Clinical trial Recruiting at 1 site Observational Ages 2 Weeks to 16 Weeks

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 typeObservational
Ages2 Weeks to 16 Weeks
SexAll
Enrollment40 (estimated)
SponsorPennington Biomedical Research Center
Academic / other
Locations1 site (Baton Rouge, Louisiana)
StatusRecruiting
StartedJuly 28, 2025
Main results expectedApril 2027
Study endsMay 2027
Registry record updatedAugust 22, 2025
Trial IDNCT07096011 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.