NCT01667549

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2015

Completed
4 years until next milestone

Results Posted

Study results publicly available

December 9, 2019

Completed
Last Updated

December 9, 2019

Status Verified

November 1, 2019

Enrollment Period

2.9 years

First QC Date

August 13, 2012

Results QC Date

January 17, 2019

Last Update Submit

November 20, 2019

Conditions

Keywords

BreastfeedingFlavor learningMotherMomsInfantsBabiesBabyFood HabitsFruitsVegetables

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Maternal Perceptions

    6- to 10-month-old weaned infants (3 separate test days)

  • Growth of Infants

    Once a month from ages 0.5 - 4.5 months, 10.5 months

Study Arms (4)

1M0.5

EXPERIMENTAL

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

1M1.5

EXPERIMENTAL

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

3M0.5

EXPERIMENTAL

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

Control

NO INTERVENTION

Mothers will not receive the intervention.

Interventions

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

1M0.51M1.53M0.5

Eligibility Criteria

Age2 Weeks - 3 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (11)

  • 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.

    PMID: 11389286BACKGROUND
  • 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.

    PMID: 12449287BACKGROUND
  • 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.

    PMID: 21310829BACKGROUND
  • 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.

    PMID: 15687429BACKGROUND
  • Forestell CA, Mennella JA. Early determinants of fruit and vegetable acceptance. Pediatrics. 2007 Dec;120(6):1247-54. doi: 10.1542/peds.2007-0858.

    PMID: 18055673BACKGROUND
  • 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.

    PMID: 21672566BACKGROUND
  • 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.

    PMID: 1489209BACKGROUND
  • 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.

    PMID: 11382663BACKGROUND
  • 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.

    PMID: 18222499BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Breast FeedingFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorBehavior, Animal

Results Point of Contact

Title
Julia A. Mennella, PhD; Study Principal Investigator
Organization
Monell Chemical Senses Center

Study Officials

  • Julie A Mennella, PhD

    Monell Chemical Senses Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Member and Director Emeritus

Study Record Dates

First Submitted

August 13, 2012

First Posted

August 17, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2015

Study Completion

November 30, 2015

Last Updated

December 9, 2019

Results First Posted

December 9, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available

Locations