Colorectal Inflammation
Conditions
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.
Interventions
DIETARY_SUPPLEMENTWestern style diet (high fat and low in calcium)
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
DIETARY_SUPPLEMENTPrudent-style diet (low fat and high in calcium)
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
Sponsors
Rockefeller University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 72 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inflammation in the rectosigmoid epithelium | visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Circulating endotoxin levels | 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 |
| Fecal calprotectin levels in the stool samples | 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 |
Countries
United States
Outcome results
None listed