Impact of Diet Composition on Energy Balance and Satiety During Infancy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 113
- Locations
- 1
- Primary Endpoint
- Growth: Length for Age (LAZ) Z Scores
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Week to 3 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •A healthy, term (≥37 and ≤42 week gestation at birth), singleton infant.
- •Birth weight between 2500 - 4500 grams.
- •At the time of enrollment, infant must be ≤14 days old (Date of birth=day 0).
- •Mother must be 18 years or older.
- •Infant must be consuming a standard cow's milk protein infant formula and have been receiving a standard cow's milk protein infant formula for at least the past 2 days prior to enrollment.
Exclusion Criteria
- •Mother had gestational diabetes during pregnancy
- •Infant has condition requiring infant feedings other than feeding cow milk formula from a bottle.
- •Infant has major congenital malformations (i.e. cleft palate, hemangiomas, extremity malformation).
- •Infant has suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus).
- •Infant has evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases. For example, infant must not be receiving insulin or growth hormone.
- •Dyad be the relative (son, daughter, niece, nephew, cousin, aunt, uncle, sibling) of ancillary personnel connected with the study.
Arms & Interventions
Type of Formula: CMF
Infants are randomized to feed standard cow milk formula during first year of life
Intervention: Type of Formula (Other)
Type of Formula: EHF
Infants are randomized to feed extensively hydrolyzed infant formula during first year of life
Intervention: Type of Formula (Other)
Outcomes
Primary Outcomes
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 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, 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)
Investigators
Julie A. Mennella, PhD
Member
Monell Chemical Senses Center