Infant Body Composition and MetabolismSPROUTNCT07096011
Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants
An observational study of Infant Body Composition and Metabolism and Metabolism, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this research study is to understand how infants metabolize different meals and to develop clinical tools which identify infants as having two different phenotypes. The phenotypes are the 1) metabolic "thriftiness" and 2) the metabolic flexibility. Read more about this study
- Who is it for?
- Ages 2 to 16 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Body Composition and Metabolism, Metabolism, Energy Expenditure
- What is being tested?
- Meal Test - Human Milk and Meal Test - Infant Formula
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2025to May 2027
- 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 2 to 16 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Up to 40 infants who are less than 17 weeks will be recruited to participate in this study.
Who may be able to join
- Aged 2 weeks to less than 17 weeks at screening
- Being fed human milk as a primary source of food
- Be willing to consume one meal of infant formula
- Be willing to complete a DXA measurement
Who cannot join
- Unable to complete the screening visit and two clinic visits within 14 days
- Born with health conditions that would render procedures unsafe
- Born earlier than 35 days and 0 weeks gestation
- Eating supplemental foods
- Physician diagnosed feeding difficulties that may require a special type of nipple for bottle feeding
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
About this study
Official title: Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants: A Pilot Study
The purpose of this research study is to understand how infants metabolize different meals and to develop clinical tools which identify infants as having two different phenotypes. The phenotypes are the 1) metabolic "thriftiness" and 2) the metabolic flexibility.
Read the detailed description
The purpose of this research study is to understand how infants metabolize different meals and to develop clinical tools which identify infants as having two different phenotypes. This will be accomplished by providing two meal test stimuli to infant participants (human milk and infant formula). Energy expenditure and respiratory exchange ratio will be obtained before and after the meals to calculate the delta in both. From there, two phenotypes will be identified. The first phenotypes is metabolic "thriftiness", which will be defined by the energy expenditure after consuming two standard meals. The second phenotype is the degree of metabolic flexibility and will be defined by substrate oxidation (using respiratory exchange ratio) following two standard meals.
- Conditions
- Infant Body Composition and Metabolism, Metabolism, Energy Expenditure, Infant Formula, Human Milk, Breast Milk, Metabolic Flexibility
- Being tested
- Meal Test - Human Milk, Meal Test - Infant Formula
- Keywords
- infant, metabolism, energy expenditure, infant formula, breast milk, human milk, thrifty phenotype, metabolic flexibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal Test - Human MilkOther
Infants will be fed a mixed meal test (meal challenge test) of human milk from his/her human milk donor (e.g., mother). Since all infants enrolled in the study consume human milk as a primary food source, this meal challenge test represents their standard meal, at a larger size. The meal test is provided inside a metabolic chamber to measure energy expenditure (VCO2 and VO2) before and after the meal. The amount of human milk that the infant is fed is estimated using the age and sex specific equations from the 2023 DRI for infants aged 0-2 years. Infants will be provided 20% of their predicted energy needs, which is equivalent to between 4-6 ounces of food for most infants of this age. The caloric content for human milk is be estimated at 20 kcals/ounce.
Meal Test - Infant FormulaOther
Infants will be fed a mixed meal test (meal challenge test) of ready-to-feed infant formula. Since all infants enrolled in the study consume human milk as a primary food source, this meal challenge test represents a meal different from their habitual food intake and is a standard meal that all participants receive. The meal test is provided inside a metabolic chamber to measure energy expenditure (VCO2 and VO2) before and after the meal. The amount of infant formula that the infant is fed is estimated using the age and sex specific equations from the 2023 DRI for infants aged 0-2 years. Infants will be provided 20% of their predicted energy needs, which is equivalent to between 4-6 ounces of food for most infants of this age. The caloric content for the ready-to-feed infant formula is 20 kcals/ounce.
