Status:
COMPLETED
Assessing the Dose Response of a Lead Fiber Snack Prototype
Lead Sponsor:
Washington University School of Medicine
Conditions:
Microbiota
Gastrointestinal Microbiome
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Aim: To test the effects of a fiber-blend containing snack prototype in an escalating dose regimen (from 1 to 3 servings per day over a period of 6 weeks) on the configuration and gene content of the ...
Eligibility Criteria
Inclusion
- BMI ≥25.0 and ≤35.0 kg/m2
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 less than 5 years
- Major psychiatric illness
- Inflammatory gastrointestinal disease
- Pregnant or lactating women
- Use of medications that are known to affect the study outcome measures
- Use of medications or supplements known to affect composition of the gut microbiota within the last 30 days (e.g. antibiotics)
- Bowel movements less than 3 times per week
- Vegans, vegetarians, and those with allergies, aversions, or sensitivities to foods provided in the study
- Persons that are not able to grant voluntary informed consent
- Persons who are unable or unwilling to follow the study protocol or who the research team deems not an appropriate candidate for the study.
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04729816
Start Date
February 22 2021
End Date
November 15 2021
Last Update
December 27 2024
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110