Cold Induced ThermogenesisBorn2BurnNCT05517967
An Examination of Brown Adipose Tissue and Energy Expenditure in Infants
An observational study of Cold Induced Thermogenesis, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 weeks
- Conditions the study is for
- Cold Induced Thermogenesis
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 weeks
- All sexes
- Child
Study population: This study will enroll neonates from two mechanisms: 1) recruited from the greater Baton Rouge area, and 2) recruited from an ongoing prenatal weight maintenance intervention randomized controlled trial (R01DK099175).
Who may be able to join
- aged 0 weeks to less than 3 weeks at visit 1
- be willing to complete MRI procedures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Emily W Flanagan, PhD, 225-763-2828, emily.flanagan@pbrc.edu
Abby D Altazan, MS, 225-763-2801, abby.duhe@pbrc.edu
About this study
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.
Read the detailed description
The developmental origins of obesity begin in utero with growth and differentiation of adipose tissue. Fetal white adipose tissue accretion is highly variable and dependent on the maternal intrauterine environment. Unlike white adipose tissue, brown adipose tissue has a high capacity for thermogenesis. Brown adipose tissue is present at birth and it is believed to support the critical function of thermoregulation in early postnatal life. Therefore, Brown adipose tissue may also influence the development of neonatal energy balance. Similar to white adipose tissue, it is hypothesized that development of Brown adipose tissue in utero is also influenced by maternal factors such as prepregnancy body mass index and gestational weight gain. The research aims of this study to 1) identify maternal and neonatal factors that contribute to neonatal Brown adipose tissue and 2) to identify changes in neonatal Brown adipose tissue and to energy expenditure in response to a mild cold exposure. To achieve these aims, we will conduct a pilot and feasibility study that is cross-sectional, observational study in up to 60 infants 0-3 weeks of age. Using state-of-the-art methodology, we will assess brown adipose tissue, body composition, and resting metabolic rate under thermoneutral and mild-cold stimulated conditions.
- Conditions
- Cold Induced Thermogenesis
- Keywords
- Infant, Energy Expenditure, Indirect Calorimetry, Brown Fat, Neonatal, Magnetic Resonance Imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Brown Adipose Tissue Fat-signal Fraction Difference Between Thermoneutral and Mild-Cold Environment
The difference in the infants' fat-signal fraction (ratio of lipid to water, expressed as a percentage), assessed by Magnetic Resonance Imaging, between a thermoneutral environment and a mild-cold exposure.
Measured: 14 days
Energy Expenditure Difference Between Thermoneutral and Mild-Cold Environment
The difference in the infants' energy expenditure (expressed as kilocalories per day), assessed by room calorimetry, between a thermoneutral environment and a mild-cold exposure.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start17 Aug 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cold Induced ThermogenesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily W. Flanagan, MS, PhD, Pennington Biomedical Research Center
- Investigators
- Emily W Flanagan, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517967
- Sponsor's protocol ID
- PBRC 2021-054
- Acronym
- Born2Burn
- Status last verified
- May 2025
- First submitted
- 24 Aug 2022
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flanagan EW, Altazan AD, Carmichael OT, Hu HH, Redman LM. Practical application of in vivo MRI-based brown adipose tissue measurements in infants. Obesity (Silver Spring). 2021 Oct;29(10):1676-1683. doi: 10.1002/oby.23237.
PubMed 34553508
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of Brown Adipose Tissue and Energy Expenditure in Infants
- ClinicalTrials.gov ID
- NCT05517967
- Acronym / sponsor ID
- Born2Burn / PBRC 2021-054
- Conditions
- Cold Induced Thermogenesis
- Keywords
- Infant, Energy Expenditure, Indirect Calorimetry, Brown Fat, Neonatal, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The developmental origins of obesity begin in utero with growth and differentiation of adipose tissue. Fetal white adipose tissue accretion is highly variable and dependent on the maternal intrauterine environment. Unlike white adipose tissue, brown adipose tissue has a high capacity for thermogenesis. Brown adipose tissue is present at birth and it is believed to support the critical function of thermoregulation in early postnatal life. Therefore, Brown adipose tissue may also influence the development of neonatal energy balance. Similar to white adipose tissue, it is hypothesized that development of Brown adipose tissue in utero is also influenced by maternal factors such as prepregnancy body mass index and gestational weight gain. The research aims of this study to 1) identify maternal and neonatal factors that contribute to neonatal Brown adipose tissue and 2) to identify changes in neonatal Brown adipose tissue and to energy expenditure in response to a mild cold exposure. To achieve these aims, we will conduct a pilot and feasibility study that is cross-sectional, observational study in up to 60 infants 0-3 weeks of age. Using state-of-the-art methodology, we will assess brown adipose tissue, body composition, and resting metabolic rate under thermoneutral and mild-cold stimulated conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 5 weeks
- Sex
- All
- Age groups
- Child
- Study population
- This study will enroll neonates from two mechanisms: 1) recruited from the greater Baton Rouge area, and 2) recruited from an ongoing prenatal weight maintenance intervention randomized controlled trial (R01DK099175).
Key inclusion criteria (2 listed)
- aged 0 weeks to less than 3 weeks at visit 1
- be willing to complete MRI procedures
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brown Adipose Tissue Fat-signal Fraction Difference Between Thermoneutral and Mild-Cold Environment
Time frame: 14 days
The difference in the infants' fat-signal fraction (ratio of lipid to water, expressed as a percentage), assessed by Magnetic Resonance Imaging, between a thermoneutral environment and a mild-cold exposure.
Energy Expenditure Difference Between Thermoneutral and Mild-Cold Environment
Time frame: 14 days
The difference in the infants' energy expenditure (expressed as kilocalories per day), assessed by room calorimetry, between a thermoneutral environment and a mild-cold exposure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Background: PubMed 34553508Flanagan EW, Altazan AD, Carmichael OT, Hu HH, Redman LM. Practical application of in vivo MRI-based brown adipose tissue measurements in infants. Obesity (Silver Spring). 2021 Oct;29(10):1676-1683. doi: 10.1002/oby.23237.
- Individual participant dataSharing planned: No
Related trials for Cold Induced Thermogenesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily W Flanagan, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cold Induced Thermogenesis, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily W Flanagan, PhD (225-763-2828, emily.flanagan@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brown Adipose Tissue Fat-signal Fraction Difference Between Thermoneutral and Mild-Cold Environment (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05517967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.