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HealthyNCT00994747

Sensitive Periods in Early Flavor Learning

A study testing Nutramigen (Flavor and Type of Infant Formula) and Enfamil, milk-based formula in people with Healthy, run by Monell Chemical Senses Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 4 weeksHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Nutramigen (Flavor and Type of Infant Formula) and Enfamil, milk-based formula
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteUnited States
Study dates
Nov 2006to Jun 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 4 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Monell Chemical Senses Center

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Read the 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.

Conditions
Healthy
Being tested
Nutramigen (Flavor and Type of Infant Formula), Enfamil, milk-based formula
Keywords
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
Medical subject headings
Food Preferences

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 formulaOther

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

Study groups in NCT00994747
Study groupRoleWhat they receive
Group EEEEEEEActive comparatorInfant is fed Enfamil from 0.5-7.5 months of life
Receives: Other: Enfamil, milk-based formula
Group ENEEEEEExperimentalInfant 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.
Receives: Other: Nutramigen (Flavor and Type of Infant Formula)
Group EENEEEEExperimentalInfant 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
Receives: Other: Nutramigen (Flavor and Type of Infant Formula)
Group EEENEEEExperimentalInfant 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.
Receives: Other: Nutramigen (Flavor and Type of Infant Formula)
Group ENNNEEEExperimentalInfant 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.
Receives: Other: Nutramigen (Flavor and Type of Infant Formula)
Group NNNNNNNExperimentalInfant is fed Nutramigen from 0.5-7.5 months of life.
Receives: Other: Nutramigen (Flavor and Type of Infant Formula)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. infants' intake, length of feeding and patterning of feeding of Nutramigen relative to Enfamil (infant-led feeding condition)

    Measured: 0.5-8.5 months

Secondary outcomes (6)
  1. infant growth (weight and length)

    Measured: 0.5 to 8.5 months of life

  2. maternal perceptions of infant enjoyment of feeding

    Measured: 8.5 months

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

    Measured: 9 months

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

    Measured: 8 months and 2-3 years

  5. infants' temperament and behavioral development

    Measured: 0.5 months -2years

  6. taste receptor and obesity genotypes.

    Measured: 8 months and 2-3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2009 (estimated)
  2. Study startNov 2006
  3. Primary completionMay 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00994747
Sponsor's protocol ID
803712
Status last verified
Oct 2012
First submitted
12 Oct 2009
Last updated
3 Oct 2012
Results posted
No
Data monitoring committee
No

Publications

  • Mennella JA, Lukasewycz LD, Castor SM, Beauchamp GK. The timing and duration of a sensitive period in human flavor learning: a randomized trial. Am J Clin Nutr. 2011 May;93(5):1019-24. doi: 10.3945/ajcn.110.003541. Epub 2011 Feb 10.

    PubMed 21310829
  • Mennella JA, Ventura AK, Beauchamp GK. Differential growth patterns among healthy infants fed protein hydrolysate or cow-milk formulas. Pediatrics. 2011 Jan;127(1):110-8. doi: 10.1542/peds.2010-1675. Epub 2010 Dec 27.

    PubMed 21187303
  • Mennella JA, Trabulsi JC, Papas MA. Effects of cow milk versus extensive protein hydrolysate formulas on infant cognitive development. Amino Acids. 2016 Mar;48(3):697-705. doi: 10.1007/s00726-015-2118-7. Epub 2015 Oct 26.

    PubMed 26497857

Questions about this trial

What is this clinical trial studying?

A study testing Nutramigen (Flavor and Type of Infant Formula) and Enfamil, milk-based formula in people with Healthy, run by Monell Chemical Senses Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00994747, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2012.

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