Trial Outcomes & Findings for Sensitive Periods in Human Flavor Learning (NCT NCT01667549)

NCT ID: NCT01667549

Last Updated: 2019-12-09

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

97 participants

Primary outcome timeframe

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

Results posted on

2019-12-09

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure
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.
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.
1M2.5
Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age
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.
Control
Mothers will not receive the intervention.
Overall Study
STARTED
20
20
21
20
16
Overall Study
COMPLETED
17
15
14
14
15
Overall Study
NOT COMPLETED
3
5
7
6
1

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
1M2.5
Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age
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.
Control
Mothers will not receive the intervention.
Overall Study
Withdrawal by Subject
3
5
7
6
1

Baseline Characteristics

Dyads consists of mothers and their infants and different measures were obtained from each.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
1M0.5
n=20 Participants
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.
1M1.5
n=20 Participants
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.
1M2.5
n=21 Participants
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.
3M0.5
n=20 Participants
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.
Control
n=16 Participants
Mothers will not receive the intervention.
Total
n=97 Participants
Total of all reporting groups
Age, Continuous
Infants' Age in months
0.5 Months
STANDARD_DEVIATION 0.1 • n=5 Participants • Dyads consists of mothers and their infants and different measures were obtained from each.
0.6 Months
STANDARD_DEVIATION 0.1 • n=7 Participants • Dyads consists of mothers and their infants and different measures were obtained from each.
0.6 Months
STANDARD_DEVIATION 0.1 • n=5 Participants • Dyads consists of mothers and their infants and different measures were obtained from each.
0.6 Months
STANDARD_DEVIATION 0.1 • n=4 Participants • Dyads consists of mothers and their infants and different measures were obtained from each.
0.5 Months
STANDARD_DEVIATION 0.1 • n=21 Participants • Dyads consists of mothers and their infants and different measures were obtained from each.
0.5 Months
STANDARD_DEVIATION 0.1 • n=8 Participants • Dyads consists of mothers and their infants and different measures were obtained from each.
Age, Continuous
32.5 Mothers' Age in years
STANDARD_DEVIATION 4.4 • n=5 Participants
30.5 Mothers' Age in years
STANDARD_DEVIATION 6.2 • n=7 Participants
29.8 Mothers' Age in years
STANDARD_DEVIATION 5.2 • n=5 Participants
29.9 Mothers' Age in years
STANDARD_DEVIATION 5.1 • n=4 Participants
31.7 Mothers' Age in years
STANDARD_DEVIATION 5.9 • n=21 Participants
30.8 Mothers' Age in years
STANDARD_DEVIATION 5.4 • n=8 Participants
Sex: Female, Male
Sex of Infants · Female
10 Participants
n=5 Participants • Infants are reported separately from mothers
11 Participants
n=7 Participants • Infants are reported separately from mothers
9 Participants
n=5 Participants • Infants are reported separately from mothers
13 Participants
n=4 Participants • Infants are reported separately from mothers
7 Participants
n=21 Participants • Infants are reported separately from mothers
50 Participants
n=8 Participants • Infants are reported separately from mothers
Sex: Female, Male
Sex of Infants · Male
10 Participants
n=5 Participants • Infants are reported separately from mothers
9 Participants
n=7 Participants • Infants are reported separately from mothers
12 Participants
n=5 Participants • Infants are reported separately from mothers
7 Participants
n=4 Participants • Infants are reported separately from mothers
9 Participants
n=21 Participants • Infants are reported separately from mothers
47 Participants
n=8 Participants • Infants are reported separately from mothers
Sex: Female, Male
Sex of Mothers · Female
20 Participants
n=5 Participants • Infants are reported separately from mothers
20 Participants
n=7 Participants • Infants are reported separately from mothers
21 Participants
n=5 Participants • Infants are reported separately from mothers
20 Participants
n=4 Participants • Infants are reported separately from mothers
16 Participants
n=21 Participants • Infants are reported separately from mothers
97 Participants
n=8 Participants • Infants are reported separately from mothers
Sex: Female, Male
Sex of Mothers · Male
0 Participants
n=5 Participants • Infants are reported separately from mothers
0 Participants
n=7 Participants • Infants are reported separately from mothers
0 Participants
n=5 Participants • Infants are reported separately from mothers
0 Participants
n=4 Participants • Infants are reported separately from mothers
0 Participants
n=21 Participants • Infants are reported separately from mothers
0 Participants
n=8 Participants • Infants are reported separately from mothers
Ethnicity (NIH/OMB)
Infants · Hispanic or Latino
2 Participants
n=5 Participants • Infants are reported separately from mothers.
4 Participants
n=7 Participants • Infants are reported separately from mothers.
4 Participants
n=5 Participants • Infants are reported separately from mothers.
3 Participants
n=4 Participants • Infants are reported separately from mothers.
1 Participants
n=21 Participants • Infants are reported separately from mothers.
14 Participants
n=8 Participants • Infants are reported separately from mothers.
Ethnicity (NIH/OMB)
Infants · Not Hispanic or Latino
18 Participants
n=5 Participants • Infants are reported separately from mothers.
16 Participants
n=7 Participants • Infants are reported separately from mothers.
17 Participants
n=5 Participants • Infants are reported separately from mothers.
17 Participants
n=4 Participants • Infants are reported separately from mothers.
15 Participants
n=21 Participants • Infants are reported separately from mothers.
83 Participants
n=8 Participants • Infants are reported separately from mothers.
Ethnicity (NIH/OMB)
Infants · Unknown or Not Reported
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=7 Participants • Infants are reported separately from mothers.
