A Study to Evaluate the Influence of Diet on GI Health

Mayo Clinic

Status: Completed

Conditions: Healthy

Treatments: Other: High-fiber, low-protein diet; Other: Low-fiber, high-protein diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04783142

20-008067

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults ≥ 18 years old
• On a baseline diet characterized by: Fiber intake of </= 20g/day, > 18% of daily calories from protein

Exclusion criteria

• Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

High-fiber, low-protein diet

Other group

Description:

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.

Treatment:

Other: High-fiber, low-protein diet

Low-fiber, high-protein diet

Other group

Description:

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.

Treatment:

Other: Low-fiber, high-protein diet