Impact of Diet Composition on Energy Balance and Satiety During Infancy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Development
- Sponsor
- Monell Chemical Senses Center
- Enrollment
- 113
- Locations
- 1
- Primary Endpoint
- Growth, Weight for Age (WAZ) Z Score
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The overarching goal of the research we propose here is to conduct a randomized clinical trial to specify the physiologic and behavioral mechanisms by which infant-formula composition affects all aspects of energy balance and growth during the first years of life.
Detailed Description
This is a randomized clinical trial of infants whose parents decided to formula feed them; mother-infant dyads will be randomized when infant is 2 weeks of age to one of 2 groups. The groups will differ in the composition of the formula fed to the infant during the first year of life.
Investigators
Julie A. Mennella, PhD
Member
Monell Chemical Senses Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Growth, Weight for Age (WAZ) Z Score
Time Frame: 0.5 to 12.5 months with followup visit at 18.5 mos
At each visit, infants were weighed to monitor normal growth. These anthropometric data were converted to Weight for age Z (WAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).
Energy Balance: Energy Loss in Stools
Time Frame: 0.75, 3.5, 12.5 mos
Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint
Growth: Length for Age (LAZ) Z Scores
Time Frame: 0.5 to 12.5 months with followup visit at 18.5 mos
At each visit, infants were measured to monitor normal growth. These anthropometric data were converted to Length for age Z (LAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).
Energy Balance: Energy Intake From Infant Formula and Other Sources
Time Frame: 0.75, 3.5, 12.5 mos
Energy intake (kcal/day) of infant formula and other sources was determined by three-day weighed bottle intake and records of the infants' intake of any liquid or food other than formula during the three days
Growth, Weight for Length (WLZ) Z Scores
Time Frame: 0.5 to 12.5 months with followup visit at 18.5 mos
At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length (WLZ) Zscores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).
Energy Balance: Sleeping Energy Expenditure (SEE)
Time Frame: 0.75, 3.5, 12.5 mos
Postprandial SEE (kcal/day), a proxy for resting energy expenditure in infant, was measured for a minimum of 30 min by open-circuit, indirect calorimetry using a metabolic cart with canopy hood, in a quiet, thermal-neutral room.
Energy Balance: Total Energy Expenditure (TEE)
Time Frame: 0.75, 3.5, 12.5 mos
TEE (kcal/day) was measured over 7 days at each of the three time points (0.75, 3.5 and12.5 mos) using the doubly labeled water method
Secondary Outcomes
- Feeding Behaviors, Maternal Perceptions(0.5 months)