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NCT04159259 · ClinicalTrials.gov registry record · NA
Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome (FIB)
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT04159259 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 13 participants.
The verdict
NCT04159259, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study Summary
All subjects will complete a 49-day, multi-phase feeding study to evaluate the effect of pea fiber supplementation on gut community structure and features of host biological state (plasma proteome/ metabolome). Subjects will be asked to continue to consume their habitual diet (free diet phase) for 4 days prior to being provided with a diet high in saturated fat (HiSF) and low in fruits and vegetables (LoFV) in the form of packed-out meals and snacks to consume for the following 45 days. Ten days after starting to consume the HiSF-LoFV diet, subjects will supplement their diet with pea fiber for a total of 21 days; the energy contribution from the HiSF-LoFV diet will be reduced accordingly to maintain energy needs during this time. After completing the pea fiber supplementation phase of the study subjects will revert back to consuming the HiSF-LoFV only diet for the final 14 days. Stool, urine and blood will be sampled periodically throughout.
Interventions
- OTHER Low fiber diet
- OTHER Pea Fiber Bar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-02-13 |
| Est. Completion | 2020-06-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04159259
The ClinicalTrials.gov registry entry for NCT04159259 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Low fiber diet is the first listed.
NCT04159259 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04159259 about?
NCT04159259 is a clinical study titled "Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome (FIB)". All subjects will complete a 49-day, multi-phase feeding study to evaluate the effect of pea fiber supplementation on gut community structure and features of host biological state (plasma proteome/ metabolome). Subjects will be asked to continue to consume their habitual diet (free diet phase) for 4...
What is the current status of trial NCT04159259?
This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2019-02-13. Estimated completion is 2020-06-01.
What interventions are being tested in trial NCT04159259?
The interventions under investigation include: Low fiber diet (OTHER), Pea Fiber Bar (OTHER).
Who is sponsoring clinical trial NCT04159259?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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