NCT04408833

Brief Summary

The purpose of this research is to measure how toddlers burn fat after drinking milk that has some fat molecules that can be tracked based on how heavy they are.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

August 21, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 7, 2025

Status Verified

January 1, 2025

Enrollment Period

4.7 years

First QC Date

May 26, 2020

Last Update Submit

February 5, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • How toddlers burn fat

    collect urine

    24 hours

Eligibility Criteria

Age23 Months - 25 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

10 toddlers approximately two years of age from ongoing studies or as a new participant from the community

You may qualify if:

  • Healthy
  • Male or female
  • Toilet trained or not

You may not qualify if:

  • Diagnosed metabolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine

Study Officials

  • Elisabet Borsheim, PhD

    Arkansas Children's Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2020

First Posted

May 29, 2020

Study Start

August 21, 2020

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

February 7, 2025

Record last verified: 2025-01

Locations

US(1)