A Study to Evaluate the Influence of Diet on GI Health

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04783142
Collaborator
(none)
70
2
2
31.7
35
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: High-fiber, low-protein diet
  • Other: Low-fiber, high-protein diet
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are randomly assigned to either the high-fiber, low protein diet or the low-fiber, high-protein diet.Participants are randomly assigned to either the high-fiber, low protein diet or the low-fiber, high-protein diet.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Principal investigator and analysts will be blinded. The participant will not be told to which diet they are randomized.
Primary Purpose:
Basic Science
Official Title:
The Influence of Diet on Host Physiology and Disease Across Diverse Human Gut Microbiotas
Actual Study Start Date :
Jun 11, 2021
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Other: High-fiber, low-protein diet
Diet will consist of at least 15g fiber above baseline and less than 10% of calories from protein.

Other: 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.

Other: Low-fiber, high-protein diet
Diet will consist of less than 15g fiber and greater than 18% of calories from protein

Outcome Measures

Primary Outcome Measures

  1. Urinary Excretion of Lactulose and 13C-Mannitol [4 weeks]

    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.

Secondary Outcome Measures

  1. Change in gut microbial alpha diversity based on Shannon index [4 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905
2 Mayo Clinic Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Purna C. Kashyap, MBBS, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Purna C. Kashyap, MBBS, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04783142
Other Study ID Numbers:
  • 20-008067
First Posted:
Mar 5, 2021
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Purna C. Kashyap, MBBS, Principal Investigator, Mayo Clinic

Study Results

No Results Posted as of Jul 19, 2022