Metabolic phenotypes linked to obesity risk in young infants
Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants: A Pilot Study
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 |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 2 Weeks to 16 Weeks |
| Sex | All |
| Sponsor | Pennington Biomedical Research Center Academic / other |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Trial ID | NCT07096011 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Baton Rouge, Louisiana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.