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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: Completed NA study, sponsored by Washington University School of Medicine.

NCT03078283 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Sequencing bacterial 16S rRNA amplicons plus shotgun sequencing of fecal community DNA to identify effects of fiber-enriched foods on bacterial community and gene representation; mass spectrometry of products of gut microbial community metabolism.

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 finished NCT03078283 record still lists

NCT03078283 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

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

NCT03078283 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03078283's enrollment target sits among peer trials

24 1736th of 2000 higher than 246 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03078283, the US trial registry maintained by the National Library of Medicine. NCT03078283 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.