Effects of Infant Formula Composition on Infant Feeding Behaviors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00957892
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : December 18, 2017
Ajinomoto USA, INC.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Julie A. Mennella, 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.

Condition or disease
Healthy Infants

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 Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Effects of Infant Formula Composition on Infant Feeding Behaviors
Study Start Date : May 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
DNA collected for analysis of taste receptor and obesity-related genes

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Mothers with healthy infants who are between the ages of 1 to 4 months and are exclusively feeding cows milk-based formulas will be recruited from the Philadelphia area for this within-subject experimental research study.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00957892

United States, Pennsylvania
Monell Chemical Senses Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Monell Chemical Senses Center
Ajinomoto USA, INC.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Julie A Mennella, Ph.D. Monell Chemical Senses Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Julie A. Mennella, Member, Monell Chemical Senses Center Identifier: NCT00957892     History of Changes
Other Study ID Numbers: 809649
R01HD037119 ( U.S. NIH Grant/Contract )
F32HD063343-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Keywords provided by Julie A. Mennella, Monell Chemical Senses Center:
Healthy Infants
Intake Regulation
Infant Feeding
Infant Formula Feeding