Clinical trial NCT01667549: Sensitive Periods in Human Flavor Learning
Official title: Sensitive Periods in Human Flavor Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Development
Keywords: Breastfeeding
Flavor learning
Mother
Moms
Infants
Babies
Baby
Food Habits
Fruits
Vegetables
Lead sponsor: Monell Chemical Senses Center
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 97
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vegetable Flavor Acceptance [Infants' Intake]
timeFrame: 6- to 10-month-old weaned infants (3 separate test days )
measure: Taste Liking Ratings of Vegetable Flavors [Mothers].
timeFrame: Monthly, 0.5 to 4.5 months
measure: Vegetable Flavor Acceptance (Infants' Rate of Feeding)
timeFrame: 6- to 10-month-old weaned infants (3 separate test days)
Secondary outcomes:
measure: Maternal Perceptions
timeFrame: 6- to 10-month-old weaned infants (3 separate test days)
measure: Growth of Infants
timeFrame: Once a month from ages 0.5 - 4.5 months, 10.5 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Monell Chemical Senses Center
state: Pennsylvania
Study officials:
affiliation: Monell Chemical Senses Center
name: Julie A Mennella, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mennella JA, Jagnow CP, Beauchamp GK. Prenatal and postnatal flavor learning by human infants. Pediatrics. 2001 Jun;107(6):E88. doi: 10.1542/peds.107.6.e88.
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. doi: 10.1016/s0002-8223(02)90349-4.
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.
citation: Mennella JA, Pepino MY, Reed DR. Genetic and environmental determinants of bitter perception and sweet preferences. Pediatrics. 2005 Feb;115(2):e216-22. doi: 10.1542/peds.2004-1582.
citation: Forestell CA, Mennella JA. Early determinants of fruit and vegetable acceptance. Pediatrics. 2007 Dec;120(6):1247-54. doi: 10.1542/peds.2007-0858.
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.
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. doi: 10.1016/0195-6663(92)90014-w.
citation: Gerrish CJ, Mennella JA. Flavor variety enhances food acceptance in formula-fed infants. Am J Clin Nutr. 2001 Jun;73(6):1080-5. doi: 10.1093/ajcn/73.6.1080.
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.
citation: Mennella JA, Reiter A, Brewer B, Pohlig RT, Stallings VA, Trabulsi JC. Early Weight Gain Forecasts Accelerated Eruption of Deciduous Teeth and Later Overweight Status during the First Year. J Pediatr. 2020 Oct;225:174-181.e2. doi: 10.1016/j.jpeds.2020.06.019. Epub 2020 Jun 15.
citation: Mennella JA, Daniels LM, Reiter AR. Learning to like vegetables during breastfeeding: a randomized clinical trial of lactating mothers and infants. Am J Clin Nutr. 2017 Jul;106(1):67-76. doi: 10.3945/ajcn.116.143982. Epub 2017 May 17.