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Impact of Protein Source on Gut Health

NCT05619939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-19

No results posted yet for this study

Summary

The gastrointestinal (GI) tract is a central hub for human health given its essential role in nutrient absorption, waste production and immunity. Diet is a major contributor to gut health including affecting the incidence and severity of GI disease. This is mediated, at least in part, by the presence of microbiota, a highly diet-dependent biome. In fact, dietary changes are capable of altering bacterial populations and/or microbial metabolism, which in turn, controls the type and abundance of small molecules being produced in the gut, many of which can exert biological effects. Several lines of evidence suggest that dietary protein in particular, can impact gut health. Therefore, this trial will test whether dietary protein type differentially impacts gut function in humans by carrying out a single-blinded randomized cross-over controlled feeding study in healthy individuals. Subjects will be provided with an individualized very low protein diet augmented with pea- or egg white-derived protein supplements, as their major protein source. The impact of consuming pea vs. egg white protein on 1) the fecal metabolome, 2) gut barrier function and 3) gastrointestinal symptoms will be determined.

Conditions

  • Diet, Healthy

Interventions

DIETARY_SUPPLEMENT

Protein isolate

The indicated protein isolates will be given to subjects as their major protein source

Sponsors & Collaborators

Principal Investigators

  • David C Montrose, PhD · Stony Brook University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2023-04-28
Completion
2023-04-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05619939 on ClinicalTrials.gov