Clinical trial NCT04783142: A Study to Evaluate the Influence of Diet on GI Health
Official title: The Influence of Diet on Host Physiology and Disease Across Diverse Human Gut Microbiotas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: High-Protein, Low-Fiber Diet
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to either the high-fiber, low protein diet or the low-fiber, high-protein diet.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Urinary Excretion of Lactulose and 13C-Mannitol
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in gut microbial alpha diversity based on Shannon index
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Purna C. Kashyap, MBBS
role: PRINCIPAL_INVESTIGATOR
References: