Effects of Infant Formula Composition on Infant Feeding Behaviors

NCT00957892 | Completed

• 3 other identifiers: 809649R01HD037119F32HD063343-01A1
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Infants

Keywords

Healthy Infants; Satiation; Satiety; Intake Regulation; Infant Feeding; Infant Formula Feeding

Outcome Measures

Primary Outcomes (2)

• Satiation: volume of formula consumed within a feed

  5-hour period

• Satiety: the duration between feedings

  5-hour period

Secondary Outcomes (3)

• Infant temperature change

  5-hour period

• Infant sleep and activity patterns

  5-hour period

• Maternal perceptions

  5-hour period

Eligibility Criteria

• Age: 1 Month - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Infants who were preterm
• Infants who have medical conditions that interfere with feeding or eating
• No major complications during pregnancy or at birth

Sponsors & Collaborators

• Monell Chemical Senses Center: lead
• Ajinomoto USA, INC.: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 8960567 BACKGROUND

• 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.

  PMID: 22357724 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

Study Officials

• Julie A Mennella, Ph.D.

  Monell Chemical Senses Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Member

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: August 13, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 18, 2017

Record last verified: 2017-12

Locations

US (1)