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Completed

NCT Number: NCT01667549

Sensitive Periods in Human Flavor Learning

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.

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Key information

Conditions

Development Behavior Behavior, Animal Breast Feeding Feeding Behavior

Age range

2 week–3 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Timing of Diet and Flavor Experience

Other

Groups differ in the timing and duration of exposure to flavored food experience.

Primary outcomes

  1. 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).

  2. 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).

  3. 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) .

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Monell Chemical Senses Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 17, 2012
Registry last updated
Dec 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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