Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Pennington Biomedical Research Center
Study ID
NCT07096011
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
2 Weeks - 16 Weeks
Healthy Volunteers
Accepted

Interventions

  • Meal Test - Human Milk — OTHER
    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 — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jul 28, 2025
Status verified
Aug 2025
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
40 participants (estimated)

Primary Outcome Measure

Energy expenditure difference from baseline to postprandial [ Time Frame: 60 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pennington Biomedical Research CenterBaton RougeLouisiana70808
Emily W Flanagan, PhD
[email protected]
225-763-2828

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