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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Control | No Intervention | Mothers will not receive the intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timing of Diet and Flavor Experience | Other | Groups differ in the timing and duration of exposure to flavored food experience. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Growth of Infants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie A Mennella, PhD | Monell Chemical Senses Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monell Chemical Senses Center | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11389286 | Background | 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. | |
| 12449287 | Background | 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. |
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There is not a plan to make IPD available
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No mother-infant dyads were excluded from the study prior to assignment to groups.
Pregnant women or newly parturient women who intended to breastfeed their infants exclusively for at least 4 months were recruited from ads in local newspapers, websites, and Philadelphia Women, Infants, and Children (WIC) offices. We enroll mother -infant dyads because both members of the dyads were tested.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1M0.5 | Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old. Intervention: Timing of Diet and Flavor Experience Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience. |
| FG001 | 1M1.5 | Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old. Intervention: Timing of Diet and Flavor Experience Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience. |
| FG002 | 1M2.5 | Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age |
| FG003 | 3M0.5 | Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old. Intervention: Timing of Diet and Flavor Experience Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience. |
| FG004 | Control | Mothers will not receive the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The number of baseline participants refers to number of infants or number of mothers, depending on outcome
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| ID | Title | Description |
|---|---|---|
| BG000 | 1M0.5 | Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old. Intervention: Timing of Diet and Flavor Experience Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience. |
| BG001 | 1M1.5 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Dyads consists of mothers and their infants and different measures were obtained from each. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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 | Posted | Mean | Standard Error | intake in grams | 6- to 10-month-old weaned infants (3 separate test days ) |
|
15 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1M0.5 | Mothers will receive the intervention for 1 month beginning when their infant is 0.5 months old. Intervention: Timing of Diet and Flavor Experience Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia A. Mennella, PhD; Study Principal Investigator | Monell Chemical Senses Center | 267-519-4880 | mennella@monell.org |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001522 | Behavior, Animal |
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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 |
| 21310829 | Background | 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. |
| 15687429 | Background | 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. |
| 18055673 | Background | Forestell CA, Mennella JA. Early determinants of fruit and vegetable acceptance. Pediatrics. 2007 Dec;120(6):1247-54. doi: 10.1542/peds.2007-0858. |
| 21672566 | Background | 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. |
| 1489209 | Background | 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. |
| 11382663 | Background | 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. |
| 18222499 | Background | 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. |
| 32553836 | Derived | 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. |
| 28515063 | Derived | 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. |
Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old. Intervention: Timing of Diet and Flavor Experience Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience. |
| BG002 | 1M2.5 | Mothers will receive the intervention for one month beginning when their infants are 2.5 months old. Intervention: Timing of Diet and Flavor Experience Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience. |
| BG003 | 3M0.5 | Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old. Intervention: Timing of Diet and Flavor Experience Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience. |
| BG004 | Control | Mothers will not receive the intervention. |
| BG005 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Months |
|
| Age, Continuous | Mean | Standard Deviation | Mothers' Age in years |
|
| Sex: Female, Male | The genotype of infants are reported separately from mothers. Genotyping was attempted but failed for one infant. | Infants are reported separately from mothers | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Infants are reported separately from mothers. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Infants are reported separately from mothers. | Count of Participants | Participants |
|
| Genotype, TAS2R38 taste gene [secondary outcome] | Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant. | Count of Participants | Participants |
|
| OG001 | 1M1.5 | Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old. Intervention: Timing of Diet and Flavor Experience Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience. |
| OG002 | 1M2.5 | Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age |
| OG003 | 3M0.5 | Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old. Intervention: Timing of Diet and Flavor Experience Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience. |
| OG004 | Control | Mothers will not receive the intervention. |
|
|
|
| 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). | Two mothers did not complete the ratings on one test date. | Posted | Mean | Standard Error | units on a scale | 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) . | 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. | Posted | Mean | Standard Error | 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). | 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 of maternal ratings analyzed differs from number in each group | Posted | Mean | Standard Error | Score on a scale | 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). | Number of infants who were weighted and measured to determine Weight for Length Z scores (WLZ) during trial; some dyads did not complete the trial so number of participants analyzed does not always match number enrolled. | Posted | Mean | Standard Error | Z score | Once a month from ages 0.5 - 4.5 months, 10.5 months |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 1M1.5 | Mothers will receive the intervention for 1 month beginning when their infant is 1.5 months old. Intervention: Timing of Diet and Flavor Experience Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | 1M2.5 | Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age | 0 | 21 | 0 | 21 | 0 | 21 |
| EG003 | 3M0.5 | Mothers will receive the intervention for 3 months beginning when their infant is 0.5 months old. Intervention: Timing of Diet and Flavor Experience Timing of Diet and Flavor Experience: Groups differ in the timing and duration of exposure to flavored food experience. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG004 | Control | Mothers will not receive the intervention. | 0 | 16 | 0 | 16 | 0 | 16 |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| TAS2R38 genotype AP [taster, heterozygote] |
|
| TAS2R38 genotype PP [taster] |
|
| Genotyping unsuccessful |
|
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|
| Carrot, 1.5 mos |
|
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| Carrot, 2.5 mos |
|
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| Carrot, 3.5 mos |
|
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| Carrot, 4.5 mos |
|
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| Beet, 0.5 mos (baseline) |
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| Beet, 1.5 mos |
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| Beet, 2.5 mos |
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| Beet, 3.5 mos |
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| Beet, 4.5 mos |
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| Mixed Vegetables, 0.5 mos (baseline) |
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| Mixed Vegetables, 1.5 mos |
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| Mixed Vegetables, 2.5 mos |
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| Mixed Vegetables, 3.5 mos |
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| Mixed Vegetables, 4.5 mos |
|
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| Celery, 0.5 mos (baseline) |
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| Celery, 1.5 mos |
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| Celery, 2.5 mos |
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| Celery, 3.5 mos |
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| Celery, 4.5 mos |
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| Apple, 0.5 mos (Baseline) |
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| Apple, 1.5 mos |
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| Apple, 2.5 months |
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| Apple, 3.5 mos |
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| Apple, 4.5 months |
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| Rate of feeding, carrot cereal |
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| Rate of feeding, broccoli cereal |
|
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| Other |
Repeated Measures ANOVA were done with type of cereal as within-subjects and experimental group as grouping factors. When significant, planned comparisons were carried out. ANOVAs with a priori contrasts specified determined whether 1-month exposure differed from the no-exposure control (timing hypothesis). ANOVAs with a priori contrasts specified determined whether 1-month differed from 3-months exposure and whether these groups differed from no-exposure control (duration hypothesis). |
|
| Rating of infant enjoyment, carrot cereal |
|
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| Rating of infant enjoyment, broccoli cere |
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| Other |
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| Weight for Length Z: 1.5 months |
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| Weight for Length Z: 2.5 months |
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| Weight for Length Z: 3.5 months |
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| Weight for Length Z: 4.5 months |
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| Weight for Length Z, 10.5 months |
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