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OpenTrials
Completed

NCT Number: NCT00957892

Effects of Infant Formula Composition on Infant Feeding Behaviors

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.

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Key information

Conditions

Healthy Infants

Age range

1 month–4 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

About this study

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:

  • cow milk based-formula (Enfamil)
  • protein hydrolysate formula (Nutramigen)
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Satiation: volume of formula consumed within a feed

    Time frame: 5-hour period

  2. Satiety: the duration between feedings

    Time frame: 5-hour period

Secondary outcomes

  1. Infant temperature change

    Time frame: 5-hour period

  2. Infant sleep and activity patterns

    Time frame: 5-hour period

  3. Maternal perceptions

    Time frame: 5-hour period

Sponsors and collaborators

Lead sponsor

Monell Chemical Senses Center

Other

Collaborators

  • Ajinomoto USA, INC.
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 13, 2009
Registry last updated
Dec 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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