Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-16
SponsorPennington Biomedical Research Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Meal Test - Human Milk

    Other intervention

    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 intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Energy expenditure difference from baseline to postprandial

Percent difference from baseline to postprandial energy expenditure

Time frame
60 minutes
2

Energy expenditure difference from baseline to postprandial (2)

Absolute difference between baseline and postprandial energy expenditure

Time frame
60 minutes

Secondary outcomes

1

Thrifty and Spendthrift Phenotypes

Number of infants with a thrifty and spendthrift phenotype

Time frame
60 minutes
2

Metabolic flexibility

Difference in respiratory exchange ratio from baseline to postprandial

Time frame
60 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.