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Sensitive Periods in Early Flavor Learning

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ClinicalTrials.gov Identifier: NCT00994747
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : October 3, 2012
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Julie A. Mennella, Monell Chemical Senses Center

Tracking Information
First Submitted Date  ICMJE October 12, 2009
First Posted Date  ICMJE October 14, 2009
Last Update Posted Date October 3, 2012
Study Start Date  ICMJE November 2006
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2009)
infants' intake, length of feeding and patterning of feeding of Nutramigen relative to Enfamil (infant-led feeding condition) [ Time Frame: 0.5-8.5 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00994747 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2009)
  • infant growth (weight and length) [ Time Frame: 0.5 to 8.5 months of life ]
  • maternal perceptions of infant enjoyment of feeding [ Time Frame: 8.5 months ]
  • infants' exploration of toys as a function of scent [ Time Frame: 9 months ]
  • infants' intake of foods as a function of flavor and chemical composition [ Time Frame: 8 months and 2-3 years ]
  • infants' temperament and behavioral development [ Time Frame: 0.5 months -2years ]
  • taste receptor and obesity genotypes. [ Time Frame: 8 months and 2-3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sensitive Periods in Early Flavor Learning
Official Title  ICMJE Sensitive Periods in Early Flavor Learning
Brief Summary

Flavor is the primary dimension by which young children determine food acceptance. However, children are not merely miniature adults since sensory systems mature postnatally and their responses to certain tastes differ markedly from adults. Moreover, emerging research has revealed that there are sensitive periods during infancy such that early flavor experiences serve to modify later responses to flavors and foods. The proposed study aims to investigate this important issue by using as a model system a class of infant formulas which are hydrolyzed protein based and thus have very pronounced and distinctive flavors which are unpalatable to older-aged infants and adults. This research was initiated because of anecdotal reports by pediatricians that although it is easy to introduce this type of formula to infants during the first months of life, it becomes extremely difficult to do so later in infancy. Indeed, recent studies in the investigators' laboratory provided the first experimental demonstration that infants younger than 4 months of age willingly accept substantial amounts of, and satiate while feeding, a novel, protein hydrolysate formula. In marked contrast, infants older than 4 months reject the protein hydrolysate formula and this rejection occurs within the first minute of a feed, a finding that strongly suggests the sensory qualities of the formula are responsible, at least in part, for this rejection. Moreover, this rejection is not evident when the investigators test older-aged infants with other unfamiliar, but non-hydrolysate, formulas. In other words, the rejection appears to be in response to a particular component or components of protein hydrolysate formulas. This shift in acceptability can be ameliorated by prior exposure. That is, if these formulas are introduced to infants within the first few months of life and are fed continuously, they remain highly acceptable throughout infancy and early childhood. These observations implicate a sensitive period during development, occurring somewhere before 4 months of age, during which exposure to a formula, which is unpalatable to adults and infants over 4 months of age without exposure, renders it acceptable and presumably palatable. To the investigators' knowledge, this is the clearest example of a sensitive period in the development of responses to foods and flavors in humans thus far identified.

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 primary objective of this longitudinal study is to determine the period during early infancy when exposure to the casein-hydrolysate formula, Nutramigen, renders it acceptable during later infancy. The study also aims to determine how early sensory experiences with formula impact upon food acceptance during infancy (8-9 months of age) and childhood. The investigators will also explore how variation in the genes that encode for taste receptors influence preferences for foods and other behaviors.

Detailed Description

This is a basic research, longitudinal and experimental study in which infants will be randomized into one of six groups (N=10-15 per group) differing in the timing and type of formula that the infant will be fed during each month of the 7-month exposure period. Each mother-infant dyad will be studied from the 2-3rd week of life until approximately 9 months of age. When the infant is less than three weeks of age and the mother's decision to formula feed is well established, infants will be randomized into one of six groups differing in the timing and type of formula that the infant will be fed during each month of the 7-month exposure period. One group (Control EEEEEEE) will be assigned to a milk-based formula, Enfamil (E), whereas another group (NNNNNNN) will be assigned to Nutramigen (N) during the entire 7-month period of this study. The other 4 groups will be assigned to feed Nutramigen for specified periods during their first seven months of life (Groups ENEEEEE, EEENEEE, ENNNEEE).

A variety of methodologies developed in our laboratory will be employed to capture the infants' responses to a particular flavor or taste after the exposure period. That is, at the end of the exposure period, infants will be videotaped while they are 1) feeding formulas; 2) feeding foods (e.g., cereal; soups) that differ in flavors; and 3) exploring scented toys. Each month, infants will be weighed and measured for length as well as evaluated for cognitive and motor development and mothers will completed standardized questionnaires regarding infant temperament. A cheek swab from the mothers and infants will be obtained and genotyped for taste receptor and taste- and obesity- related genes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Other: Nutramigen (Flavor and Type of Infant Formula)
    Nutramigen, protein hydrolysate formula, fed to infants as sole formula source during specified times during the first 8.5 months of life
  • Other: Enfamil, milk-based formula
    Enfamil, milk-based formula, fed as formula source during first 8.5 months of life
Study Arms  ICMJE
  • Active Comparator: Group EEEEEEE
    Infant is fed Enfamil from 0.5-7.5 months of life
    Intervention: Other: Enfamil, milk-based formula
  • Experimental: Group ENEEEEE
    Infant is fed Enfamil during 0.5-1.5 months of life, Nutramigen from 1.5-2.5 months of life and then Enfamil 2.5-7.5 of life.
    Intervention: Other: Nutramigen (Flavor and Type of Infant Formula)
  • Experimental: Group EENEEEE
    Infant is fed Enfamil 0.5-2.5 months of life, Nutramigen from 2.5-3.5 months of life and then Enfamil from 3.5 to 7.5 months of life
    Intervention: Other: Nutramigen (Flavor and Type of Infant Formula)
  • Experimental: Group EEENEEE
    Infant is fed Enfamil from 0.5-3.5 months of life, Nutramigen from 3.5-4.5 months of life and then Enfamil from 4.5-7.5 months of life.
    Intervention: Other: Nutramigen (Flavor and Type of Infant Formula)
  • Experimental: Group ENNNEEE
    Infant if fed Enfamil from month 0.5-1.5 months of life, Nutramigen from 1.5 to 3.5 months of life and then Enfamil again 3.5-7.5 months of life.
    Intervention: Other: Nutramigen (Flavor and Type of Infant Formula)
  • Experimental: Group NNNNNNN
    Infant is fed Nutramigen from 0.5-7.5 months of life.
    Intervention: Other: Nutramigen (Flavor and Type of Infant Formula)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2012)
79
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2009)
90
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy, term infants of any racial background
  • Infants may be of either sex
  • Infants must be 2 weeks 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 4 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00994747
Other Study ID Numbers  ICMJE 803712
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julie A. Mennella, Monell Chemical Senses Center
Study Sponsor  ICMJE Monell Chemical Senses Center
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Julie A Mennella, PhD Monell Chemical Senses Center
PRS Account Monell Chemical Senses Center
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP