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Completed

NCT Number: NCT00994747

Sensitive Periods in Early Flavor Learning

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.

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Key information

Age range

2 week–4 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutramigen (Flavor and Type of Infant Formula)

Other

Nutramigen, protein hydrolysate formula, fed to infants as sole formula source during specified times during the first 8.5 months of life

Enfamil, milk-based formula

Other

Enfamil, milk-based formula, fed as formula source during first 8.5 months of life

Primary outcomes

  1. 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

Secondary outcomes

  1. infant growth (weight and length)

    Time frame: 0.5 to 8.5 months of life

  2. maternal perceptions of infant enjoyment of feeding

    Time frame: 8.5 months

  3. infants' exploration of toys as a function of scent

    Time frame: 9 months

  4. infants' intake of foods as a function of flavor and chemical composition

    Time frame: 8 months and 2-3 years

  5. infants' temperament and behavioral development

    Time frame: 0.5 months -2years

  6. taste receptor and obesity genotypes.

    Time frame: 8 months and 2-3 years

Sponsors and collaborators

Lead sponsor

Monell Chemical Senses Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 14, 2009
Registry last updated
Oct 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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