Text Size

Effects of Infant Formula Composition on Infant Feeding Behaviors

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00957892
First received: August 12, 2009
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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
Healthy Infants

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Effects of Infant Formula Composition on Infant Feeding Behaviors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Monell Chemical Senses Center:

Primary Outcome Measures:
  • Satiation: volume of formula consumed within a feed [ Time Frame: 5-hour period ] [ Designated as safety issue: No ]
  • Satiety: the duration between feedings [ Time Frame: 5-hour period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infant temperature change [ Time Frame: 5-hour period ] [ Designated as safety issue: No ]
  • Infant sleep and activity patterns [ Time Frame: 5-hour period ] [ Designated as safety issue: No ]
  • Maternal perceptions [ Time Frame: 5-hour period ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA collected for analysis of taste receptor and obesity-related genes


Enrollment: 55
Study Start Date: May 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Month to 4 Months
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957892

Locations
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)
Investigators
Principal Investigator: Julie A Mennella, Ph.D. Monell Chemical Senses Center
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Julie A. Mennella, Member, Monell Chemical Senses Center
ClinicalTrials.gov Identifier: NCT00957892     History of Changes
Other Study ID Numbers: 809649, R01HD037119, F32HD063343-01A1
Study First Received: August 12, 2009
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Monell Chemical Senses Center:
Healthy Infants
Satiation
Satiety
 Intake Regulation
Infant Feeding
Infant Formula Feeding

ClinicalTrials.gov processed this record on May 16, 2013