Fiber Blends and Gut Microbiota (FB)

Study 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.

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

Conditions
-----------------
Gut Microbiome

Intervention / Treatment
-----------------
* Other: Two fiber-blend snack and four fiber-blend snack


Participation Criteria
=================
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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fiber-blend<br>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. | Other: Two fiber-blend snack and four fiber-blend snack<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of fiber blend snacks on gut microbiota | Stool samples will be analyzed to determine changes in type and number of gut microbiota. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of fiber blend snacks in blood and urine | Blood and urine samples will be analyzed to assess how many proteins and metabolites are present in these samples before and after fiber snack supplementation. | 1 year |