Fiber Blends and Gut Microbiota (FB)

Not Applicable

Completed

• Conditions: Gut Microbiome
• Interventions: Other: Two fiber-blend snack and four fiber-blend snack

• Registration Number: NCT04101344
• Lead Sponsor: Washington University School of Medicine

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-08-26
• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-24
• Primary Completion: 2019-11-21
• Study Completion: 2020-06-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fiber-blend	Two fiber-blend snack and four fiber-blend snack	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effect of fiber blend snacks in blood and urine	1 year	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States