Effects of Infant Formula Composition on Infant Feeding Behaviors

Completed

• Conditions: Healthy Infants

• Registration Number: NCT00957892
• Lead Sponsor: Monell Chemical Senses Center

Brief Summary

There is a paucity of information on whether and how the composition of formulas fed to infants influences their short-term feeding behaviors during the first few months of life. The purpose of this study is to investigate whether the composition of infant formula affects infants' feeding behaviors, in particular, how much formula is consumed within a given feed (i.e., measure of satiation) and how much time elapses after the feed until the infant exhibits signs of hunger (i.e., measure of satiety). The investigators will also examine the relationship between the composition of infant formula consumed and infant temperature, activity, sleep, and mothers' perceptions of infants' intake and regulatory behaviors.

Detailed Description

This is a within-subject, 3-day study. Each mother-infant dyad will visit the Monell Center three times, for 5 hours each time. The protocol during the three visits will be identical. Upon arrival, the infant will be changed into a light-weight cotton body suit. Infants and mothers will be weighed and measured for height. An activity sensor will be placed on the infant and temperature sensors will be placed on both the infant and the mother. When the infant signals hunger, he/she will be fed one of three formulas in randomized order:

1. cow milk based-formula (Enfamil)

2. protein hydrolysate formula (Nutramigen)

3. cow milk-based formula with glutamate level similar to Nutramigen (Enfamilg)

Intake will be monitored and all feeds will be videotaped. In between feedings, infants will rest or sleep on their backs in a crib and mothers will fill out questionnaires.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Healthy, term infants of any racial background
• Infants may be of either sex
• Infants must be between 1 and 4 months of age
• Infants must be exclusively feeding a cow's milk-based formula
• Mothers must be over 18 years of age

Exclusion Criteria

• Infants who were preterm
• Infants who have medical conditions that interfere with feeding or eating
• No major complications during pregnancy or at birth

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Satiation: volume of formula consumed within a feed	5-hour period
Satiety: the duration between feedings	5-hour period

Secondary Outcome Measures

Name	Time	Method
Infant sleep and activity patterns	5-hour period
Infant temperature change	5-hour period
Maternal perceptions	5-hour period

Trial Locations

Locations (1)

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