A Study to Evaluate the Influence of Diet on GI Health

NCT04783142 | Completed

• 1 other identifier: 20-008067
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

High-Protein, Low-Fiber Diet

Outcome Measures

Primary Outcomes (1)

• Urinary Excretion of Lactulose and 13C-Mannitol

  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.

  4 weeks

Secondary Outcomes (1)

• Change in gut microbial alpha diversity based on Shannon index

  4 weeks

Study Arms (2)

High-fiber, low-protein diet

OTHER

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

Low-fiber, high-protein diet

OTHER

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

Interventions

High-fiber, low-protein diet OTHER

Diet will consist of at least 15g fiber above baseline and less than 10% of calories from protein.

High-fiber, low-protein diet

Low-fiber, high-protein diet OTHER

Diet will consist of less than 15g fiber and greater than 18% of calories from protein

Low-fiber, high-protein diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Diet, Protein-Restricted; Diet, High-Protein

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Purna C. Kashyap, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Principal investigator and analysts will be blinded. The participant will not be told to which diet they are randomized.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly assigned to either the high-fiber, low protein diet or the low-fiber, high-protein diet.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 5, 2021
• Study Start: June 11, 2021
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)