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Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome (FIB)

NCT04159259 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-12-27

No results posted yet for this 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.

Conditions

  • Microbial Colonization

Interventions

OTHER

Low fiber diet

Participants will be provided with a low fiber diet in the form of packed out meals and snacks for 24 days in total (days 5-14 and days 36-49)

OTHER

Pea Fiber Bar

Participants will be provided with a low fiber diet plus 1-3 daily pea fiber bars from days 15-35

OTHER

Low fiber diet

Participants will return to the low fiber diet for days 36-49- this phase is the same as phase 1.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Samuel Klein, MD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-13
Primary Completion
2019-08-30
Completion
2020-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04159259 on ClinicalTrials.gov