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NCT05619939 · ClinicalTrials.gov registry record · NA
Impact of Protein Source on Gut Health
A NA study of Diet, Healthy, sponsored by Stony Brook University.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05619939: Completed NA study of Diet, Healthy, sponsored by Stony Brook University.
NCT05619939 is a NA study of Diet, Healthy that has completed, run by Stony Brook University. The registered enrollment target is 20 participants, below the 507-participant average among 48 other Diet, Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05619939, a NA study of Diet, Healthy, has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Mass-spectrometry based analysis of the relative abundance of metabolites will be carried out on feces.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Protein isolate
Study Locations (1)
New York
- Stony Brook University - Stony Brook
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-01-18 |
| Est. Completion | 2023-04-28 |
| Phase | NA |
What the finished NCT05619939 record still lists
NCT05619939 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 507-participant average among 48 other Diet, Healthy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Diet, Healthy appearing as the primary indexed condition, and to 1 intervention - of which Protein isolate is the first listed.
NCT05619939 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05619939 about?
NCT05619939 is a clinical study titled "Impact of Protein Source on Gut Health". 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 presenc...
What is the current status of trial NCT05619939?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2023-01-18. Estimated completion is 2023-04-28.
What conditions does trial NCT05619939 study?
This clinical trial studies the following conditions: Diet, Healthy.
What interventions are being tested in trial NCT05619939?
The interventions under investigation include: Protein isolate (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05619939?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05619939 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05619939's enrollment target sits among peer trials
20 43rd of 48 higher than 5 of 48 other Diet, Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diet, Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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