Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants

Recruiting

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

• Registration Number: NCT07096011
• Lead Sponsor: Pennington Biomedical Research Center

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.

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study Start: 2025-07-28
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Primary Completion: 2027-04
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Energy expenditure difference from baseline to postprandial	60 minutes	Percent difference from baseline to postprandial energy expenditure
Energy expenditure difference from baseline to postprandial (2)	60 minutes	Absolute difference between baseline and postprandial energy expenditure

Secondary Outcome Measures

Name	Time	Method
Thrifty and Spendthrift Phenotypes	60 minutes	Number of infants with a thrifty and spendthrift phenotype
Metabolic flexibility	60 minutes	Difference in respiratory exchange ratio from baseline to postprandial

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States