DevelopmentNCT01667549

Sensitive Periods in Human Flavor Learning

A study testing Timing of Diet and Flavor Experience in people with Development, run by Monell Chemical Senses Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 2 to 3 weeksHealthy volunteers can take part
Conditions the study is for: Development
What is being tested?: Timing of Diet and Flavor Experience
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 97 participants
Where: 1 siteUnited States
Study dates: Aug 2012to 30 Nov 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 3 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Monell Chemical Senses Center
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Read the 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.

Conditions: Development
Being tested: Timing of Diet and Flavor Experience
Keywords: Breastfeeding, Flavor learning, Mother, Moms, Infants, Babies, Baby, Food Habits, Fruits, Vegetables
Medical subject headings: Breast Feeding, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timing of Diet and Flavor ExperienceOther
Groups differ in the timing and duration of exposure to flavored food experience.

Study groups in NCT01667549
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: Other: Timing of Diet and Flavor Experience
Control	No intervention	Mothers will not receive the intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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).
Measured: 6- to 10-month-old weaned infants (3 separate test days)
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).
Measured: Once a month from ages 0.5 - 4.5 months, 10.5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201230 Nov 2015

First posted17 Aug 2012 (estimated)
Study startAug 2012
Primary completionJul 2015
Study completion30 Nov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for DevelopmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01667549
Sponsor's protocol ID: HD37119
Status last verified: Nov 2019
First submitted: 13 Aug 2012
Last updated: 9 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: There is not a plan to make IPD available

Publications

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.
PubMed 11389286
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.
PubMed 12449287
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.
PubMed 21310829
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.
PubMed 15687429
Forestell CA, Mennella JA. Early determinants of fruit and vegetable acceptance. Pediatrics. 2007 Dec;120(6):1247-54. doi: 10.1542/peds.2007-0858.
PubMed 18055673
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.
PubMed 21672566
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.
PubMed 1489209
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.
PubMed 11382663
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.
PubMed 18222499
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.
PubMed 32553836
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.
PubMed 28515063

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sensitive Periods in Human Flavor Learning
ClinicalTrials.gov ID: NCT01667549
Acronym / sponsor ID: HD37119
Conditions: Development
Keywords: Breastfeeding, Flavor learning, Mother, Moms, Infants, Babies, Baby, Food Habits
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: Monell Chemical Senses CenterUniversity, hospital or other
Study start: Aug 2012 (actual)
Primary completion: Jul 2015 (actual)
Study completion: 30 Nov 2015 (actual)
First posted: 17 Aug 2012 (estimated)
Results: Posted 9 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
1M0.5	Experimental	Other: Timing of Diet and Flavor ExperienceMothers will receive the intervention for 1 month beginning when their infant is 0.5 months old. Intervention: Timing of Diet and Flavor Experience
1M1.5	Experimental	Other: Timing of Diet and Flavor ExperienceMothers will receive the intervention for 1 month beginning when their infant is 1.5 months old. Intervention: Timing of Diet and Flavor Experience
3M0.5	Experimental	Other: Timing of Diet and Flavor ExperienceMothers will receive the intervention for 3 months beginning when their infant is 0.5 months old. Intervention: Timing of Diet and Flavor Experience
Control	No intervention	–Mothers will not receive the intervention.

Who may qualify

Ages: 2 to 3 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Timing of Diet and Flavor ExperienceGroups differ in the timing and duration of exposure to flavored food experience.	Other	1M0.5, 1M1.5, 3M0.5

Primary outcome

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).
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).
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) .

2 secondary outcomes

Maternal Perceptions
Time frame: 6- to 10-month-old weaned infants (3 separate test days)
Growth of Infants
Time frame: Once a month from ages 0.5 - 4.5 months, 10.5 months

Results and safety

Results posted to the registry on 9 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1M0.5	20	17
1M1.5	20	15
1M2.5	21	14
3M0.5	20	14
Control	16	15

Primary outcome: Vegetable Flavor Acceptance [Infants' Intake]

Time frame: 6- to 10-month-old weaned infants (3 separate test days ). Mean (Standard Error). Unit: intake in grams

Measure	1M0.5 n = 17	1M1.5 n = 15	1M2.5 n = 14	3M0.5 n = 14	Control n = 15
Intake of plain cereal in grams	56.8 (13.2)	42.4 (12.4)	29.0 (8.5)	40.7 (8.3)	36.5 (6.2)
Intake of carrot cereal in grams	78.2 (14.8)	36.6 (10.0)	57.7 (19.9)	52.2 (9.8)	41.1 (7.6)
Intake of broccoli cereal, grams	41.8 (12.7)	25.5 (8.8)	30.9 (10.1)	34.4 (12.4)	3.04 (6.5)

1M0.5 vs 1M1.5 vs 1M2.5 vs 3M0.5: p = 0.02, planned comparison

Population analysed: Some of the infants refused to eat (plain cereal: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=4; 3M0.5, N=1; carrot cereal: 1M0.5, N=2; 1M1.5, N=2; 1M2.5, N=4; 3M0.5, N=1; Broccoli: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=3; 3M0.5 , N=1) and therefore the number participants analyzed differs from number in each group

Primary outcome: Taste Liking Ratings of Vegetable Flavors [Mothers].

