Fiber Blends and Gut Microbiota (FB) (FB)

Effect of Dietary Supplementation With Fiber Blends on the Gut Microbiota and Host Metabolome and Proteome

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.

Study Overview

• Status: Completed
• Conditions: Gut Microbiome
• Intervention / Treatment: Other: Two fiber-blend snack and four fiber-blend snack

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of fiber blend snacks on gut microbiota	Stool samples will be analyzed to determine changes in type and number of gut microbiota.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2019
• Primary Completion (Actual): November 21, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 201907041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No