Sensitive Periods in Human Flavor Learning

November 20, 2019 updated by: Julie A. Mennella, PhD, Monell Chemical Senses Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Monell Chemical Senses Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 3 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vegetable Flavor Acceptance [Infants' Intake]
Time Frame: 6- to 10-month-old weaned infants (3 separate test days )
Taste testing conducted on infants to determine acceptance of plain cereal, carrot-flavor cereal (exposed flavor for intervention groups) and broccoli-flavored cereal (novel flavor for all groups) after weaning, which occurred at ~ 8 months of age. Outcomes included intake (in grams).
6- to 10-month-old weaned infants (3 separate test days )
Taste Liking Ratings of Vegetable Flavors [Mothers].
Time Frame: Monthly, 0.5 to 4.5 months
Psychophysical testing conducted on mothers to rate their taste of carrot, beet, celery, mixed vegetable (exposed flavors for intervention groups) and apple juices using the hedonic gLMS (hedonic general labelled magnitude scale). Ratings on the scale range from -100 (strongest imaginable dislike) to 0 (neutral) to 100 (strongest imaginable like).
Monthly, 0.5 to 4.5 months
Vegetable Flavor Acceptance (Infants' Rate of Feeding)
Time Frame: 6- to 10-month-old weaned infants (3 separate test days)
Taste testing conducted on infants to determine acceptance of plain cereal, carrot-flavor cereal (exposed flavor for intervention groups) and broccoli-flavored cereal (novel flavor for all groups) after weaning, which occurred at ~ 8 months of age. Outcomes included intake rate of feeding (grams per minute) .
6- to 10-month-old weaned infants (3 separate test days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Perceptions
Time Frame: 6- to 10-month-old weaned infants (3 separate test days)
Mothers rated infants' enjoyment of the taste of the cereal (9-point scale); aratings range from 1 (extreme dislike) to 9 (extreme like).
6- to 10-month-old weaned infants (3 separate test days)
Growth of Infants
Time Frame: Once a month from ages 0.5 - 4.5 months, 10.5 months
At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length z-scores (WLZ) using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean or median value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).
Once a month from ages 0.5 - 4.5 months, 10.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monell Chemical Senses Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

November 30, 2015

Study Registration Dates

First Submitted

August 13, 2012

First Submitted That Met QC Criteria

August 15, 2012

First Posted (Estimate)

August 17, 2012

Study Record Updates

Last Update Posted (Actual)

December 9, 2019

Last Update Submitted That Met QC Criteria

November 20, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD37119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is not a plan to make IPD available

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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