Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04543877 · ClinicalTrials.gov registry record · Early Phase 1
WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study
A Early Phase 1 study, sponsored by USDA, Western Human Nutrition Research Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 60
- Enrollment target
NCT04543877 is a Early Phase 1 study that has completed, run by USDA, Western Human Nutrition Research Center. The registered enrollment target is 60 participants.
The verdict
NCT04543877, a Early Phase 1 study, has completed, sponsored by USDA, Western Human Nutrition Research Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if adding dietary fiber, such as inulin, to a diet that does not have enough fiber would raise the levels of potentially beneficial bacteria, such as Bifidobacterium, in the gut. There is evidence to suggest that these microbes can affect gut health and immune response, including to vaccines. The investigators will examine how inulin in the diet (compared to the maltodextrin control) (1) causes changes in the composition and function of the gut microbes, (2) reduces gut inflammation and gut leakiness caused by the vaccine, (3) increases immune response to vaccination, and (4) changes the expression of important adhesion molecules on the surface of white blood cells. Intestinal and whole-body responses will be measured in all participants.
Interventions
- DIETARY_SUPPLEMENT Maltodextrin
- DIETARY_SUPPLEMENT Inulin
- BIOLOGICAL Ty21a Typhoid Fever Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-09-27 |
| Est. Completion | 2025-06-11 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04543877
The ClinicalTrials.gov registry entry for NCT04543877 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is USDA, Western Human Nutrition Research Center, which has 47 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Maltodextrin is the first listed.
NCT04543877 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04543877 about?
NCT04543877 is a clinical study titled "WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study". The purpose of this study is to determine if adding dietary fiber, such as inulin, to a diet that does not have enough fiber would raise the levels of potentially beneficial bacteria, such as Bifidobacterium, in the gut. There is evidence to suggest that these microbes can affect gut health and immu...
What is the current status of trial NCT04543877?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2022-09-27. Estimated completion is 2025-06-11.
What interventions are being tested in trial NCT04543877?
The interventions under investigation include: Maltodextrin (DIETARY_SUPPLEMENT), Inulin (DIETARY_SUPPLEMENT), Ty21a Typhoid Fever Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04543877?
This trial is sponsored by USDA, Western Human Nutrition Research Center, which has 47 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.