Recruiting

Metabolic Phenotypes

Sponsor:

Pennington Biomedical Research Center

Code:

NCT07096011

Conditions

Infant Body Composition and Metabolism

Metabolism

Energy Expenditure

Infant Formula

Human Milk, Breast Milk

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Meal Test - Human Milk

Meal Test - Infant Formula

Study Details

Brief 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.

Conditions

Infant Body Composition and Metabolism

Metabolism

Energy Expenditure

Infant Formula

Human Milk, Breast Milk

Study ID

NCT07096011

Start date

Jul 28, 2025

Status verified date

Aug, 2025

Completion date

May, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Interventions

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 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.

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 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.

Primary outcome measure

  • Energy expenditure difference from baseline to postprandial [ Time Frame: 60 minutes ]
  • Energy expenditure difference from baseline to postprandial (2) [ Time Frame: 60 minutes ]

Central Contacts and Locations

Central contacts

Abby A Altazan, MS

225-763-2801abby.altazan@pbrc.edu

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Emily W Flanagan, PhD

225-763-2828emily.flanagan@pbrc.edu

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

Aug 22, 2025

Last verified

Aug, 2025

Keywords

  • infant
  • metabolism
  • energy expenditure
  • infant formula
  • breast milk
  • human milk
  • thrifty phenotype
  • metabolic flexibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pennington Biomedical Research Center on 2025-08-22.