Time frame: Monthly, 0.5 to 4.5 months. Mean (Standard Error). Unit: units on a scale

Measure	1M0.5 n = 17	1M1.5 n = 15	1M2.5 n = 14	3M0.5 n = 14	Control n = 15
Carrot, 0.5 mos (baseline)	-0.07 (4.84)	-3.35 (5.15)	-1.28 (5.33)	-2.02 (5.33)	-4.71 (5.15)
Carrot, 1.5 mos	6.21 (3.41)	1.28 (3.63)	3.91 (3.75)	4.17 (3.75)	1.46 (3.63)
Carrot, 2.5 mos	5.67 (3.19)	3.51 (3.39)	2.08 (3.51)	6.30 (3.51)	-2.53 (3.39)
Carrot, 3.5 mos	3.10 (3.36)	6.20 (3.71)	7.78 (3.7)	3.05 (3.71)	1.56 (3.58)
Carrot, 4.5 mos	5.86 (3.35)	4.82 (3.69)	6.20 (3.69)	2.63 (3.69)	2.75 (3.57)
Beet, 0.5 mos (baseline)	5.81 (5.37)	1.18 (5.72)	-0.65 (5.92)	0.87 (5.92)	-3.21 (5.72)
Beet, 1.5 mos	3.13 (4.16)	9.35 (4.43)	-2.20 (4.58)	3.40 (4.58)	5.73 (4.43)
Beet, 2.5 mos	9.29 (3.50)	6.41 (3.73)	-0.68 (3.86)	1.02 (3.86)	9.17 (3.73)

1M0.5 vs 1M1.5 vs 1M2.5 vs 3M0.5: p <0.02, ANOVA

Population analysed: Two mothers did not complete the ratings on one test date.

Primary outcome: Vegetable Flavor Acceptance (Infants' Rate of Feeding)

Time frame: 6- to 10-month-old weaned infants (3 separate test days). Mean (Standard Error). Unit: grams per minute

Measure	1M0.5 n = 17	1M1.5 n = 15	1M2.5 n = 14	3M0.5 n = 14	Control n = 15
Rate of feeding, plain cereal	6.1 (0.9)	3.9 (1.1)	4.0 (0.8)	4.3 (0.4)	4.9 (0.6)
Rate of feeding, carrot cereal	7.2 (1.1)	3.6 (0.8)	4.8 (1.3)	3.9 (0.5)	3.9 (0.6)
Rate of feeding, broccoli cereal	4.8 (0.8)	2.4 (0.9)	4.5 (1.0)	3.8 (0.9)	4.1 (0.8)

1M0.5 vs 1M1.5 vs 1M2.5 vs 3M0.5: p <0.02, planned comparison

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 15 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1M0.5	0 of 20 (0%)	0 of 20 (0%)	0 of 20
1M1.5	0 of 20 (0%)	0 of 20 (0%)	0 of 20
1M2.5	0 of 21 (0%)	0 of 21 (0%)	0 of 21
3M0.5	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Control	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11389286Mennella 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.
Background: PubMed 12449287Skinner 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.
Background: PubMed 21310829Mennella 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.
Background: PubMed 15687429Mennella 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.
Background: PubMed 18055673Forestell CA, Mennella JA. Early determinants of fruit and vegetable acceptance. Pediatrics. 2007 Dec;120(6):1247-54. doi: 10.1542/peds.2007-0858.
Background: PubMed 21672566Llewellyn 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.
Background: PubMed 1489209Pliner 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.
Background: PubMed 11382663Gerrish 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.
Background: PubMed 18222499Mennella 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.
Derived from this study: PubMed 32553836Mennella 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.
Derived from this study: PubMed 28515063Mennella 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.
Individual participant dataSharing planned: No. There is not a plan to make IPD available

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julie A Mennella, PhD principal investigator

Monell Chemical Senses Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Timing of Diet and Flavor Experience in people with Development, run by Monell Chemical Senses Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vegetable Flavor Acceptance [Infants' Intake] (time frame: 6- to 10-month-old weaned infants (3 separate test days )). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01667549, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.