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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Western style diet | Active Comparator | high-fat, low-calcium diet |
|
| Prudent diet | Active Comparator | low-fat, calcium-sufficient diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation in the rectosigmoid epithelium | visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Swaroop Pendyala, MD | Rockefeller University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rockefeller University | New York | New York | 10065 | United States |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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|
| 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 |
|
| 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 |
| Fecal calprotectin levels in the stool samples | visit 1, 30 days after the first dietary intervention and 30 days after the second dietary intervention |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |