Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2016-03-16
2025-06-30
Brief Summary
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Detailed Description
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1. What is the test re-test reliability of measuring energy expenditure (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis) in an infant under the same conditions, 5-7 days apart?
2. What is the reliability of 24h energy expenditure estimated by the infant metabolic chamber in comparison to a 7-day doubly labeled water study?
3. How do energy expenditure measurements in infants need to be adjusted to account for variability in infant size and body composition?
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Infants
Infants aged 1-3 months
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Born preterm (\< 37 weeks gestation)
* Congenital abnormality or disability
* Gastric reflux
* Acute illness within 7 days of the study (fever, diarrhea)
* Use of medications to treat a chronic condition (does not include use of vitamin supplements or PRN medication for flatulence or reflux such as Pepcid)
1 Month
3 Months
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Pennington Biomedical Research Center
OTHER
Responsible Party
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Leanne Redman
Principal Investigator
Principal Investigators
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Leanne M Redman, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Center
Locations
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Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Countries
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Other Identifiers
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PBRC 2015-061
Identifier Type: -
Identifier Source: org_study_id
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