RecruitingNCT07096011

Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants

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

Sponsor

Pennington Biomedical Research Center

Enrollment

40 participants

Start Date

Jul 28, 2025

Study Type

OBSERVATIONAL

Conditions

Metabolic Flexibility Metabolism Infant Formula Energy Expenditure Infant Body Composition and Metabolism Human Milk, Breast Milk

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.

Eligibility

Min Age: 2 WeeksMax Age: 16 Weeks

Inclusion Criteria4

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 Criteria5

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

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Interventions

OTHERMeal Test - Human Milk

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.

OTHERMeal Test - Infant Formula

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.