Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2019-08-26
2020-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* ≥18 and ≤60 years
Exclusion Criteria
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Other Identifiers
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201907041
Identifier Type: -
Identifier Source: org_study_id