Effects of Infant Formula Composition on Infant Feeding Behaviors

Healthy Infants Clinical Trial

Official title:

Effects of Infant Formula Composition on Infant Feeding Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957892
• Other study ID #: 809649
• Secondary ID: R01HD037119F32HD
• Status: Completed
• Phase: N/A
• First received: August 12, 2009
• Last updated: December 14, 2017
• Start date: May 2009
• Est. completion date: March 2011

Study information

• Verified date: December 2017
• Source: Monell Chemical Senses Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Healthy Infants

Locations

Country	Name	City	State
United States	Monell Chemical Senses Center	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Monell Chemical Senses Center	Ajinomoto USA, INC., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mennella JA, Beauchamp GK. Developmental changes in the acceptance of protein hydrolysate formula. J Dev Behav Pediatr. 1996 Dec;17(6):386-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satiation: volume of formula consumed within a feed		5-hour period
Primary	Satiety: the duration between feedings		5-hour period
Secondary	Infant temperature change		5-hour period
Secondary	Infant sleep and activity patterns		5-hour period
Secondary	Maternal perceptions		5-hour period