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Sensitive Periods in Human Flavor Learning

Sensitive Periods in Human Flavor Learning

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01667549
Enrollment
97
Registered
2012-08-17
Start date
2012-08-31
Completion date
2015-11-30
Last updated
2019-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development

Keywords

Breastfeeding, Flavor learning, Mother, Moms, Infants, Babies, Baby, Food Habits, Fruits, Vegetables

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.

Interventions

OTHERTiming of Diet and Flavor Experience

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

Sponsors

Monell Chemical Senses Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
2 Weeks to 3 Weeks
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Vegetable Flavor Acceptance [Infants' Intake]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].Monthly, 0.5 to 4.5 monthsPsychophysical 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)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) .

Secondary

MeasureTime frameDescription
Maternal Perceptions6- to 10-month-old weaned infants (3 separate test days)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 InfantsOnce a month from ages 0.5 - 4.5 months, 10.5 monthsAt 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).

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

No mother-infant dyads were excluded from the study prior to assignment to groups.

Participants by arm

ArmCount
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.
20
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.
20
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.
21
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.
20
Control
Mothers will not receive the intervention.
16
Total97

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Overall StudyWithdrawal by Subject35761

Baseline characteristics

Characteristic1M0.51M1.51M2.53M0.5ControlTotal
Age, Continuous
Infants' Age in months
0.5 Months
STANDARD_DEVIATION 0.1
0.6 Months
STANDARD_DEVIATION 0.1
0.6 Months
STANDARD_DEVIATION 0.1
0.6 Months
STANDARD_DEVIATION 0.1
0.5 Months
STANDARD_DEVIATION 0.1
0.5 Months
STANDARD_DEVIATION 0.1
Age, Continuous32.5 Mothers' Age in years
STANDARD_DEVIATION 4.4
30.5 Mothers' Age in years
STANDARD_DEVIATION 6.2
29.8 Mothers' Age in years
STANDARD_DEVIATION 5.2
29.9 Mothers' Age in years
STANDARD_DEVIATION 5.1
31.7 Mothers' Age in years
STANDARD_DEVIATION 5.9
30.8 Mothers' Age in years
STANDARD_DEVIATION 5.4
Ethnicity (NIH/OMB)
Infants
Hispanic or Latino
2 Participants4 Participants4 Participants3 Participants1 Participants14 Participants
Ethnicity (NIH/OMB)
Infants
Not Hispanic or Latino
18 Participants16 Participants17 Participants17 Participants15 Participants83 Participants
Ethnicity (NIH/OMB)
Infants
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Mothers
Hispanic or Latino
2 Participants3 Participants2 Participants2 Participants0 Participants9 Participants
Ethnicity (NIH/OMB)
Mothers
Not Hispanic or Latino
18 Participants17 Participants19 Participants18 Participants16 Participants88 Participants
Ethnicity (NIH/OMB)
Mothers
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Genotype, TAS2R38 taste gene [secondary outcome]
Infants
Genotyping unsuccessful
0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants
Genotype, TAS2R38 taste gene [secondary outcome]
Infants
TAS2R38 genotype, AA [non taster]
7 Participants6 Participants3 Participants7 Participants8 Participants31 Participants
Genotype, TAS2R38 taste gene [secondary outcome]
Infants
TAS2R38 genotype AP [taster, heterozygote]
12 Participants8 Participants11 Participants7 Participants5 Participants43 Participants
Genotype, TAS2R38 taste gene [secondary outcome]
Infants
TAS2R38 genotype PP [taster]
1 Participants6 Participants7 Participants6 Participants2 Participants22 Participants
Genotype, TAS2R38 taste gene [secondary outcome]
Mothers
Genotyping unsuccessful
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Genotype, TAS2R38 taste gene [secondary outcome]
Mothers
TAS2R38 genotype, AA [non taster]
4 Participants5 Participants5 Participants7 Participants11 Participants32 Participants
Genotype, TAS2R38 taste gene [secondary outcome]
Mothers
TAS2R38 genotype AP [taster, heterozygote]
12 Participants9 Participants9 Participants8 Participants3 Participants41 Participants
Genotype, TAS2R38 taste gene [secondary outcome]
Mothers
TAS2R38 genotype PP [taster]
4 Participants6 Participants7 Participants5 Participants2 Participants24 Participants
Race (NIH/OMB)
Infants
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Infants
Asian
0 Participants1 Participants0 Participants0 Participants1 Participants2 Participants
Race (NIH/OMB)
Infants
Black or African American
3 Participants7 Participants8 Participants8 Participants5 Participants31 Participants
Race (NIH/OMB)
Infants
More than one race
4 Participants3 Participants4 Participants3 Participants1 Participants15 Participants
Race (NIH/OMB)
Infants
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Infants
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Infants
White
13 Participants9 Participants9 Participants9 Participants9 Participants49 Participants
Race (NIH/OMB)
Mothers
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Mothers
Asian
0 Participants1 Participants0 Participants0 Participants1 Participants2 Participants
Race (NIH/OMB)
Mothers
Black or African American
4 Participants7 Participants10 Participants9 Participants5 Participants35 Participants
Race (NIH/OMB)
Mothers
More than one race
2 Participants3 Participants0 Participants1 Participants0 Participants6 Participants
Race (NIH/OMB)
Mothers
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Mothers
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Mothers
White
14 Participants9 Participants11 Participants10 Participants10 Participants54 Participants
Sex: Female, Male
Sex of Infants
Female
10 Participants11 Participants9 Participants13 Participants7 Participants50 Participants
Sex: Female, Male
Sex of Infants
Male
10 Participants9 Participants12 Participants7 Participants9 Participants47 Participants
Sex: Female, Male
Sex of Mothers
Female
20 Participants20 Participants21 Participants20 Participants16 Participants97 Participants
Sex: Female, Male
Sex of Mothers
Male
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 200 / 210 / 200 / 16
other
Total, other adverse events
0 / 200 / 200 / 210 / 200 / 16
serious
Total, serious adverse events
0 / 200 / 200 / 210 / 200 / 16

