Actively Recruiting

Age: 2Weeks - 16Weeks
All Genders
Healthy Volunteers
ID07096011

Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants: A Pilot Study

Led by Pennington Biomedical Research Center · Updated on 2025-08-22

40

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand how young infants metabolize different meals and to develop clinical tools that identify two metabolic phenotypes: metabolic "thriftiness" and metabolic flexibility. These phenotypes are characterized by differences in energy expenditure and substrate oxidation after consuming meals, which may relate to risks for obesity and other traits. Infant participants will receive two meal tests: one with human milk and one with infant formula. Both meals will be given inside a metabolic chamber where energy expenditure and respiratory exchange ratio will be measured before and after feeding. The amount of food provided will be about 20% of the infant's predicted energy needs, typically 4 to 6 ounces, based on age and sex-specific guidelines. Participants will undergo assessments including energy expenditure and respiratory exchange ratio measurements around 60 minutes after each meal. They will also complete a DXA measurement. The study involves a screening visit and two clinic visits within 14 days. Researchers will analyze changes in energy expenditure and metabolic flexibility to identify the two phenotypes in infants aged 2 to less than 17 weeks.

CONDITIONS

Brief Title

Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants

Who Can Participate

Age: 2Weeks - 16Weeks
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Infant aged 2 weeks to less than 17 weeks at screening
  • Fed human milk as the primary source of food
  • Willing to consume one meal of infant formula
  • Willing to complete a DXA measurement
Not Eligible

You will not qualify if you...

  • Unable to complete the screening visit and two clinic visits within 14 days
  • Born with health conditions that make procedures unsafe
  • Born earlier than 35 weeks gestation
  • Eating supplemental foods besides human milk
  • Physician-diagnosed feeding difficulties requiring a special nipple for bottle feeding

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Observational Meal Tests

Duration - Within 14 days

Participants undergo two meal challenge tests inside a metabolic chamber to measure energy expenditure and metabolic response to human milk and infant formula meals.

2 clinic visits for meal tests

Trial Site Locations

Total: 1 location

1

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808

Actively Recruiting

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Research Team

A

Abby A Altazan, MS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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