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NCT03612479 · ClinicalTrials.gov registry record · NA

Response of the Gut Microbiome and Circulating Metabolome to Diet in Children: Ancillary Study to KIDFIT (NCT03405246)

A NA study, sponsored by Northwestern University.

Completed
Registry status
NA
Development phase
46
Enrollment target

NCT03612479: Completed NA study, sponsored by Northwestern University.

NCT03612479 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 46 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03612479, a NA study, has completed, sponsored by Northwestern University.

COMPLETED
Registry status
NA
Development phase
46 participants
Enrollment target

Study Summary

This is an ancillary study to KIDFIT (NCT03405246). KIDFIT tests whether preschool-age children, born to overweight or obese mothers, respond to a healthy DASH diet intervention with better cardiovascular health. This ancillary study to KIDFIT investigates how the children's gut microbiomes (bacteria in the intestines) and blood metabolomes (small molecules in the blood) are affected by the DASH diet intervention, and how the microbiome and metabolome relate to the children's cardiovascular health over time. The investigators hypothesize that (1) the DASH diet will modify the gut microbiome and blood metabolome, (2) the gut microbiome and blood metabolome will be related to each other, and (3) the microbiome and metabolome will be associated with the children's cardiovascular health profiles (things like weight, body fat, blood pressure, and cholesterol).

Primary Outcome

abundances of gut microbial taxa, communities, and metabolic pathways activity

Interventions

  • BEHAVIORAL KIDFIT Healthy
  • BEHAVIORAL KIDFIT Safe

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2018-07-10
Est. Completion 2020-11-16
Phase NA
Northwestern University

1,209 total trials

What the finished NCT03612479 record still lists

NCT03612479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which KIDFIT Healthy is the first listed.

NCT03612479 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03612479 about?

NCT03612479 is a clinical study titled "Response of the Gut Microbiome and Circulating Metabolome to Diet in Children: Ancillary Study to KIDFIT (NCT03405246)". This is an ancillary study to KIDFIT (NCT03405246). KIDFIT tests whether preschool-age children, born to overweight or obese mothers, respond to a healthy DASH diet intervention with better cardiovascular health. This ancillary study to KIDFIT investigates how the children's gut microbiomes (bacter...

What is the current status of trial NCT03612479?

This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2018-07-10. Estimated completion is 2020-11-16.

What interventions are being tested in trial NCT03612479?

The interventions under investigation include: KIDFIT Healthy (BEHAVIORAL), KIDFIT Safe (BEHAVIORAL).

Who is sponsoring clinical trial NCT03612479?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03612479's enrollment target sits among peer trials

46 1402nd of 2000 higher than 590 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 NCT03612479, the US trial registry maintained by the National Library of Medicine. NCT03612479 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.