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Flavor Learning During Infancy

This study is currently recruiting participants.
Verified April 2013 by Monell Chemical Senses Center
Sponsor:
Information provided by (Responsible Party):
Julie A. Mennella, Monell Chemical Senses Center
ClinicalTrials.gov Identifier:
NCT01667549
First received: August 13, 2012
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

The goals of the proposed research are to specify the timing and consequences of the sensitive period for flavor learning in infants who are being breastfed or formula fed. The investigators will conduct a randomized within- and between-subject study of women and their infants during a 15-month window.


Condition Intervention
Focus of the Study is to Determine Whether There Are Sensitive Periods of Flavor Learning in Humans
 Other: Timing of Diet and Flavor Experience

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Sensitive Periods in Human Flavor Learning

Resource links provided by NLM:

MedlinePlus related topics: Breast Feeding
U.S. FDA Resources

Further study details as provided by Monell Chemical Senses Center:

Primary Outcome Measures:
  • Food and flavor acceptance [ Time Frame: Once a month from ages 2 weeks - 15 months ] [ Designated as safety issue: No ]
    Pyschophysical testing conducted on dyad to determine sensitivity and preference for a variety of food flavors.

  • Growth [ Time Frame: Once a month from ages 2 weeks - 15 months ] [ Designated as safety issue: No ]
    Infants and mothers will be weighed and measured and stool and urine samples will be collected for later analysis of biomarkers of growth.


Secondary Outcome Measures:
  • Maternal perception [ Time Frame: Once a month from ages 2 weeks - 15 months ] [ Designated as safety issue: No ]
    Mothers will complete a variety of standardized questionnaires to assess infant temperament, growth and behavior.

  • Genotype [ Time Frame: Once a month from ages 2 weeks - 15 months ] [ Designated as safety issue: No ]
    Saliva will be collected for subsequent determination of obesity- and taste-related genes


Estimated Enrollment: 240
Study Start Date: August 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1M0.5

Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old.

Intervention: Timing of Diet and Flavor Experience

 Other: Timing of Diet and Flavor Experience
Groups differ in the timing and duration of exposure to flavored food experience.
Experimental: 1M1.5

Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old.

Intervention: Timing of Diet and Flavor Experience

 Other: Timing of Diet and Flavor Experience
Groups differ in the timing and duration of exposure to flavored food experience.
Experimental: 3M0.5

Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old.

Intervention: Timing of Diet and Flavor Experience

 Other: Timing of Diet and Flavor Experience
Groups differ in the timing and duration of exposure to flavored food experience.
No Intervention: Control
Mothers will not receive the intervention.

Detailed Description:

This is a randomized clinical trial on both breastfeeding and formula feeding infants to determine the effects of the timing of flavor experiences on subsequent food acceptance in both members of the dyad.

  Eligibility

Ages Eligible for Study:   up to 3 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, term infants and their mothers
  • Infants 2 wks (+/- 2 wk of age)
  • Mothers and infants exclusively breastfeeding or exclusively feeding a cows-milk based formula
  • Mothers must be older than 18 years of age

Exclusion Criteria:

  • Infants who were preterm or have medical conditions that interfere with feeding or eating
  • Mothers who had gestational diabetes or are diagnosed with a major illness requiring treatment or surgery
  • Mothers who will be going back to work full-time before the infant is 4 months old
  • Mothers who are allergic to any vegetables
  • Subjects will not be excluded because of economic status, gender, race or ethnicity.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667549

Contacts
Contact: Julie A Mennella, PhD 267-519-4880 mennella@monell.org
Contact: Ashley R Chambers, MS 267-519-4884 achambers@monell.org

Locations
United States, Pennsylvania
Monell Chemical Senses Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ashley R Chambers, MS     267-519-4884     achambers@monell.org    
Contact: Julie A Mennella, PhD     267-519-4880     mennella@monell.org    
Principal Investigator: Julie A Mennella, PhD            
Sub-Investigator: Ashley R Chambers, MS            
Sub-Investigator: Loran Pryor, MS            
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, Principle Investigator, Monell Chemical Senses Center
ClinicalTrials.gov Identifier: NCT01667549     History of Changes
Other Study ID Numbers: HD37119
Study First Received: August 13, 2012
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Monell Chemical Senses Center:
Breastfeeding
Flavor learning
Mother
Moms
Infants
 Babies
Baby
Food Habits
Fruits
Vegetables

ClinicalTrials.gov processed this record on May 21, 2013