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Fiber Blends and Gut Microbiota (FB)

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The Washington University

Status

Completed

Conditions

Gut Microbiome

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04101344
201907041

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

Fiber-blend
Experimental group
Description:
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.
Treatment:
Other: Two fiber-blend snack and four fiber-blend snack

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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