Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2021-06-11
2023-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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High-fiber, low-protein diet
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.
High-fiber, low-protein diet
Diet will consist of at least 15g fiber above baseline and less than 10% of calories from protein.
Low-fiber, high-protein diet
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.
Low-fiber, high-protein diet
Diet will consist of less than 15g fiber and greater than 18% of calories from protein
Interventions
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High-fiber, low-protein diet
Diet will consist of at least 15g fiber above baseline and less than 10% of calories from protein.
Low-fiber, high-protein diet
Diet will consist of less than 15g fiber and greater than 18% of calories from protein
Eligibility Criteria
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Inclusion Criteria
* On a baseline diet characterized by: Fiber intake of \</= 20g/day, \> 18% of daily calories from protein
Exclusion Criteria
* Known diagnosis of inflammatory bowel disease (Crohn's or ulcerative colitis), microscopic colitis, celiac disease, or other inflammatory GI condition
* Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
* Use of NSAIDs or aspirin and unable or unwilling to stop taking two weeks prior to permeability test and for the duration of the study
* Use of osmotic laxatives and unable or unwilling to stop taking one week prior to permeability test and for the duration of the study
* Use of oral corticosteroids and unable or unwilling to stop use of oral corticosteroids within the previous 6 weeks and for the duration of the study
* Multiple dietary restrictions or unable/unwilling to alter dietary protein or dietary fiber.
* Unwilling to stop ingestion of alcohol and artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages
* Unwilling to stop stenuous exercise (running \>5 miles or equivalent) one week prior to the permeability tests
* Bowel preparation for colonoscopy less than one week prior to completion of the first stool kit and permeability test and flexible sigmoidoscopy and upper endoscopy
* Pregnancy or plan to become pregnant during the study time frame
* Vulnerable adult
* Known bleeding disorders or takes medications that increase risk of bleeding from mucosal biopsies
* Use of oral antibiotic(s) within the past 4 weeks (can be enrolled after 4-week washout period)
* Use of commercial probiotic formulations and unwilling to stop for the duration of the study
* Diagnosis of diabetes
* Any other disease(s), condition(s) or habits(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes
18 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Purna C. Kashyap, MBBS
Principal Investigator
Principal Investigators
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Purna C. Kashyap, MBBS
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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20-008067
Identifier Type: -
Identifier Source: org_study_id
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