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Sensitive Periods in Human Flavor Learning

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ClinicalTrials.gov Identifier: NCT01667549
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Julie A. Mennella, Monell Chemical Senses Center

Brief Summary:
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 or disease Intervention/treatment Phase
Development Other: Timing of Diet and Flavor Experience Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Sensitive Periods in Human Flavor Learning
Actual Study Start Date : August 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : November 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Food and flavor acceptance [ Time Frame: Once a month from ages 2 weeks - 15 months ]
    Psychophysical testing conducted on dyad to determine sensitivity and preference for a variety of food flavors.

  2. Growth [ Time Frame: Once a month from ages 2 weeks - 15 months ]
    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 :
  1. Maternal perception [ Time Frame: Once a month from ages 2 weeks - 15 months ]
    Mothers will complete a variety of standardized questionnaires to assess infant temperament, growth and behavior.

  2. Genotype [ Time Frame: Once a month from ages 2 weeks - 15 months ]
    Saliva will be collected for subsequent determination of obesity- and taste-related genes



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Ages Eligible for Study:   up to 3 Weeks   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667549


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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Julie A. Mennella, Member and Director Emeritus, Monell Chemical Senses Center
ClinicalTrials.gov Identifier: NCT01667549     History of Changes
Other Study ID Numbers: HD37119
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available

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