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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
| Colorado State University | OTHER |
| University of Minnesota | OTHER |
| Imperial College London |
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Does the small bowel microbiota in healthy individuals change after consumption of a Western diet?
The gut microbiota is increasingly being implicated in disease. However, due to difficulty accessing the small bowel (i.e. requiring upper endoscopy) and the relative paucity of bacteria in this area (secondary to luminal flow and bactericidal bile acids/gastric acid), the small bowel microbiota is infrequently evaluated in any studies of this nature. The small bowel microbiota continues to remain an unexplored area of the gastrointestinal tract. Characterization of the microbial community and its function is the first step in determining how it potentially affects health and disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No western diet | No Intervention | Participants will undergo one-time testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will be finished with testing after the upper endoscopy is complete. | |
| Western diet | Experimental | Participants will undergo a first day of testing for blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies. Participants will then consume a Western diet for 7 days before a second day of identical testing (blood, urine, stool, and upper endoscopy with small bowel aspirates and biopsies). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Western diet | Behavioral | Western diet for 7 days: the meals in this Western diet will be provided by the Clinical Research and Trials Unit (CRTU) after participants meet with the nutrition staff (to discuss food preferences, how to obtain the meals). The meals will reflect a typical Western diet: a low fiber, high sugar diet with weight maintenance calories with < 10 grams fiber per day, and a typical US macronutrient calorie distribution of 50% carbs, 35% fat and 15% protein, with no alcohol. At least 50% of carbohydrates will be provided as simple sugars. |
| Measure | Description | Time Frame |
|---|---|---|
| Transcriptional changes in gut microbiota present in stool. | DNA extraction from stool samples will be done using standard assays. | Baseline, approximately three weeks. |
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Inclusion Criteria:
Adults between (and including) 18-65 years old.
On a baseline healthy diet characterized by:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Purna C Kashyap, M.B.B.S. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Principal investigator will protect the safety of subjects, the validity of data and the integrity of the research by assigning a study identification number to the subject. All information will be kept in a locked file cabinet and all data will be in a password protected computer database. All specimens will be stored in the principal investigator's freezer.
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| ID | Term |
|---|---|
| D066273 | Diet, Western |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| OTHER |
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