Measurement of Energy Metabolism in Infants (BabyEE Pilot)

Measurement of Energy Metabolism in Infants: BabyEE Pilot

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

Study Overview

• Status: Recruiting
• Conditions: Infant Development; Infant Overnutrition

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 Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Abby Altazan, M.S.; Phone Number: (225) 763-2801; Email: abby.altazan@pbrc.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Pennington Biomedical Research Center
      • Principal Investigator: Leanne M Redman, Ph.D.
      • Contact: Abby Altazan, M.S.; Phone Number: 225-763-2801; Email: abby.altazan@pbrc.edu
      • Sub-Investigator: Eric Ravussin, Ph.D.
      • Sub-Investigator: Abby Duhé Altazan, M.S.
      • Sub-Investigator: Daniel Hsia, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: Yes

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Infants; Infants aged 1-3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately 1 week
Energy expenditure by doubly labeled water	Energy expenditure by doubly labeled water measured over approximately 7 days in infants aged 1-3 months	Approximately 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately 1 week
Physical activity counts	Physical activity counts by Actigraph accelerometer measured over approximately 7 days in infants aged 1-3 months.	Approximately 1 week

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Leanne M Redman, Ph.D., Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2016
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: February 10, 2016
• First Posted (Estimated): February 17, 2016

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Nutritional and Metabolic Diseases; Infant Nutrition Disorders
• Other Study ID Numbers: PBRC 2015-061; P30DK072476-10 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO