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NCT Number: NCT02683473

Measurement of Energy Metabolism in Infants

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

Recruiting

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Key information

Age range

1 month–3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location status: Recruiting

Location contact

Abby Altazan, M.S.

CONTACT

[email protected]

225-763-2801

Abby Duhé Altazan, M.S.

SUB_INVESTIGATOR

Daniel Hsia, M.D.

SUB_INVESTIGATOR

Eric Ravussin, Ph.D.

SUB_INVESTIGATOR

Leanne M Redman, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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:

  • 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?
  • What is the reliability of 24h energy expenditure estimated by the infant metabolic chamber in comparison to a 7-day doubly labeled water study?
  • How do energy expenditure measurements in infants need to be adjusted to account for variability in infant size and body composition?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Energy Expenditure by infant metabolic chamber

    Time frame: 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.

  2. Energy expenditure by doubly labeled water

    Time frame: Approximately 1 week

    Energy expenditure by doubly labeled water measured over approximately 7 days in infants aged 1-3 months

Secondary outcomes

  1. Percent body fat

    Time frame: 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.

  2. Physical activity counts

    Time frame: Approximately 1 week

    Physical activity counts by Actigraph accelerometer measured over approximately 7 days in infants aged 1-3 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Abby Altazan, M.S.

CONTACT

[email protected]

(225) 763-2801

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Measurement of Energy Metabolism in Infants: BabyEE Pilot

Acronym: BabyEE Pilot

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2016
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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