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OpenTrials
Completed

NCT Number: NCT04101344

Fiber Blends and Gut Microbiota (FB)

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Two fiber-blend snack and four fiber-blend snack

Other

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).

Primary outcomes

  1. Effect of fiber blend snacks on gut microbiota

    Time frame: 1 year

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

Secondary outcomes

  1. Effect of fiber blend snacks in blood and urine

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: FB

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Sep 24, 2019
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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