Effect of Infant Formula on Energy Balance

Not Applicable

Completed

• Conditions: Development
• Interventions: Other: Type of Formula

• Registration Number: NCT01700205
• Lead Sponsor: Monell Chemical Senses Center

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 Timeline

• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-04
• Study Start: 2012-11-02
• Primary Completion: 2016-03-17
• Study Completion: 2016-09-21
• Results First Submitted: 2019-03-18
• Results First Submitted QC: 2019-08-13
• Results First Posted: 2019-09-16
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-20
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Type of Formula: CMF	Type of Formula	Infants are randomized to feed standard cow milk formula during first year of life
Type of Formula: EHF	Type of Formula	Infants are randomized to feed extensively hydrolyzed infant formula during first year of life

Primary Outcome Measures

Name	Time	Method
Growth, Weight for Age (WAZ) Z Score	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	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	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	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	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)	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)	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 Outcome Measures

Name	Time	Method
Feeding Behaviors, Maternal Perceptions	0.5 months	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.

Trial Locations

Locations (1)

Monell Chemical Senses Center; 🇺🇸 Philadelphia, Pennsylvania, United States