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Clinical Trials/NCT04101344
NCT04101344
Completed
Not Applicable

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

Washington University School of Medicine1 site in 1 country14 target enrollmentAugust 26, 2019
ConditionsGut Microbiome

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gut Microbiome
Sponsor
Washington University School of Medicine
Enrollment
14
Locations
1
Primary Endpoint
Effect of fiber blend snacks on gut microbiota
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 26, 2019
End Date
June 1, 2020
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Effect of fiber blend snacks in blood and urine(1 year)

Study Sites (1)

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