Outcome results

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).

Time frame: Monthly, 0.5 to 4.5 months

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

ArmMeasureGroupValue (MEAN)Dispersion
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 1.5 mos6.21 units on a scaleStandard Error 3.41
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 1.5 mos9.48 units on a scaleStandard Error 3.96
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 0.5 mos (baseline)1.22 units on a scaleStandard Error 5.05
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 4.5 mos8.63 units on a scaleStandard Error 3.48
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 2.5 mos9.29 units on a scaleStandard Error 3.5
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 3.5 mos13.39 units on a scaleStandard Error 3.52
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 3.5 mos10.87 units on a scaleStandard Error 3.94
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 2.5 months18.09 units on a scaleStandard Error 2.95
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 1.5 mos17.04 units on a scaleStandard Error 2.98
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 3.5 mos3.10 units on a scaleStandard Error 3.36
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 0.5 mos (baseline)-0.07 units on a scaleStandard Error 4.84
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 0.5 mos (Baseline)17.85 units on a scaleStandard Error 3.64
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 4.5 mos-6.15 units on a scaleStandard Error 3.77
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 3.5 mos-5.12 units on a scaleStandard Error 3.72
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 4.5 mos5.86 units on a scaleStandard Error 3.35
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 4.5 months15.89 units on a scaleStandard Error 2.73
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 2.5 mos-0.92 units on a scaleStandard Error 3.99
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 1.5 mos-3.93 units on a scaleStandard Error 3.86
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 0.5 mos (baseline)0.59 units on a scaleStandard Error 4.72
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 0.5 mos (baseline)5.81 units on a scaleStandard Error 5.37
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 2.5 mos5.67 units on a scaleStandard Error 3.19
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 4.5 mos8.40 units on a scaleStandard Error 3.32
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 3.5 mos7.00 units on a scaleStandard Error 3.52
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 2.5 mos10.19 units on a scaleStandard Error 3.31
1M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 1.5 mos3.13 units on a scaleStandard Error 4.16
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 2.5 mos6.41 units on a scaleStandard Error 3.73
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 2.5 mos3.51 units on a scaleStandard Error 3.39
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 3.5 mos6.20 units on a scaleStandard Error 3.71
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 4.5 mos4.82 units on a scaleStandard Error 3.69
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 0.5 mos (baseline)1.18 units on a scaleStandard Error 5.72
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 1.5 mos9.35 units on a scaleStandard Error 4.43
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 1.5 mos1.28 units on a scaleStandard Error 3.63
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 3.5 mos7.74 units on a scaleStandard Error 4.34
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 4.5 mos10.34 units on a scaleStandard Error 3.83
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 0.5 mos (baseline)0.20 units on a scaleStandard Error 5.38
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 1.5 mos0.18 units on a scaleStandard Error 4.22
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 2.5 mos6.32 units on a scaleStandard Error 3.52
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 3.5 mos5.69 units on a scaleStandard Error 3.88
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 4.5 mos6.83 units on a scaleStandard Error 3.66
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 0.5 mos (baseline)-5.33 units on a scaleStandard Error 5.02
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 1.5 mos-0.90 units on a scaleStandard Error 3.92
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 2.5 mos-0.51 units on a scaleStandard Error 4.24
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 3.5 mos1.07 units on a scaleStandard Error 4.1
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 4.5 mos-1.44 units on a scaleStandard Error 4.16
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 0.5 mos (Baseline)17.48 units on a scaleStandard Error 3.88
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 1.5 mos20.08 units on a scaleStandard Error 3.17
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 2.5 months15.97 units on a scaleStandard Error 3.15
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 3.5 mos22.56 units on a scaleStandard Error 3.88
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 4.5 months19.87 units on a scaleStandard Error 3.01
1M1.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 0.5 mos (baseline)-3.35 units on a scaleStandard Error 5.15
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 1.5 mos3.91 units on a scaleStandard Error 3.75
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 1.5 mos-13.48 units on a scaleStandard Error 4.06
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 1.5 mos-2.20 units on a scaleStandard Error 4.58
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 0.5 mos (Baseline)22.41 units on a scaleStandard Error 4.02
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 4.5 mos6.20 units on a scaleStandard Error 3.69
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 4.5 months15.45 units on a scaleStandard Error 3.01
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 2.5 mos-3.01 units on a scaleStandard Error 4.39
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 0.5 mos (baseline)0.82 units on a scaleStandard Error 5.57
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 3.5 mos7.78 units on a scaleStandard Error 3.7
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 4.5 mos-5.89 units on a scaleStandard Error 4.16
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 3.5 mos3.81 units on a scaleStandard Error 3.88
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 3.5 mos-10.40 units on a scaleStandard Error 4.1
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 3.5 mos17.01 units on a scaleStandard Error 3.88
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 4.5 mos9.35 units on a scaleStandard Error 3.83
