Status:
COMPLETED
Fiber Blends and Gut Microbiota (FB)
Lead Sponsor:
Washington University School of Medicine
Conditions:
Gut Microbiome
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ...
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 biol...
Eligibility Criteria
Inclusion
- BMI ≥25.0 and ≤35.0 kg/m2
- ≥18 and ≤60 years
Exclusion
- 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.
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04101344
Start Date
August 26 2019
End Date
June 1 2020
Last Update
December 27 2024
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110