Effects of a Western-type Diet on Colorectal Inflammation

NCT00866450 | Completed Early Phase 1

• 1 other identifier: SWP-0658
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Inflammation

Outcome Measures

Primary Outcomes (1)

• Inflammation in the rectosigmoid epithelium

  visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention

Secondary Outcomes (6)

• Circulating endotoxin levels

  visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention

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

  visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention

• Gut permeability

  visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention

• Inflammatory cytokines in the colorectal mucosa and serum

  visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention

• Luminal and adherent gut microbiota

  visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention

Study Arms (2)

Western style diet

ACTIVE COMPARATOR

high-fat, low-calcium diet

Dietary Supplement: Western style diet (high fat and low in calcium)

Prudent diet

ACTIVE COMPARATOR

low-fat, calcium-sufficient diet

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

Interventions

Western style diet (high fat and low in calcium) DIETARY_SUPPLEMENT

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

Western style diet

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

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

Prudent diet

Eligibility Criteria

• Age: 50 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

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 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

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

Rockefeller University

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

Calcium; Diet, Fat-Restricted

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Swaroop Pendyala, MD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: February 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: January 11, 2012

Record last verified: 2012-01

Locations

US (1)