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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: Completed NA study, sponsored by Washington University School of Medicine.

NCT04159259 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 13 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Blood will be drawn for the complete metabolic panel and lipid panel

Interventions

  • OTHER Low fiber diet
  • OTHER Pea Fiber Bar

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2019-02-13
Est. Completion 2020-06-01
Phase NA

What the finished NCT04159259 record still lists

NCT04159259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Low fiber diet is the first listed.

NCT04159259 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04159259's enrollment target sits among peer trials

13 1911th of 2000 higher than 88 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT04159259, the US trial registry maintained by the National Library of Medicine. NCT04159259 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.