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Sensitive Periods in Early Flavor Learning

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Julie A. Mennella, Monell Chemical Senses Center
ClinicalTrials.gov Identifier:
NCT00994747
First received: October 12, 2009
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Healthy
Other: Nutramigen (Flavor and Type of Infant Formula)
Other: Enfamil, milk-based formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: Sensitive Periods in Early Flavor Learning

Resource links provided by NLM:


Further study details as provided by Monell Chemical Senses Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • infant growth (weight and length) [ Time Frame: 0.5 to 8.5 months of life ] [ Designated as safety issue: No ]
  • maternal perceptions of infant enjoyment of feeding [ Time Frame: 8.5 months ] [ Designated as safety issue: No ]
  • infants' exploration of toys as a function of scent [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • infants' intake of foods as a function of flavor and chemical composition [ Time Frame: 8 months and 2-3 years ] [ Designated as safety issue: No ]
  • infants' temperament and behavioral development [ Time Frame: 0.5 months -2years ] [ Designated as safety issue: No ]
  • taste receptor and obesity genotypes. [ Time Frame: 8 months and 2-3 years ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: November 2006
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group EEEEEEE
Infant is fed Enfamil from 0.5-7.5 months of life
Other: Enfamil, milk-based formula
Enfamil, milk-based formula, fed as formula source during first 8.5 months of life
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.
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
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
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
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.
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
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.
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
Experimental: Group NNNNNNN
Infant is fed Nutramigen from 0.5-7.5 months of life.
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

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.

  Eligibility

Ages Eligible for Study:   up to 4 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994747

Locations
United States, Pennsylvania
Monell Chemical Senses Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Monell Chemical Senses Center
Investigators
Principal Investigator: Julie A Mennella, PhD Monell Chemical Senses Center
  More Information

Publications:
Responsible Party: Julie A. Mennella, Member, Monell Chemical Senses Center
ClinicalTrials.gov Identifier: NCT00994747     History of Changes
Other Study ID Numbers: 803712
Study First Received: October 12, 2009
Last Updated: October 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Monell Chemical Senses Center:
infancy
nutrition
protein hydrolysate formula
flavor preferences
food preferences
growth
emotional development
mother-infant interaction
infant temperament
feeding patterning
taste receptor and obesity genotype
sensitive period

ClinicalTrials.gov processed this record on November 20, 2014