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Prebiotics, Gut Microbiota, and Cardiometabolic Health

NCT02346838 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-03-27

No results posted yet for this study

Summary

Forty-eight prediabetic men and women (50-75 years of age) will participate in a 6-week feeding study in which they will randomized to receive either 10 g/day of inulin or placebo. All subjects will be fed an isocaloric diet (50% carbohydrate, 35% fat, 15% protein,) controlled for micronutrient content for 6 weeks to avoid the potential confound of individual differences in diet on gut microbiota. Measurements of intestinal permeability, insulin sensitivity, and skeletal muscle metabolic flexibility will be made prior to and following the controlled feeding period. Stool samples will be collected to assess gut microbial communities.

Conditions

Interventions

DIETARY_SUPPLEMENT

Inulin

The treatment will be mixed in orange juice or other beverage and will be consumed at breakfast each day in our metabolic kitchen.

DIETARY_SUPPLEMENT

Placebo

The placebo will be mixed in orange juice or other beverage and will be consumed at breakfast each day in our metabolic kitchen.

Sponsors & Collaborators

  • Virginia Polytechnic Institute and State University

    lead OTHER

Principal Investigators

  • Kevin P Davy, PhD · Virginia Polytechnic and State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-12-31
Completion
2018-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02346838 on ClinicalTrials.gov