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=4 Participants • Infants are reported separately from mothers.
0 Participants
n=21 Participants • Infants are reported separately from mothers.
0 Participants
n=8 Participants • Infants are reported separately from mothers.
Ethnicity (NIH/OMB)
Mothers · Hispanic or Latino
2 Participants
n=5 Participants • Infants are reported separately from mothers.
3 Participants
n=7 Participants • Infants are reported separately from mothers.
2 Participants
n=5 Participants • Infants are reported separately from mothers.
2 Participants
n=4 Participants • Infants are reported separately from mothers.
0 Participants
n=21 Participants • Infants are reported separately from mothers.
9 Participants
n=8 Participants • Infants are reported separately from mothers.
Ethnicity (NIH/OMB)
Mothers · Not Hispanic or Latino
18 Participants
n=5 Participants • Infants are reported separately from mothers.
17 Participants
n=7 Participants • Infants are reported separately from mothers.
19 Participants
n=5 Participants • Infants are reported separately from mothers.
18 Participants
n=4 Participants • Infants are reported separately from mothers.
16 Participants
n=21 Participants • Infants are reported separately from mothers.
88 Participants
n=8 Participants • Infants are reported separately from mothers.
Ethnicity (NIH/OMB)
Mothers · Unknown or Not Reported
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=7 Participants • Infants are reported separately from mothers.
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=4 Participants • Infants are reported separately from mothers.
0 Participants
n=21 Participants • Infants are reported separately from mothers.
0 Participants
n=8 Participants • Infants are reported separately from mothers.
Race (NIH/OMB)
Infants · American Indian or Alaska Native
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=7 Participants • Infants are reported separately from mothers.
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=4 Participants • Infants are reported separately from mothers.
0 Participants
n=21 Participants • Infants are reported separately from mothers.
0 Participants
n=8 Participants • Infants are reported separately from mothers.
Race (NIH/OMB)
Infants · Asian
0 Participants
n=5 Participants • Infants are reported separately from mothers.
1 Participants
n=7 Participants • Infants are reported separately from mothers.
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=4 Participants • Infants are reported separately from mothers.
1 Participants
n=21 Participants • Infants are reported separately from mothers.
2 Participants
n=8 Participants • Infants are reported separately from mothers.
Race (NIH/OMB)
Infants · Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=7 Participants • Infants are reported separately from mothers.
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=4 Participants • Infants are reported separately from mothers.
0 Participants
n=21 Participants • Infants are reported separately from mothers.
0 Participants
n=8 Participants • Infants are reported separately from mothers.
Race (NIH/OMB)
Infants · Black or African American
3 Participants
n=5 Participants • Infants are reported separately from mothers.
7 Participants
n=7 Participants • Infants are reported separately from mothers.
8 Participants
n=5 Participants • Infants are reported separately from mothers.
8 Participants
n=4 Participants • Infants are reported separately from mothers.
5 Participants
n=21 Participants • Infants are reported separately from mothers.
31 Participants
n=8 Participants • Infants are reported separately from mothers.
Race (NIH/OMB)
Infants · White
13 Participants
n=5 Participants • Infants are reported separately from mothers.
9 Participants
n=7 Participants • Infants are reported separately from mothers.
9 Participants
n=5 Participants • Infants are reported separately from mothers.
9 Participants
n=4 Participants • Infants are reported separately from mothers.
9 Participants
n=21 Participants • Infants are reported separately from mothers.
49 Participants
n=8 Participants • Infants are reported separately from mothers.
Race (NIH/OMB)
Infants · More than one race
4 Participants
n=5 Participants • Infants are reported separately from mothers.
3 Participants
n=7 Participants • Infants are reported separately from mothers.
4 Participants
n=5 Participants • Infants are reported separately from mothers.
3 Participants
n=4 Participants • Infants are reported separately from mothers.
1 Participants
n=21 Participants • Infants are reported separately from mothers.
15 Participants
n=8 Participants • Infants are reported separately from mothers.
Race (NIH/OMB)
Infants · Unknown or Not Reported
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=7 Participants • Infants are reported separately from mothers.
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=4 Participants • Infants are reported separately from mothers.
0 Participants
n=21 Participants • Infants are reported separately from mothers.
0 Participants
n=8 Participants • Infants are reported separately from mothers.
Race (NIH/OMB)
Mothers · American Indian or Alaska Native
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=7 Participants • Infants are reported separately from mothers.
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=4 Participants • Infants are reported separately from mothers.
0 Participants
n=21 Participants • Infants are reported separately from mothers.
0 Participants
n=8 Participants • Infants are reported separately from mothers.
Race (NIH/OMB)
Mothers · Asian
0 Participants
n=5 Participants • Infants are reported separately from mothers.
1 Participants
n=7 Participants • Infants are reported separately from mothers.
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=4 Participants • Infants are reported separately from mothers.
1 Participants
n=21 Participants • Infants are reported separately from mothers.
2 Participants
n=8 Participants • Infants are reported separately from mothers.
Race (NIH/OMB)
Mothers · Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=7 Participants • Infants are reported separately from mothers.
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=4 Participants • Infants are reported separately from mothers.
