Sensitive Periods in Human Flavor Learning

Development Clinical Trial

Official title:

Sensitive Periods in Human Flavor Learning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667549
• Other study ID #: HD37119
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: November 30, 2015

Study information

• Verified date: November 2019
• Source: Monell Chemical Senses Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: November 30, 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Development
• Hypersensitivity

Intervention

Other:
• Timing of Diet and Flavor Experience
Groups differ in the timing and duration of exposure to flavored food experience.

Locations

Country	Name	City	State
United States	Monell Chemical Senses Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Monell Chemical Senses Center

Country where clinical trial is conducted

United States, 

References & Publications (9)

Forestell CA, Mennella JA. Early determinants of fruit and vegetable acceptance. Pediatrics. 2007 Dec;120(6):1247-54. — View Citation

Gerrish CJ, Mennella JA. Flavor variety enhances food acceptance in formula-fed infants. Am J Clin Nutr. 2001 Jun;73(6):1080-5. — View Citation

Llewellyn CH, van Jaarsveld CH, Johnson L, Carnell S, Wardle J. Development and factor structure of the Baby Eating Behaviour Questionnaire in the Gemini birth cohort. Appetite. 2011 Oct;57(2):388-96. doi: 10.1016/j.appet.2011.05.324. Epub 2011 Jun 6. — View Citation

Mennella JA, Jagnow CP, Beauchamp GK. Prenatal and postnatal flavor learning by human infants. Pediatrics. 2001 Jun;107(6):E88. — View Citation

Mennella JA, Lukasewycz LD, Castor SM, Beauchamp GK. The timing and duration of a sensitive period in human flavor learning: a randomized trial. Am J Clin Nutr. 2011 May;93(5):1019-24. doi: 10.3945/ajcn.110.003541. Epub 2011 Feb 10. — View Citation

Mennella JA, Nicklaus S, Jagolino AL, Yourshaw LM. Variety is the spice of life: strategies for promoting fruit and vegetable acceptance during infancy. Physiol Behav. 2008 Apr 22;94(1):29-38. doi: 10.1016/j.physbeh.2007.11.014. Epub 2007 Nov 21. — View Citation

Mennella JA, Pepino MY, Reed DR. Genetic and environmental determinants of bitter perception and sweet preferences. Pediatrics. 2005 Feb;115(2):e216-22. — View Citation

Pliner P, Hobden K. Development of a scale to measure the trait of food neophobia in humans. Appetite. 1992 Oct;19(2):105-20. — View Citation

Skinner JD, Carruth BR, Wendy B, Ziegler PJ. Children's food preferences: a longitudinal analysis. J Am Diet Assoc. 2002 Nov;102(11):1638-47. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 )
Primary	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
Primary	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	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)
Secondary	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