Clinical trial NCT02683473: Measurement of Energy Metabolism in Infants
Official title: Measurement of Energy Metabolism in Infants: BabyEE Pilot
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infant Development
Infant Overnutrition
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Full-term infants aged 1 to 3 months who are exclusively fed breast milk and/or infant formula will be recruited

Brief summary: The purpose of this study is to measure energy expenditure during the first 3 months of life in infants.

Detailed description: This study intends to establish the feasibility of undertaking comprehensive metabolic phenotyping in infants. The overarching aim is to complete a prospective assessment of energy expenditure in the new infant metabolic chamber approximately one week apart to determine the accuracy and precision of infant protocols related to energy metabolism (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis) and physical activity. This cross-sectional study will answer the following questions:

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?

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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)

Primary outcomes:
measure: Energy Expenditure by infant metabolic chamber
timeFrame: Approximately 1 week
measure: Energy expenditure by doubly labeled water
timeFrame: Approximately 1 week
Secondary outcomes:
measure: Percent body fat
timeFrame: Approximately 1 week
measure: Physical activity counts
timeFrame: Approximately 1 week
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Leanne M Redman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: