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NCT03078283 · ClinicalTrials.gov registry record · NA

Food Effects on the Gut Microbiota

A NA study, sponsored by Washington University School of Medicine.

Completed
Registry status
NA
Development phase
24
Enrollment target

NCT03078283 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 24 participants.

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The verdict

NCT03078283, a NA study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
NA
Development phase
24 participants
Enrollment target

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.

Interventions

  • OTHER high-fiber food type

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2017-04-10
Est. Completion 2019-09-30
Phase NA

What the Registry Record Tells You About NCT03078283

The ClinicalTrials.gov registry entry for NCT03078283 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which high-fiber food type is the first listed.

NCT03078283 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03078283 about?

NCT03078283 is a clinical study titled "Food Effects on the Gut Microbiota". 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 co...

What is the current status of trial NCT03078283?

This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2017-04-10. Estimated completion is 2019-09-30.

What interventions are being tested in trial NCT03078283?

The interventions under investigation include: high-fiber food type (OTHER).

Who is sponsoring clinical trial NCT03078283?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.