NCT02340286

Brief Summary

The purpose of this study is to determine energy expenditure and fat oxidation in 2 year old children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

October 20, 2014

Last Update Submit

December 18, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • To determine total energy expenditure in 2 year old children

    Doubly labeled water is administered to 2 year old children and urine is collected at different time points.

    15 days

  • To determine fat oxidation in children

    Deuterated palmitate is administered and urine is collected at different time points.

    2-6 hours

Eligibility Criteria

Age2 Years - 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

10 toddlers born from mothers of the Glowing study (NCT01131117)

You may qualify if:

  • years of age
  • Mother is a participant in the Glowing study (protocol NCT01131117)
  • Healthy without taking medication that can affect study outcomes, as determined by the PI.

You may not qualify if:

  • None listed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72203, United States

Location

Study Design

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

Study Record Dates

First Submitted

October 20, 2014

First Posted

January 16, 2015

Study Start

September 1, 2014

Primary Completion

May 1, 2015

Study Completion

December 1, 2017

Last Updated

December 20, 2023

Record last verified: 2023-12

Locations

US(1)