NCT02414867

Brief Summary

The purpose of the 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
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

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

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 25, 2024

Status Verified

December 1, 2023

Enrollment Period

2.8 years

First QC Date

April 8, 2015

Last Update Submit

November 22, 2024

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 2 year old children

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

    2-6 hours

Study Arms (2)

1

Normal weight mothers

2

Overweight/Obese mothers

Eligibility Criteria

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

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

You may qualify if:

  • years of age
  • Mother is a participant of the Glowing study (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, 72202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine collected

Study Officials

  • Elisabet Borsheim, PhD

    Arkansas Children's Nutrition Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 13, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 25, 2024

Record last verified: 2023-12

Locations

US(1)