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Food Effects on the Gut Microbiota

NCT03078283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-01-22

No results posted yet for this study

Summary

This is a small-scale study of the effects on microbes in the human gut of adding high-fiber snack foods to usual diet. The snack foods are being provided by Mondelez International, Inc. Eight pairs of dizygotic twins, discordant or concordant for obesity, will participate in the study. They will complete 3 successive experiments in which their regular diet is supplemented by consumption, over a 6-week period, of high-fiber snack foods. Each experiment will involve (i) two weeks consuming regular diet (fecal sample collected weekly); (ii) one week consuming one snack food per day (approximately 7 g fiber, collection of all fecal samples), (iii) one week consuming two snack foods per day (approximately 14 g fiber, collection of all fecal samples), (iv) four weeks consuming three snack foods per day (approximately 20 g fiber, collection of all fecal samples); and (v) two weeks consuming only regular diet (weekly collection of fecal sample). For each experiment, participants will also provide a fasting blood sample during the free diet phase at the end of the week just before initiation of snack consumption, and a fasting blood sample at the end of the last week of snack consumption. Participants will also collect one first morning urine sample weekly throughout the study. During week 2, participants will also collect first morning urine samples for 3 consecutive days. Similarly, they will collect first morning urine samples for the last 3 consecutive days of the last week of snack consumption. The study will test the effects of the different fiber-rich snacks on the composition and metabolic properties of the gut microbial community in lean and obese subjects.

Conditions

  • Gut Microbial Responses to Dietary Fiber

Interventions

OTHER

high-fiber food type

In 3 successive experiments, usual diet will be supplemented with snack foods containing fiber of plant, fruit or grain origin.

Sponsors & Collaborators

  • Mondelēz International, Inc.

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Jeffrey I Gordon, MD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
31 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2018-12-31
Completion
2019-09-30

Countries

  • United States

Study Locations

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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 NCT03078283 on ClinicalTrials.gov