Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Energy expenditure difference from baseline to postprandial
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Weeks to 16 Weeks (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Energy expenditure difference from baseline to postprandial
Time Frame: 60 minutes
Percent difference from baseline to postprandial energy expenditure
Energy expenditure difference from baseline to postprandial (2)
Time Frame: 60 minutes
Absolute difference between baseline and postprandial energy expenditure
Secondary Outcomes
- Thrifty and Spendthrift Phenotypes(60 minutes)
- Metabolic flexibility(60 minutes)
Investigators
Emily W. Flanagan, MS, PhD
Principal Investigator
Pennington Biomedical Research Center