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Clinical Trials/NCT00957892
NCT00957892
Completed
Not Applicable

Effects of Infant Formula Composition on Infant Feeding Behaviors

Monell Chemical Senses Center1 site in 1 country55 target enrollmentMay 2009
ConditionsHealthy Infants

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Infants
Sponsor
Monell Chemical Senses Center
Enrollment
55
Locations
1
Primary Endpoint
Satiation: volume of formula consumed within a feed
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
March 2011
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julie A. Mennella

Member

Monell Chemical Senses Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Satiation: volume of formula consumed within a feed

Time Frame: 5-hour period

Satiety: the duration between feedings

Time Frame: 5-hour period

Secondary Outcomes

  • Maternal perceptions(5-hour period)
  • Infant sleep and activity patterns(5-hour period)
  • Infant temperature change(5-hour period)

Study Sites (1)

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