Fiber Blends and Gut Microbiota (FB)

NCT04101344 | Completed

• 1 other identifier: 201907041
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect of fiber blend snacks in blood and urine

  1 year

Study Arms (1)

Fiber-blend

EXPERIMENTAL

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

Interventions

Two fiber-blend snack and four fiber-blend snack OTHER

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).

Fiber-blend

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI ≥25.0 and ≤35.0 kg/m2
• ≥18 and ≤60 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: August 26, 2019
• Primary Completion: November 21, 2019
• Study Completion: June 1, 2020
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

US (1)