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NCT Number: NCT07096011

Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants

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.

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Key information

Conditions

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

Age range

2 week–16 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location status: Recruiting

Location contact

Emily W Flanagan, PhD

CONTACT

[email protected]

225-763-2828

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Energy expenditure difference from baseline to postprandial

    Time frame: 60 minutes

    Percent difference from baseline to postprandial energy expenditure

  2. Energy expenditure difference from baseline to postprandial (2)

    Time frame: 60 minutes

    Absolute difference between baseline and postprandial energy expenditure

Secondary outcomes

  1. Thrifty and Spendthrift Phenotypes

    Time frame: 60 minutes

    Number of infants with a thrifty and spendthrift phenotype

  2. Metabolic flexibility

    Time frame: 60 minutes

    Difference in respiratory exchange ratio from baseline to postprandial

Study contacts

Contact information is provided by the study sponsor or research team.

Abby A Altazan, MS

CONTACT

[email protected]

225-763-2801

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

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

Acronym: SPROUT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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