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 0.5 mos (baseline)-0.65 units on a scaleStandard Error 5.92
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 3.5 mos7.54 units on a scaleStandard Error 4.34
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 4.5 mos1.02 units on a scaleStandard Error 3.66
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 2.5 mos2.23 units on a scaleStandard Error 3.65
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 2.5 mos-0.68 units on a scaleStandard Error 3.86
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 2.5 months17.91 units on a scaleStandard Error 3.26
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 0.5 mos (baseline)-1.28 units on a scaleStandard Error 5.33
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 0.5 mos (baseline)-13.35 units on a scaleStandard Error 5.2
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 1.5 mos1.11 units on a scaleStandard Error 4.36
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 1.5 mos11.81 units on a scaleStandard Error 3.28
1M2.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 2.5 mos2.08 units on a scaleStandard Error 3.51
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 3.5 mos-8.07 units on a scaleStandard Error 4.1
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 1.5 mos4.30 units on a scaleStandard Error 4.36
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 2.5 mos6.14 units on a scaleStandard Error 3.65
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 0.5 mos (baseline)0.87 units on a scaleStandard Error 5.92
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 3.5 mos19.56 units on a scaleStandard Error 3.88
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 3.5 mos6.01 units on a scaleStandard Error 3.88
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 4.5 mos3.62 units on a scaleStandard Error 3.66
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 0.5 mos (baseline)-12.46 units on a scaleStandard Error 5.2
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 4.5 mos2.63 units on a scaleStandard Error 3.69
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 1.5 mos-9.68 units on a scaleStandard Error 4.06
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 2.5 mos-6.20 units on a scaleStandard Error 4.39
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 4.5 months19.94 units on a scaleStandard Error 3.01
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 0.5 mos (baseline)-2.02 units on a scaleStandard Error 5.33
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 3.5 mos3.05 units on a scaleStandard Error 3.71
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Celery, 4.5 mos-5.87 units on a scaleStandard Error 4.16
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 1.5 mos4.17 units on a scaleStandard Error 3.75
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 0.5 mos (Baseline)14.57 units on a scaleStandard Error 4.02
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 1.5 mos18.23 units on a scaleStandard Error 3.28
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 2.5 mos6.30 units on a scaleStandard Error 3.51
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 2.5 mos1.02 units on a scaleStandard Error 3.86
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Apple, 2.5 months16.72 units on a scaleStandard Error 3.26
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 3.5 mos3.52 units on a scaleStandard Error 4.34
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 4.5 mos3.58 units on a scaleStandard Error 3.83
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Beet, 1.5 mos3.40 units on a scaleStandard Error 4.58
3M0.5Taste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 0.5 mos (baseline)0.97 units on a scaleStandard Error 5.57
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 0.5 mos (baseline)-4.71 units on a scaleStandard Error 5.15
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Celery, 0.5 mos (baseline)-10.36 units on a scaleStandard Error 5.02
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 1.5 mos10.69 units on a scaleStandard Error 4.22
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Apple, 1.5 mos20.36 units on a scaleStandard Error 3.17
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Beet, 4.5 mos7.89 units on a scaleStandard Error 3.7
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 1.5 mos1.46 units on a scaleStandard Error 3.63
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 4.5 mos2.75 units on a scaleStandard Error 3.57
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 0.5 mos (baseline)11.32 units on a scaleStandard Error 5.38
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Beet, 2.5 mos9.17 units on a scaleStandard Error 3.73
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 4.5 mos7.87 units on a scaleStandard Error 3.54
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 2.5 mos7.57 units on a scaleStandard Error 3.52
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Apple, 3.5 mos19.44 units on a scaleStandard Error 3.75
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Beet, 0.5 mos (baseline)-3.21 units on a scaleStandard Error 5.72
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Celery, 3.5 mos-6.69 units on a scaleStandard Error 3.96
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Beet, 3.5 mos6.82 units on a scaleStandard Error 4.2
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Apple, 4.5 months22.06 units on a scaleStandard Error 2.91
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 3.5 mos1.56 units on a scaleStandard Error 3.58
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Beet, 1.5 mos5.73 units on a scaleStandard Error 4.43
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Celery, 4.5 mos-2.91 units on a scaleStandard Error 4.02
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Celery, 2.5 mos-2.88 units on a scaleStandard Error 4.24
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Apple, 2.5 months19.39 units on a scaleStandard Error 3.15
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Celery, 1.5 mos-5.44 units on a scaleStandard Error 3.92
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Mixed Vegetables, 3.5 mos10.42 units on a scaleStandard Error 3.75
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Apple, 0.5 mos (Baseline)23.72 units on a scaleStandard Error 3.88
ControlTaste Liking Ratings of Vegetable Flavors [Mothers].Carrot, 2.5 mos-2.53 units on a scaleStandard Error 3.39
Comparison: Repeated measures ANOVAs were conducted on maternal gLMS ratings with type of juice and time as the within-subject factors and experimental group as the grouping factorp-value: <0.02ANOVA
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).

