Skip to Main Content

Clinical Studies and Protocols

Site Map Investigators Log-in
(SWP-0658) Effects of a Western-Type Diet on Colorectal Inflammation

 Return to List of Clinical Studies
 Return to List of Protocols for Obesity, Metabolism and Weight Loss
Effects of a Western-Type Diet on Colorectal Inflammation, Gut Permeability and Systemic Endotoxemia

Principal Investigator:
Swaroop Pendyala MD

Jeanne Walker ANP-C
Diane Meehan MS, RD
Suzanne Magnotta MS, RD
Peter R. Holt M.D.
Jan L. Breslow M.D.

Contact Information:

1230 York Avenue
New York, NY 10065
Telephone: 1-800-RUCARES
Alt. Telephone: 1-800-782-2737
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
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 of Protocol:
This pilot intervention study is designed to determine whether consuming a Western-style, high-fat, low-calcium diet (WD) causes increased inflammation in the colorectal epithelium altering the mucosal permeability leading to increased circulating endotoxin levels compared to a prudent, low-fat, calcium-sufficient diet (PD). This will be a single-blind crossover study under controlled metabolic conditions.

Endpoint measurements will be performed at the beginning and end of each dietary intervention period and include detailed evaluation of blood for circulating endotoxins, cytokine and chemokines levels; urine for gut permeability and urinary prostaglandin metabolites; rectosigmoid biopsies for cellular infiltrates, cytokines, chemokines, adherent microbiota and gene expression analysis by microarray and RT-PCR of selected genes; stool for fecal calprotectin and fecal microbiota.

During a 4-week run-in outpatient period, subjects will be taught by the bionutrition department to maintain their pre-study diets with no high-calcium or high folate-containing foods and stable physical activity as judged by an activity questionnaire and pedometer readings. This will be followed by a crossover experimental inpatient study period of 4 weeks on either WD or PD and 4 weeks on a PD or WD, with a 4-week outpatient washout period in between. Profile:
The study will recruit a total of 5 subjects. We will recruit male and postmenopausal female subjects aged 50-72 years who are at increased risk for colorectal neoplasia. Subjects are screened before enrollment to ensure subjects interest and assess inclusion and exclusion criteria.

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

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



Children permitted to participate:

Potential Benefits.....
There are no direct benefits to study participants.

There is no cost to the subject for participating in the research study. Total compensation for this study is $2,450 to $2,650 based on the total number of inpatient days, sigmoidoscopies and completion of the study.