0 Participants
n=21 Participants • Infants are reported separately from mothers.
0 Participants
n=8 Participants • Infants are reported separately from mothers.
Race (NIH/OMB)
Mothers · Black or African American
4 Participants
n=5 Participants • Infants are reported separately from mothers.
7 Participants
n=7 Participants • Infants are reported separately from mothers.
10 Participants
n=5 Participants • Infants are reported separately from mothers.
9 Participants
n=4 Participants • Infants are reported separately from mothers.
5 Participants
n=21 Participants • Infants are reported separately from mothers.
35 Participants
n=8 Participants • Infants are reported separately from mothers.
Race (NIH/OMB)
Mothers · White
14 Participants
n=5 Participants • Infants are reported separately from mothers.
9 Participants
n=7 Participants • Infants are reported separately from mothers.
11 Participants
n=5 Participants • Infants are reported separately from mothers.
10 Participants
n=4 Participants • Infants are reported separately from mothers.
10 Participants
n=21 Participants • Infants are reported separately from mothers.
54 Participants
n=8 Participants • Infants are reported separately from mothers.
Race (NIH/OMB)
Mothers · More than one race
2 Participants
n=5 Participants • Infants are reported separately from mothers.
3 Participants
n=7 Participants • Infants are reported separately from mothers.
0 Participants
n=5 Participants • Infants are reported separately from mothers.
1 Participants
n=4 Participants • Infants are reported separately from mothers.
0 Participants
n=21 Participants • Infants are reported separately from mothers.
6 Participants
n=8 Participants • Infants are reported separately from mothers.
Race (NIH/OMB)
Mothers · Unknown or Not Reported
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=7 Participants • Infants are reported separately from mothers.
0 Participants
n=5 Participants • Infants are reported separately from mothers.
0 Participants
n=4 Participants • Infants are reported separately from mothers.
0 Participants
n=21 Participants • Infants are reported separately from mothers.
0 Participants
n=8 Participants • Infants are reported separately from mothers.
Genotype, TAS2R38 taste gene [secondary outcome]
Infants · TAS2R38 genotype, AA [non taster]
7 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
6 Participants
n=7 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
3 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
7 Participants
n=4 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
8 Participants
n=21 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
31 Participants
n=8 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
Genotype, TAS2R38 taste gene [secondary outcome]
Infants · TAS2R38 genotype AP [taster, heterozygote]
12 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
8 Participants
n=7 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
11 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
7 Participants
n=4 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
5 Participants
n=21 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
43 Participants
n=8 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
Genotype, TAS2R38 taste gene [secondary outcome]
Infants · TAS2R38 genotype PP [taster]
1 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
6 Participants
n=7 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
7 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
6 Participants
n=4 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
2 Participants
n=21 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
22 Participants
n=8 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
Genotype, TAS2R38 taste gene [secondary outcome]
Infants · Genotyping unsuccessful
0 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
0 Participants
n=7 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
0 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
0 Participants
n=4 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
1 Participants
n=21 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
1 Participants
n=8 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
Genotype, TAS2R38 taste gene [secondary outcome]
Mothers · TAS2R38 genotype, AA [non taster]
4 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
5 Participants
n=7 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
5 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
7 Participants
n=4 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
11 Participants
n=21 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
32 Participants
n=8 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
Genotype, TAS2R38 taste gene [secondary outcome]
Mothers · TAS2R38 genotype AP [taster, heterozygote]
12 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
9 Participants
n=7 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
9 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
8 Participants
n=4 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
3 Participants
n=21 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
41 Participants
n=8 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
Genotype, TAS2R38 taste gene [secondary outcome]
Mothers · TAS2R38 genotype PP [taster]
4 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
6 Participants
n=7 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
7 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
5 Participants
n=4 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
2 Participants
n=21 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
24 Participants
n=8 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
Genotype, TAS2R38 taste gene [secondary outcome]
Mothers · Genotyping unsuccessful
0 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
0 Participants
n=7 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
0 Participants
n=5 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
0 Participants
n=4 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
0 Participants
n=21 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.
0 Participants
n=8 Participants • Infants are reported separately from their mothers. Genotyping was unsuccessful for one infant.