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure difference from baseline to postprandial
Percent difference from baseline to postprandial energy expenditure
Measured: 60 minutes
Energy expenditure difference from baseline to postprandial (2)
Absolute difference between baseline and postprandial energy expenditure
Measured: 60 minutes
Secondary outcomes (2)
Thrifty and Spendthrift Phenotypes
Number of infants with a thrifty and spendthrift phenotype
Measured: 60 minutes
Metabolic flexibility
Difference in respiratory exchange ratio from baseline to postprandial
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start28 Jul 2025
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Body Composition and MetabolismStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096011
- Sponsor's protocol ID
- 2025-026
- Acronym
- SPROUT
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants: A Pilot Study
- ClinicalTrials.gov ID
- NCT07096011
- Acronym / sponsor ID
- SPROUT / 2025-026
- Conditions
- Infant Body Composition and Metabolism, Metabolism, Energy Expenditure, Infant Formula, Human Milk, Breast Milk, Metabolic Flexibility
- Keywords
- infant, metabolism, energy expenditure, infant formula, breast milk, human milk, thrifty phenotype, metabolic flexibility
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 31 Jul 2025 (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.
The purpose of this research study is to understand how infants metabolize different meals and to develop clinical tools which identify infants as having two different phenotypes. The phenotypes are the 1) metabolic "thriftiness" and 2) the metabolic flexibility.
Detailed description
The purpose of this research study is to understand how infants metabolize different meals and to develop clinical tools which identify infants as having two different phenotypes. This will be accomplished by providing two meal test stimuli to infant participants (human milk and infant formula). Energy expenditure and respiratory exchange ratio will be obtained before and after the meals to calculate the delta in both. From there, two phenotypes will be identified. The first phenotypes is metabolic "thriftiness", which will be defined by the energy expenditure after consuming two standard meals. The second phenotype is the degree of metabolic flexibility and will be defined by substrate oxidation (using respiratory exchange ratio) following two standard meals.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 16 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Up to 40 infants who are less than 17 weeks will be recruited to participate in this study.
Key inclusion criteria (4 listed)
- Aged 2 weeks to less than 17 weeks at screening
- Being fed human milk as a primary source of food
- Be willing to consume one meal of infant formula
- Be willing to complete a DXA measurement
Key exclusion criteria (5 listed)
- Unable to complete the screening visit and two clinic visits within 14 days
- Born with health conditions that would render procedures unsafe
- Born earlier than 35 days and 0 weeks gestation
- Eating supplemental foods
- Physician diagnosed feeding difficulties that may require a special type of nipple for bottle feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal Test - Human MilkInfants will be fed a mixed meal test (meal challenge test) of human milk from his/her human milk donor (e.g., mother). Since all infants enrolled in the study consume human milk as a primary food source, this meal challenge test represents their standard meal, at a larger size. The meal test is provided inside a metabolic chamber to measure energy expenditure (VCO2 and VO2) before and after the meal. The amount of human milk that the infant is fed is estimated using the age and sex specific equations from the 2023 DRI for infants aged 0-2 years. Infants will be provided 20% of their predicted energy needs, which is equivalent to between 4-6 ounces of food for most infants of this age. The caloric content for human milk is be estimated at 20 kcals/ounce. | Other | – |
| Meal Test - Infant FormulaInfants will be fed a mixed meal test (meal challenge test) of ready-to-feed infant formula. Since all infants enrolled in the study consume human milk as a primary food source, this meal challenge test represents a meal different from their habitual food intake and is a standard meal that all participants receive. The meal test is provided inside a metabolic chamber to measure energy expenditure (VCO2 and VO2) before and after the meal. The amount of infant formula that the infant is fed is estimated using the age and sex specific equations from the 2023 DRI for infants aged 0-2 years. Infants will be provided 20% of their predicted energy needs, which is equivalent to between 4-6 ounces of food for most infants of this age. The caloric content for the ready-to-feed infant formula is 20 kcals/ounce. | Other | – |
Primary outcome
Energy expenditure difference from baseline to postprandial
Time frame: 60 minutes
Percent difference from baseline to postprandial energy expenditure
Energy expenditure difference from baseline to postprandial (2)
Time frame: 60 minutes
Absolute difference between baseline and postprandial energy expenditure
2 secondary outcomes
Thrifty and Spendthrift Phenotypes
Time frame: 60 minutes
Metabolic flexibility
Time frame: 60 minutes
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 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Infant Body Composition and Metabolism and Metabolism, 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 4 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 22 Aug 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 Abby A Altazan, MS (225-763-2801, abby.altazan@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure difference from baseline to postprandial (time frame: 60 minutes). 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?
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 22 Aug 2025.