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Sensitive Periods in Human Flavor Learning

Primary Purpose

Development

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Timing of Diet and Flavor Experience
Sponsored by
Monell Chemical Senses Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Development focused on measuring Breastfeeding, Flavor learning, Mother, Moms, Infants, Babies, Baby, Food Habits, Fruits, Vegetables

Eligibility Criteria

2 Weeks - 3 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Monell Chemical Senses Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

1M0.5

1M1.5

3M0.5

Control

Arm Description

Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old. Intervention: 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

Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old. Intervention: Timing of Diet and Flavor Experience

Mothers will not receive the intervention.

Outcomes

Primary Outcome Measures

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).
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).
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) .

Secondary Outcome Measures

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).
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).

Full Information

First Posted
August 13, 2012
Last Updated
November 20, 2019
Sponsor
Monell Chemical Senses Center
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1. Study Identification

Unique Protocol Identification Number
NCT01667549
Brief Title
Sensitive Periods in Human Flavor Learning
Official Title
Sensitive Periods in Human Flavor Learning
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
November 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Monell Chemical Senses Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Development
Keywords
Breastfeeding, Flavor learning, Mother, Moms, Infants, Babies, Baby, Food Habits, Fruits, Vegetables

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1M0.5
Arm Type
Experimental
Arm Description
Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old. Intervention: Timing of Diet and Flavor Experience
Arm Title
1M1.5
Arm Type
Experimental
Arm Description
Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old. Intervention: Timing of Diet and Flavor Experience
Arm Title
3M0.5
Arm Type
Experimental
Arm Description
Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old. Intervention: Timing of Diet and Flavor Experience
Arm Title
Control
Arm Type
No Intervention
Arm Description
Mothers will not receive the intervention.
Intervention Type
Other
Intervention Name(s)
Timing of Diet and Flavor Experience
Intervention Description
Groups differ in the timing and duration of exposure to flavored food experience.
Primary Outcome Measure Information:
Title
Vegetable Flavor Acceptance [Infants' Intake]
Description
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).
Time Frame
6- to 10-month-old weaned infants (3 separate test days )
Title
Taste Liking Ratings of Vegetable Flavors [Mothers].
Description
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).
Time Frame
Monthly, 0.5 to 4.5 months
Title
Vegetable Flavor Acceptance (Infants' Rate of Feeding)
Description
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) .
Time Frame
6- to 10-month-old weaned infants (3 separate test days)
Secondary Outcome Measure Information:
Title
Maternal Perceptions
Description
Mothers rated infants' enjoyment of the taste of the cereal (9-point scale); aratings range from 1 (extreme dislike) to 9 (extreme like).
Time Frame
6- to 10-month-old weaned infants (3 separate test days)
Title
Growth of Infants
Description
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).
Time Frame
Once a month from ages 0.5 - 4.5 months, 10.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
3 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie A Mennella, PhD
Organizational Affiliation
Monell Chemical Senses Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monell Chemical Senses Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available
Citations:
PubMed Identifier
11389286
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.
Results Reference
background
PubMed Identifier
12449287
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.
Results Reference
background
PubMed Identifier
21310829
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.
Results Reference
background
PubMed Identifier
15687429
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.
Results Reference
background
PubMed Identifier
18055673
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.
Results Reference
background
PubMed Identifier
21672566
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.
Results Reference
background
PubMed Identifier
1489209
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.
Results Reference
background
PubMed Identifier
11382663
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.
Results Reference
background
PubMed Identifier
18222499
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.
Results Reference
background
PubMed Identifier
32553836
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.
Results Reference
derived
PubMed Identifier
28515063
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.
Results Reference
derived

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Sensitive Periods in Human Flavor Learning

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