Energy Expenditure, Human Milk, Breast Milk, Infant Body Composition and Metabolism, Infant Formula, Metabolic Flexibility, Metabolism
Conditions
Keywords
infant, metabolism, energy expenditure, infant formula, breast milk, human milk, thrifty phenotype, metabolic flexibility
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.
Interventions
OTHERMeal Test - Human Milk
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.
OTHERMeal Test - Infant Formula
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.
Sponsors
Pennington Biomedical Research Center
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 16 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactAbby A Altazan, MS
Outcome results
None listed