Measurement of Energy Metabolism in Infants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-3
SponsorPennington Biomedical Research Center
About this trial
The purpose of this study is to measure energy expenditure during the first 3 months of life in infants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy, full-term infant
Aged 1 month (28 days) to 3 months (12 weeks, 6 days) at the first visit
Exclusively fed breast milk and/or infant formula
Willing to accept doubly-labeled water
Disqualifiers
Unable to complete 3 clinic visits within about 14 days at Pennington Biomedical Research Center
Born preterm (< 37 weeks gestation)
Congenital abnormality or disability
Gastric reflux
Trial population
Full-term infants aged 1 to 3 months who are exclusively fed breast milk and/or infant formula will be recruited
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
70 Participants
are grouped into 1 trial groupGroup A: Infants
Trial outcomes
Primary outcomes
1
Energy Expenditure by infant metabolic chamber
Energy expenditure by infant metabolic chamber measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.
Time frame
Approximately 1 week2
Energy expenditure by doubly labeled water
Energy expenditure by doubly labeled water measured over approximately 7 days in infants aged 1-3 months
Time frame
Approximately 1 weekSecondary outcomes
1
Percent body fat
Percent body fat by PEA POD measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.
Time frame
Approximately 1 week2
Physical activity counts
Physical activity counts by Actigraph accelerometer measured over approximately 7 days in infants aged 1-3 months.
Time frame
Approximately 1 weekSponsors and contacts
Click on the lead sponsor to view all of their trials.
Pennington Biomedical Research Center
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov