Sensitive Periods in Human Flavor Learning

Not Applicable

Completed

• Conditions: Development
• Interventions: Other: Timing of Diet and Flavor Experience

• Registration Number: NCT01667549
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-17
• Primary Completion: 2015-07
• Study Completion: 2015-11-30
• Results First Submitted: 2019-01-17
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-20
• Last Update Submitted: 2019-11-20
• Results First Posted: 2019-12-09
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1M1.5	Timing of Diet and Flavor Experience	Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old. Intervention: Timing of Diet and Flavor Experience
3M0.5	Timing of Diet and Flavor Experience	Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old. Intervention: Timing of Diet and Flavor Experience
1M0.5	Timing of Diet and Flavor Experience	Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old. Intervention: Timing of Diet and Flavor Experience

Primary Outcome Measures

Name	Time	Method
Vegetable Flavor Acceptance [Infants' Intake]	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).
Taste Liking Ratings of Vegetable Flavors [Mothers].	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).
Vegetable Flavor Acceptance (Infants' Rate of Feeding)	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) .

Secondary Outcome Measures

Name	Time	Method
Maternal Perceptions	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).
Growth of Infants	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).

Trial Locations

Locations (1)

Monell Chemical Senses Center; 🇺🇸 Philadelphia, Pennsylvania, United States