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

Population: 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

ArmMeasureGroupValue (MEAN)Dispersion
1M0.5Vegetable Flavor Acceptance [Infants' Intake]Intake of plain cereal in grams56.8 intake in gramsStandard Error 13.2
1M0.5Vegetable Flavor Acceptance [Infants' Intake]Intake of broccoli cereal, grams41.8 intake in gramsStandard Error 12.7
1M0.5Vegetable Flavor Acceptance [Infants' Intake]Intake of carrot cereal in grams78.2 intake in gramsStandard Error 14.8
1M1.5Vegetable Flavor Acceptance [Infants' Intake]Intake of carrot cereal in grams36.6 intake in gramsStandard Error 10
1M1.5Vegetable Flavor Acceptance [Infants' Intake]Intake of plain cereal in grams42.4 intake in gramsStandard Error 12.4
1M1.5Vegetable Flavor Acceptance [Infants' Intake]Intake of broccoli cereal, grams25.5 intake in gramsStandard Error 8.8
1M2.5Vegetable Flavor Acceptance [Infants' Intake]Intake of carrot cereal in grams57.7 intake in gramsStandard Error 19.9
1M2.5Vegetable Flavor Acceptance [Infants' Intake]Intake of plain cereal in grams29.0 intake in gramsStandard Error 8.5
1M2.5Vegetable Flavor Acceptance [Infants' Intake]Intake of broccoli cereal, grams30.9 intake in gramsStandard Error 10.1
3M0.5Vegetable Flavor Acceptance [Infants' Intake]Intake of plain cereal in grams40.7 intake in gramsStandard Error 8.3
3M0.5Vegetable Flavor Acceptance [Infants' Intake]Intake of broccoli cereal, grams34.4 intake in gramsStandard Error 12.4
3M0.5Vegetable Flavor Acceptance [Infants' Intake]Intake of carrot cereal in grams52.2 intake in gramsStandard Error 9.8
ControlVegetable Flavor Acceptance [Infants' Intake]Intake of carrot cereal in grams41.1 intake in gramsStandard Error 7.6
ControlVegetable Flavor Acceptance [Infants' Intake]Intake of plain cereal in grams36.5 intake in gramsStandard Error 6.2
ControlVegetable Flavor Acceptance [Infants' Intake]Intake of broccoli cereal, grams3.04 intake in gramsStandard Error 6.5
Comparison: Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).p-value: 0.02planned comparison
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) .

