Clinical trial

Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants

Recruiting now · Not applicable · 1 countries · Registry ID NCT07096011

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age2 Weeks to 16 Weeks

SexAll

Healthy volunteersAccepted

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

Full registry criteria

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

Treatments and study arms

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

Energy expenditure difference from baseline to postprandial60 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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

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

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Emily W Flanagan, PhDContact

Email · Call 225-763-2828