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
6 participants
INTERVENTIONAL
2021-08-03
2023-02-17
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
SUPPORTIVE_CARE
DOUBLE
Study Groups
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High Protein and Low Fiber Group
Subjects will consume a high protein and low fiber diet for 8 weeks
High Protein and Low Fiber Diet
Protein intake will be increased to be \>40% calories from protein, and the fiber intake will remain \<15gm/day.
Low Protein and High Fiber Group
Subjects will consume a low protein and high fiber diet for 8 weeks
Low Protein and High Fiber Diet
Increase fiber intake up to 40gms of fiber with a requirement to increase at least 15gms above baseline fiber, with 50-75% of total fiber intake from psyllium husk. Subjects will be allowed to slowly increase fiber every two days to reach goal by end of week 1. The total protein will be reduced to \<10% total calories from protein.
Interventions
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High Protein and Low Fiber Diet
Protein intake will be increased to be \>40% calories from protein, and the fiber intake will remain \<15gm/day.
Low Protein and High Fiber Diet
Increase fiber intake up to 40gms of fiber with a requirement to increase at least 15gms above baseline fiber, with 50-75% of total fiber intake from psyllium husk. Subjects will be allowed to slowly increase fiber every two days to reach goal by end of week 1. The total protein will be reduced to \<10% total calories from protein.
Eligibility Criteria
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Inclusion Criteria
2. Ability to give informed consent
3. Diagnosis of ulcerative colitis
4. Moderate UC disease activity defined by a Mayo Score of \>6 with endoscopic score of 2
5. On a baseline diet characterized by:
* Fiber intake of \< 15g/day
* \> 18% of daily calories from protein
Exclusion Criteria
2. Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
3. 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
4. Use of osmotic laxatives and unable or unwilling to stop taking one week prior to permeability test and for the duration of the study
5. Use of oral corticosteroids and unable or unwilling to stop use of oral corticosteroids within the previous 2 weeks and for the duration of the study
6. Multiple dietary restrictions or unable/unwilling to alter dietary protein or dietary fiber.
7. 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
8. Unwilling to stop stenuous exercise (running \>5 miles or equivalent) one week prior to the permeability tests
9. 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
10. Pregnancy or plan to become pregnant during the study time frame
11. Vulnerable adult
12. Known bleeding disorders or takes medications that increase risk of bleeding from mucosal biopsies
13. Use of oral antibiotic(s) within the past 4 weeks (can be enrolled after 4-week washout period)
14. Use of commercial probiotic formulations and unwilling to stop for the duration of the study
15. Diagnosis of diabetes
16. 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
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Laura E. Raffals, M.D
Principal Investigator
Principal Investigators
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Laura Raffals, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
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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20-012389
Identifier Type: -
Identifier Source: org_study_id
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