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
1M0.5Vegetable Flavor Acceptance (Infants' Rate of Feeding)Rate of feeding, broccoli cereal4.8 grams per minuteStandard Error 0.8
1M0.5Vegetable Flavor Acceptance (Infants' Rate of Feeding)Rate of feeding, carrot cereal7.2 grams per minuteStandard Error 1.1
1M0.5Vegetable Flavor Acceptance (Infants' Rate of Feeding)Rate of feeding, plain cereal6.1 grams per minuteStandard Error 0.9
1M1.5Vegetable Flavor Acceptance (Infants' Rate of Feeding)Rate of feeding, carrot cereal3.6 grams per minuteStandard Error 0.8
1M1.5Vegetable Flavor Acceptance (Infants' Rate of Feeding)Rate of feeding, plain cereal3.9 grams per minuteStandard Error 1.1
1M1.5Vegetable Flavor Acceptance (Infants' Rate of Feeding)Rate of feeding, broccoli cereal2.4 grams per minuteStandard Error 0.9
1M2.5Vegetable Flavor Acceptance (Infants' Rate of Feeding)Rate of feeding, broccoli cereal4.5 grams per minuteStandard Error 1
1M2.5Vegetable Flavor Acceptance (Infants' Rate of Feeding)Rate of feeding, carrot cereal4.8 grams per minuteStandard Error 1.3
1M2.5Vegetable Flavor Acceptance (Infants' Rate of Feeding)Rate of feeding, plain cereal4.0 grams per minuteStandard Error 0.8
3M0.5Vegetable Flavor Acceptance (Infants' Rate of Feeding)Rate of feeding, carrot cereal3.9 grams per minuteStandard Error 0.5
3M0.5Vegetable Flavor Acceptance (Infants' Rate of Feeding)Rate of feeding, plain cereal4.3 grams per minuteStandard Error 0.4
3M0.5Vegetable Flavor Acceptance (Infants' Rate of Feeding)Rate of feeding, broccoli cereal3.8 grams per minuteStandard Error 0.9
ControlVegetable Flavor Acceptance (Infants' Rate of Feeding)Rate of feeding, broccoli cereal4.1 grams per minuteStandard Error 0.8
ControlVegetable Flavor Acceptance (Infants' Rate of Feeding)Rate of feeding, carrot cereal3.9 grams per minuteStandard Error 0.6
ControlVegetable Flavor Acceptance (Infants' Rate of Feeding)Rate of feeding, plain cereal4.9 grams per minuteStandard Error 0.6
Comparison: Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).p-value: <0.02planned comparison
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).

Time frame: Once a month from ages 0.5 - 4.5 months, 10.5 months

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
1M0.5Growth of InfantsWeight for Length Z: 2.5 months0.04 Z scoreStandard Error 0.26
1M0.5Growth of InfantsWeight for Length Z: 0.5 months-0.69 Z scoreStandard Error 0.24
1M0.5Growth of InfantsWeight for Length Z: 3.5 months0.02 Z scoreStandard Error 0.28
1M0.5Growth of InfantsWeight for Length Z: 1.5 months-0.07 Z scoreStandard Error 0.27
1M0.5Growth of InfantsWeight for Length Z, 10.5 months0.56 Z scoreStandard Error 0.24
1M0.5Growth of InfantsWeight for Length Z: 4.5 months0.20 Z scoreStandard Error 0.25
1M1.5Growth of InfantsWeight for Length Z: 2.5 months0.13 Z scoreStandard Error 0.29
1M1.5Growth of InfantsWeight for Length Z: 3.5 months0.12 Z scoreStandard Error 0.31
1M1.5Growth of InfantsWeight for Length Z, 10.5 months0.67 Z scoreStandard Error 0.26
1M1.5Growth of InfantsWeight for Length Z: 1.5 months0.42 Z scoreStandard Error 0.28
1M1.5Growth of InfantsWeight for Length Z: 0.5 months0.04 Z scoreStandard Error 0.26
1M1.5Growth of InfantsWeight for Length Z: 4.5 months0.05 Z scoreStandard Error 0.27
1M2.5Growth of InfantsWeight for Length Z: 4.5 months-0.67 Z scoreStandard Error 0.27
1M2.5Growth of InfantsWeight for Length Z, 10.5 months0.23 Z scoreStandard Error 0.26
1M2.5Growth of InfantsWeight for Length Z: 1.5 months-0.49 Z scoreStandard Error 0.29
1M2.5Growth of InfantsWeight for Length Z: 2.5 months-0.64 Z scoreStandard Error 0.29
1M2.5Growth of InfantsWeight for Length Z: 0.5 months-0.40 Z scoreStandard Error 0.27
1M2.5Growth of InfantsWeight for Length Z: 3.5 months-0.68 Z scoreStandard Error 0.31
3M0.5Growth of InfantsWeight for Length Z: 4.5 months0.43 Z scoreStandard Error 0.27
3M0.5Growth of InfantsWeight for Length Z: 3.5 months0.63 Z scoreStandard Error 0.31
3M0.5Growth of InfantsWeight for Length Z: 0.5 months0.10 Z scoreStandard Error 0.27
3M0.5Growth of InfantsWeight for Length Z: 1.5 months0.56 Z scoreStandard Error 0.29
3M0.5Growth of InfantsWeight for Length Z, 10.5 months0.61 Z scoreStandard Error 0.26
3M0.5Growth of InfantsWeight for Length Z: 2.5 months0.45 Z scoreStandard Error 0.29
ControlGrowth of InfantsWeight for Length Z: 2.5 months0.15 Z scoreStandard Error 0.28
ControlGrowth of InfantsWeight for Length Z: 0.5 months-0.56 Z scoreStandard Error 0.26
ControlGrowth of InfantsWeight for Length Z: 1.5 months0.14 Z scoreStandard Error 0.28
ControlGrowth of InfantsWeight for Length Z, 10.5 months0.54 Z scoreStandard Error 0.25
ControlGrowth of InfantsWeight for Length Z: 3.5 months0.08 Z scoreStandard Error 0.3
ControlGrowth of InfantsWeight for Length Z: 4.5 months0.30 Z scoreStandard Error 0.27
Comparison: General linear models were conducted on WLZ scores with time as the within-subjects factor and Group as the between-subjects factor to determine there were differences in growth of the infants over time. This was not done to test hypothesis but to monitor growth of infants during course of trial.p-value: <0.05ANOVA
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).

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

Population: 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

ArmMeasureGroupValue (MEAN)Dispersion
1M0.5Maternal PerceptionsRating of infant enjoyment, plain cerea5.4 Score on a scaleStandard Error 0.6
1M0.5Maternal PerceptionsRating of infant enjoyment, broccoli cere4.2 Score on a scaleStandard Error 0.7
1M0.5Maternal PerceptionsRating of infant enjoyment, carrot cereal6.0 Score on a scaleStandard Error 0.7
1M1.5Maternal PerceptionsRating of infant enjoyment, carrot cereal4.7 Score on a scaleStandard Error 0.7
1M1.5Maternal PerceptionsRating of infant enjoyment, plain cerea4.6 Score on a scaleStandard Error 0.8
1M1.5Maternal PerceptionsRating of infant enjoyment, broccoli cere2.9 Score on a scaleStandard Error 0.6
1M2.5Maternal PerceptionsRating of infant enjoyment, carrot cereal7.1 Score on a scaleStandard Error 0.4
1M2.5Maternal PerceptionsRating of infant enjoyment, plain cerea4.1 Score on a scaleStandard Error 0.9
1M2.5Maternal PerceptionsRating of infant enjoyment, broccoli cere4.7 Score on a scaleStandard Error 0.7
3M0.5Maternal PerceptionsRating of infant enjoyment, plain cerea5.2 Score on a scaleStandard Error 0.6
3M0.5Maternal PerceptionsRating of infant enjoyment, broccoli cere4.3 Score on a scaleStandard Error 0.6
3M0.5Maternal PerceptionsRating of infant enjoyment, carrot cereal6.1 Score on a scaleStandard Error 0.5
ControlMaternal PerceptionsRating of infant enjoyment, carrot cereal6.1 Score on a scaleStandard Error 0.7
ControlMaternal PerceptionsRating of infant enjoyment, plain cerea3.9 Score on a scaleStandard Error 0.5
ControlMaternal PerceptionsRating of infant enjoyment, broccoli cere4.1 Score on a scaleStandard Error 0.7
Comparison: Separate analyses of variance with a priori contrasts specified 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).p-value: <0.02planned comparison

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026