic inflammation. This is a single blind crossover study. Subjects will be randomized to begin on either a WD or a PD for 30 + 3 days. Once that dietary intervention is complete, subjects will have a four (4) week wash-out period and then will be placed on the other dietary intervention for 30 + 3 days. The following study measures are performed during both the dietary intervention study periods. All the baseline tests will be repeated at the end of each dietary intervention period.

6. Conditions and Keywords

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

Colorectal Inflammation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Western style diet

Arm Type

Active Comparator

Arm Description

high-fat, low-calcium diet

Arm Title

Prudent diet

Arm Type

Active Comparator

Arm Description

low-fat, calcium-sufficient diet

Intervention Type

Dietary Supplement

Intervention Name(s)

Western style diet (high fat and low in calcium)

Intervention Description

Subjects will be randomized to begin on either a WD or a PD for 30 + 3 days. Once that dietary intervention is complete, subjects will have a four (4) week wash-out period and then will be placed on the other dietary intervention for 30 + 3 days

Intervention Type

Dietary Supplement

Intervention Name(s)

Prudent-style diet (low fat and high in calcium)

Intervention Description

Primary Outcome Measure Information:

Title

Inflammation in the rectosigmoid epithelium

Time Frame