Effect of Infant Formula on Energy Balance

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.

Official Title
-----------------
Impact of Diet Composition on Energy Balance and Satiety During Infancy

Conditions
-----------------
Development

Intervention / Treatment
-----------------
* Other: Type of Formula


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Week
Maximum Age: 3 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Between- and within-subject longitudinal trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Type of Formula: CMF<br>Infants are randomized to feed standard cow milk formula during first year of life | Other: Type of Formula<br>* infant formula<br>* Other names: protein hydrolysate formula (EHF);|
| Experimental: Type of Formula: EHF<br>Infants are randomized to feed extensively hydrolyzed infant formula during first year of life | Other: Type of Formula<br>* infant formula<br>* Other names: protein hydrolysate formula (EHF);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth, Weight for Length (WLZ) Z Scores | 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). | 0.5 to 12.5 months with followup visit at 18.5 mos | 
| Growth, Weight for Age (WAZ) Z Score | 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). | 0.5 to 12.5 months with followup visit at 18.5 mos | 
| Growth: Length for Age (LAZ) Z Scores | 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). | 0.5 to 12.5 months with followup visit at 18.5 mos | 
| Energy Balance: Energy Intake From Infant Formula and Other Sources | 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 | 0.75, 3.5, 12.5 mos | 
| Energy Balance: Sleeping Energy Expenditure (SEE) | 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. | 0.75, 3.5, 12.5 mos | 
| Energy Balance: Total Energy Expenditure (TEE) | 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 | 0.75, 3.5, 12.5 mos | 
| Energy Balance: Energy Loss in Stools | Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint | 0.75, 3.5, 12.5 mos | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding Behaviors, Maternal Perceptions | Maternal perception of infant feeding behavior, using standardized questionnaires (Infant feeding style questionnaire; IFSQ); values ranged from 1 to 5; higher scores reflect more of that feeding style. Only baseline data reported herein. | 0.5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mother, Infants, Formula Feeding, Moms, Babies, Baby, growth, energy balance