Fiber Blends and Gut Microbiota (FB)

Gut Microbiome Clinical Trial

— FB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04101344
• Other study ID #: 201907041
• Status: Completed
• Phase: N/A
• Start date: August 26, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 1, 2020
• Est. primary completion date: November 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gut Microbiome

Intervention

Other:
• Two 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).

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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