CClinicalTrials.gg
CompletedNCT04101344FBUpdated Dec 27, 2024

Fiber Blends and Gut Microbiota (FB)

An interventional study of Two fiber-blend snack and four fiber-blend snack in Gut Microbiome, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The purpose of this research study is to determine whether consuming snacks containing different blends of dietary fibers alters the type and number of bacteria found in your gut and improves markers of overall health.

Read the detailed description

All subjects will complete a 47-day, multi-phase feeding study to evaluate the effect of two snack prototypes containing two different fiber blends on gut community structure and features of host biological state (plasma proteome/ metabolome). The information gained from this work will increase our understanding of the importance of specific dietary fibers in manipulating the composition of the gut microbiota in ways that may improve our metabolic health.

02

Conditions studied

  • Gut Microbiome
03

In context

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • BMI ≥25.0 and ≤35.0 kg/m2
  • ≥18 and ≤60 years

Exclusion criteria

Exclusion Criteria:

  • previous bariatric surgery
  • significant organ system dysfunction (e.g., diabetes, severe pulmonary, kidney, liver or cardiovascular disease)
  • cancer or cancer that has been in remission for \<5 years
  • major psychiatric illness
  • inflammatory gastrointestinal disease
  • pregnant or lactating women
  • use of medications that are known to affect the study outcome measures and that cannot be temporarily discontinued for this study
  • use of medications known to affect the composition of the gut microbiota within the last 30 days (most notably antibiotics)
  • bowel movements \<3 times per week
  • vegans, vegetarians, those with lactose intolerance and/or severe allergies/aversions/sensitivities to foods and ingredients included in the prescribed meal plan
  • persons who are not able to grant voluntary informed consent
  • persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Fiber-blend

    All participants will receive a two fiber-blend snack and then a four fiber-blend snack. Stool, blood, and urine will be monitored for changes throughout the study.

    Other: Two fiber-blend snack and four fiber-blend snack

Interventions

  • OtherTwo fiber-blend snack and four fiber-blend snack

    All subjects will complete a 47-day, multi-phase feeding study to evaluate the effect of two snack prototypes containing two different fiber blends on gut community structure and features of host biological state (plasma proteome/ metabolome).

06

What researchers measure

Primary outcomes

  1. Effect of fiber blend snacks on gut microbiota

    Stool samples will be analyzed to determine changes in type and number of gut microbiota.

    Time frame: 1 year

Secondary outcomes

  1. Effect of fiber blend snacks in blood and urine

    Blood and urine samples will be analyzed to assess how many proteins and metabolites are present in these samples before and after fiber snack supplementation.

    Time frame: 1 year

07

Study locations

1 site
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04101344
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Sep 24, 2019
Start date
Aug 26, 2019
Primary completion
Nov 21, 2019
Completion
Jun 1, 2020
Last update
Dec 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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