Recruiting

Observational StudyAn Examination of Brown Adipose Tissue and Energy Expenditure in Infants

Sponsor:

Pennington Biomedical Research Center

Code:

NCT05517967

Conditions

Cold Induced Thermogenesis

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Excess fetal adipose tissue growth during intrauterine development increases future obesity risk. Development of brown adipose tissue, a highly thermogenic organ in utero, may affect postnatal energy expenditure, thus influencing obesity risk. This pilot research study is designed to understand the developmental origins of energy balance by examining maternal and neonatal factors that influence neonatal brown adipose tissue and to quantify its physiological relevance to energy expenditure in human neonates.

Conditions

Cold Induced Thermogenesis

Study ID

NCT05517967

Start date

Aug 17, 2022

Status verified date

May, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

aged 0 weeks to less than 3 weeks at visit 1
be willing to complete MRI procedures

Exclusion Criteria:

Unable to complete two clinic visits within 14 days
Born with health conditions that would render the procedures unsafe
Born earlier than 36 and 0 days gestation
Taken a steroid drug since birth
Implanted metal or electronic objects that render MRI unsafe

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Brown Adipose Tissue Fat-signal Fraction Difference Between Thermoneutral and Mild-Cold Environment [ Time Frame: 14 days ]
Energy Expenditure Difference Between Thermoneutral and Mild-Cold Environment [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Emily W Flanagan, PhD

225-763-2828 emily.flanagan@pbrc.edu

Abby D Altazan, MS

225-763-2801 abby.duhe@pbrc.edu

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Emily W Flanagan, PhD

225-763-2828 emily.flanagan@pbrc.edu

Abby D Altazan, MS

225-763-2801 abby.duhe@pbrc.edu

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

May 31, 2025

Last verified

May, 2025

Keywords

Infant
Energy Expenditure
Indirect Calorimetry
Brown Fat
Neonatal
Magnetic Resonance Imaging

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 2025-05-31.