Metabolic phenotypes linked to obesity risk in young infants
Official title: Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants: A Pilot Study
Run by Pennington Biomedical Research Center · NCT07096011 · Data updated 2026-11-12
This project will test whether young infants show two different metabolic patterns—'thrifty' or 'flexible'—after feeding human milk and infant formula.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Weeks to 16 Weeks |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Pennington Biomedical Research Center Academic / other |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Status | Recruiting |
| Started | July 28, 2025 |
| Main results expected | April 2027 |
| Study ends | May 2027 |
| Registry record updated | August 22, 2025 |
| Trial ID | NCT07096011 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are infants 2 to less than 17 weeks old who are primarily fed human milk, can take one formula meal for testing, and can complete clinic visits and a DXA scan.
✕Probably not a fit
Infants born before 35 weeks gestation, already eating supplemental foods, with physician-diagnosed feeding difficulties, or with health conditions that make procedures unsafe are unlikely to benefit from or be eligible for this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational research measures infants' energy expenditure and respiratory exchange ratio before and after two standardized meal tests (human milk and infant formula). Changes in energy use and substrate oxidation will be calculated from pre- and post-meal measurements, and a DXA scan will assess body composition. Investigators will use those post-meal responses to classify infants as having metabolic 'thriftiness' (lower postprandial energy expenditure) or metabolic 'flexibility' (larger shifts in substrate oxidation). The protocol enrolls infants aged 2 to less than 17 weeks who are primarily breastfed and willing to take one formula meal, with visits at the Pennington Biomedical Research Center in Baton Rouge.
Why it matters
Potential benefit: If successful, this could help identify infants at higher risk for obesity early so caregivers and clinicians can target feeding or monitoring strategies sooner.
How similar studies have gone: Similar metabolic phenotyping approaches have shown informative results in older children and adults, but applying post-meal energy expenditure and respiratory exchange measures to classify infant phenotypes is relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States Recruiting
Study contacts
- Study coordinator: Abby A Altazan, MS
- Email: abby.altazan@pbrc.edu
- Phone: 225-763-2801
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.