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The investigators are involved in a research program to understand how different diets may affect the risk of colorectal polyps and cancer. To that end, the investigators are conducting a study of a western style diet versus a "prudent style" diet in which volunteer subjects are provided a different diet for 2 separate 4 week periods at the Rockefeller University Hospital. During one of these 4 week inpatient periods they receive a Western style diet and during the other 4 week inpatient period they receive a "Prudent style" diet. The investigators will determine changes within the colon as a result of the two different diets. A more detailed description of the study is provided below.
Study subjects participate for about 3 months. During this time, there is one outpatient visit, a 4 week inpatient period, a 4 week outpatient period known as a wash out period and finally another 4 week inpatient period. During the inpatient periods The Rockefeller University Hospital becomes your home the subject must sleep here every night and consume all the food provided. During the screening visit blood and urine samples will be taken and an EKC (electrocardiogram) and a complete physical exam will be done. After enrollment into the study, the first 4 week inpatient period begins. You may continue to go to work or do other activities as long as you eat the diet provided and sleep at the Rockefeller University Hospital. You must eat everything that we give you and you may not substitute or supplement the diet in any way. During each 4 week stay at The Rockefeller University Hospital, there will be three flexible sigmoidoscopies done and biopsies taken of the mucosal lining of the colorectum. This procedure is painless and takes about 5 minutes. In addition, blood and stool samples will be taken every few days for follow-up and research, two 24 hour urine samples will be done on separate days during the hospitalization. Vital signs are measured every day and your weight will be measured three times per week. During the four week wash out period, the subject will return to their home, go about their normal activities and consume their normal diet. The subject will return to The Rockefeller University Hospital for the second 4 week inpatient period. The procedures and laboratory tests are the same during the second inpatient period. The study concludes with the subjects discharge from the RUH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Western-style, high-fat, low-calcium diet (WD) |
|
| 2 | Active Comparator | Prudent, low-fat, calcium sufficient diet (PD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Western-style diet (WD) | Dietary Supplement | Will comprise of approximately 40% fat, 40% carbohydrates, 20% protein, and 350mg calcium, prepared by the Bionutrition Department using the USDA Nutrient Database. |
| Measure | Description | Time Frame |
|---|---|---|
| The degree of inflammation in the rectosigmoid epithelium as judged by the density and composition of the cellular infiltration. | Day 1 and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Expression Profiles of pro- and anti-inflammatory genes in rectosigmoid biopsies as determined by microarray assay and RT-PCR. | Day 1 and Day 28 | |
| Selected pro- and anti-inflammatory proteins in rectal biopsies | Day 1 and Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Holt, 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 |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000072001 | Diet, Healthy |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Prudent Diet (PD) | Dietary Supplement | Will contain approximately 20% fat, 60% carbohydrate, 20% protein, and 1100mg calcium; the diets will consist of a 2-day rotating metabolic menu. |
|
| The levels of selected circulating and potential urinary inflammatory markers | Day 27 |
| The concentration of fecal calprotectin | Day -1, 7,14,21 and 27 |
| Changes in bulk fecal and epithelial associated microbiota that may determine changes in colorectal epithelial cell biologic pathways. | Days -1, 7,14,21 and 27 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |