An interventional study of Nutramigen (Flavor and Type of Infant Formula) and Enfamil, milk-based formula in Healthy, sponsored by Monell Chemical Senses Center. Completed at 1 site in United States. Open to participants aged 2 Weeks to 4 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-03.
Sponsored by Monell Chemical Senses Center · Not applicable, Interventional, and Basic science
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.
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.
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Exclusion Criteria:
Infant is fed Enfamil from 0.5-7.5 months of life
Other: Enfamil, milk-based formula
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)
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)
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)
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)
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
Enfamil, milk-based formula, fed as formula source during first 8.5 months of life
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
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
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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