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Recruiting NCT07096011

Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants

— Observational Infant Body Composition and Metabolism Metabolism Energy Expenditure Infant Formula

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Meal Test - Human Milk, Meal Test - Infant Formula.
Who it may be relevant to
Registry conditions: Infant Body Composition and Metabolism, Metabolism, Energy Expenditure, Infant Formula. Basic parameters: 2 Weeks — 16 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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. This will be accomplished by providing two meal test stimuli to infant participants (human milk and infant formula). Energy expenditure and respiratory exchange ratio will be obtained before and after the meals to calculate the delta in both. From there, two phenotypes will be identified. The first phenotypes is metabolic "thriftiness", which will be defined by the energy expenditure after consuming two standard meals. The second phenotype is the degree of metabolic flexibility and will be defined by substrate oxidation (using respiratory exchange ratio) following two standard meals.

Interventions

  • Other Meal 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 equ
  • Other Meal 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 est

Primary outcome measures

  • Energy expenditure difference from baseline to postprandial [Time frame: 60 minutes]
  • Energy expenditure difference from baseline to postprandial (2) [Time frame: 60 minutes]
Secondary outcome measures (2)
  • Thrifty and Spendthrift Phenotypes [Time frame: 60 minutes]
  • Metabolic flexibility [Time frame: 60 minutes]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

United States · 1 center
  • Pennington Biomedical Research Center — Baton Rouge

Identifiers

NCT: NCT07096011 · 2025-026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