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Fiber Blends and Gut Microbiota (FB)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04101344
Acronym
FB
Enrollment
14
Registered
2019-09-24
Start date
2019-08-26
Completion date
2020-06-01
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiome

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.

Interventions

OTHERTwo 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).

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Effect of fiber blend snacks on gut microbiota1 yearStool samples will be analyzed to determine changes in type and number of gut microbiota.

Secondary

MeasureTime frameDescription
Effect of fiber blend snacks in blood and urine1 yearBlood and urine samples will be analyzed to assess how many proteins and metabolites are present in these samples before and after fiber snack supplementation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026