Palmitate Study - A Method Study

Measurement of Dietary Lipid Oxidation in Toddlers - a Method Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy

Detailed Description

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. These molecules are not dangerous. By collecting several urine samples throughout a 24-hour window (about 7 urine samples or more) after drinking the fat molecules, we will be able to measure how fast your toddler is sending out (excreting) these samples in the urine. This will tell us how fast your toddler is using fat for energy. This will also help determine the best urine collection schedule for studies using this technology.

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72203
      • Arkansas Children's Nutrition Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Healthy
• Male or female
• Toilet trained or not

Exclusion Criteria:

• Diagnosed metabolic disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
How toddlers burn fat	collect urine	24 hours

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute
• Collaborators: Arkansas Children's Nutrition Center

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2020
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 249922

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No