Recruiting

Energy Metabolism

Sponsor:

Pennington Biomedical Research Center

Code:

NCT02683473

Conditions

Infant Development

Infant Overnutrition

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Conditions

Infant Development

Infant Overnutrition

Study ID

NCT02683473

Start date

Mar 16, 2016

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

Infants

Infants aged 1-3 months

Primary outcome measure

  • Energy Expenditure by infant metabolic chamber [ Time Frame: Approximately 1 week ]
  • Energy expenditure by doubly labeled water [ Time Frame: Approximately 1 week ]

Central Contacts and Locations

Central contacts

Abby Altazan, M.S.

(225) 763-2801abby.altazan@pbrc.edu

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Abby Altazan, M.S.

(225) 763-2801abby.altazan@pbrc.edu

Principal Investigator:

Leanne M Redman, Ph.D.

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pennington Biomedical Research Center on 2026-08-10.