Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants

NCT07096011 | Recruiting

• 1 other identifier: 2025-026
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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; Metabolic Flexibility

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Energy expenditure difference from baseline to postprandial

  Percent difference from baseline to postprandial energy expenditure

  60 minutes

• Energy expenditure difference from baseline to postprandial (2)

  Absolute difference between baseline and postprandial energy expenditure

  60 minutes

Secondary Outcomes (2)

• Thrifty and Spendthrift Phenotypes

  60 minutes

• Metabolic flexibility

  60 minutes

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.

Eligibility Criteria

• Age: 2 Weeks - 16 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Up to 40 infants who are less than 17 weeks will be recruited to participate in this study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

human milk

Central Study Contacts

Abby A Altazan, MS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: July 28, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (1)