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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: Completed Early Phase 1 study, sponsored by USDA, Western Human Nutrition Research Center.
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, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measurement of baseline level (Day 26; before first vaccine dose) and post-vaccine, antibody response, Immunoglobulin G (IgG), Immunoglobulin M (IgM) and IgA, 7 and 9 days after the first vaccine dose using the antibody-in-lymphocyte-supernatant (ALS) assay to identify antibody-secreting cells in blood. Two antigens will be used: Ty21a outer membrane protein and lipopolysaccharide from Salmonella Typhi.
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 |
What the finished NCT04543877 record still lists
NCT04543877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 3 interventions - of which Maltodextrin is the first listed.
NCT04543877 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04543877's enrollment target sits among peer trials
60 403rd of 2000 higher than 1,565 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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