Measurement of Energy Metabolism in Infants

Recruiting

• Conditions: Infant Development; Infant Overnutrition

• Registration Number: NCT02683473
• Lead Sponsor: Pennington Biomedical Research Center

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?

Study Timeline

• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-17
• Study Start: 2016-03-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Energy Expenditure by infant metabolic chamber	Approximately 1 week	Energy expenditure by infant metabolic chamber measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.
Energy expenditure by doubly labeled water	Approximately 1 week	Energy expenditure by doubly labeled water measured over 7 days in infants aged 1-3 months

Secondary Outcome Measures

Name	Time	Method
Percent body fat	Approximately 1 week	Percent body fat by PEA POD measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.
Physical activity counts	Approximately 1 week	Physical activity counts by Actigraph accelerometer measured over 7 days in infants aged 1-3 months.

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States