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Effects of Infant Formula Composition on Infant Feeding Behaviors

NCT ID: NCT00957892

Last Updated: 2017-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Healthy Infants

Keywords

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Healthy Infants Satiation Satiety Intake Regulation Infant Feeding Infant Formula Feeding

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ajinomoto USA, INC.

INDUSTRY

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Monell Chemical Senses Center

OTHER

Sponsor Role lead

Responsible Party

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Julie A. Mennella

Member

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie A Mennella, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Monell Chemical Senses Center

Locations

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Monell Chemical Senses Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Mennella JA, Beauchamp GK. Developmental changes in the acceptance of protein hydrolysate formula. J Dev Behav Pediatr. 1996 Dec;17(6):386-91. doi: 10.1097/00004703-199612000-00003.

Reference Type BACKGROUND
PMID: 8960567 (View on PubMed)

Ventura AK, Beauchamp GK, Mennella JA. Infant regulation of intake: the effect of free glutamate content in infant formulas. Am J Clin Nutr. 2012 Apr;95(4):875-81. doi: 10.3945/ajcn.111.024919. Epub 2012 Feb 22.

Reference Type DERIVED
PMID: 22357724 (View on PubMed)

Other Identifiers

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R01HD037119

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F32HD063343-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

809649

Identifier Type: -

Identifier Source: org_study_id