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The purpose of this study is to understand the potential of protein and psyllium fiber to manipulate gut microbial densities, intestinal permeability, and inflammation in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-fiber, low-protein diet | Other | Participants will consume a high-fiber, low-protein diet for at least 4 weeks. All meals will be provided free of charge. No substitutions will be permitted. |
|
| Low-fiber, high-protein diet | Other | Participants will consume a low-fiber, high-protein diet for at least 4 weeks. All meals will be provided free of charge. No substitutions will be permitted. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-fiber, low-protein diet | Other | Diet will consist of at least 15g fiber above baseline and less than 10% of calories from protein. |
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| Measure | Description | Time Frame |
|---|---|---|
| Urinary Excretion of Lactulose and 13C-Mannitol | Small Bowel and Colonic Permeability by Urinary Excretion of Lactulose and 13C-Mannitol after Oral Ingestion of lactulose and 13C mannitol (5:1 ratio by mass). The 0-2h urine most closely reflects small intestinal permeability and 8-24h urine reflects colonic permeability. HPLC-tandem mass spectrometry will be used for detection of the sugars. The results will be expressed as the ratio of percentage excretion of the ingested dose of lactulose and mannitol in urine. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gut microbial alpha diversity based on Shannon index | Stool samples will be processed to extract DNA, followed by metagenomic sequencing and assessment of alpha diversity using Shannon index. Comparison will be made using ttest. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Purna C. Kashyap, MBBS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States | ||
| Mayo Clinic |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D018753 | Diet, Protein-Restricted |
| D000073600 | Diet, High-Protein |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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Participants are randomly assigned to either the high-fiber, low protein diet or the low-fiber, high-protein diet.
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Principal investigator and analysts will be blinded. The participant will not be told to which diet they are randomized.
| Low-fiber, high-protein diet | Other | Diet will consist of less than 15g fiber and greater than 18% of calories from protein |
|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |