Sensitive Periods in Human Flavor Learning

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sensitive Periods in Human Flavor Learning

Conditions
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Development

Intervention / Treatment
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* Other: Timing of Diet and Flavor Experience


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 3 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1M0.5<br>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<br>* Groups differ in the timing and duration of exposure to flavored food experience.<br>|
| Experimental: 1M1.5<br>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<br>* Groups differ in the timing and duration of exposure to flavored food experience.<br>|
| Experimental: 3M0.5<br>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<br>* Groups differ in the timing and duration of exposure to flavored food experience.<br>|
| No Intervention: Control<br>Mothers will not receive the intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vegetable Flavor Acceptance [Infants' Intake] | 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]. | 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) | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, Flavor learning, Mother, Moms, Infants, Babies, Baby, Food Habits, Fruits, Vegetables