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure
1M0.5
n=17 Participants
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.
1M1.5
n=15 Participants
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.
1M2.5
n=14 Participants
Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age
3M0.5
n=14 Participants
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.
Control
n=15 Participants
Mothers will not receive the intervention.
Vegetable Flavor Acceptance [Infants' Intake]
Intake of plain cereal in grams
56.8 intake in grams
Standard Error 13.2
42.4 intake in grams
Standard Error 12.4
29.0 intake in grams
Standard Error 8.5
40.7 intake in grams
Standard Error 8.3
36.5 intake in grams
Standard Error 6.2
Vegetable Flavor Acceptance [Infants' Intake]
Intake of carrot cereal in grams
78.2 intake in grams
Standard Error 14.8
36.6 intake in grams
Standard Error 10.0
57.7 intake in grams
Standard Error 19.9
52.2 intake in grams
Standard Error 9.8
41.1 intake in grams
Standard Error 7.6
Vegetable Flavor Acceptance [Infants' Intake]
Intake of broccoli cereal, grams
41.8 intake in grams
Standard Error 12.7
25.5 intake in grams
Standard Error 8.8
30.9 intake in grams
Standard Error 10.1
34.4 intake in grams
Standard Error 12.4
3.04 intake in grams
Standard Error 6.5

PRIMARY outcome

Timeframe: Monthly, 0.5 to 4.5 months

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

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).

Outcome measures

Outcome measures
Measure
1M0.5
n=17 Participants
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.
1M1.5
n=15 Participants
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.
1M2.5
n=14 Participants
Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age
3M0.5
n=14 Participants
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.
Control
n=15 Participants
Mothers will not receive the intervention.
Taste Liking Ratings of Vegetable Flavors [Mothers].
Apple, 3.5 mos
13.39 units on a scale
Standard Error 3.52
22.56 units on a scale
Standard Error 3.88
17.01 units on a scale
Standard Error 3.88
19.56 units on a scale
Standard Error 3.88
19.44 units on a scale
Standard Error 3.75
Taste Liking Ratings of Vegetable Flavors [Mothers].
Apple, 4.5 months
15.89 units on a scale
Standard Error 2.73
19.87 units on a scale
Standard Error 3.01
15.45 units on a scale
Standard Error 3.01
19.94 units on a scale
Standard Error 3.01
22.06 units on a scale
Standard Error 2.91
Taste Liking Ratings of Vegetable Flavors [Mothers].
Carrot, 0.5 mos (baseline)
-0.07 units on a scale
Standard Error 4.84
-3.35 units on a scale
Standard Error 5.15
-1.28 units on a scale
Standard Error 5.33
-2.02 units on a scale
Standard Error 5.33
-4.71 units on a scale
Standard Error 5.15
Taste Liking Ratings of Vegetable Flavors [Mothers].
Carrot, 1.5 mos
6.21 units on a scale
Standard Error 3.41
1.28 units on a scale
Standard Error 3.63
3.91 units on a scale
Standard Error 3.75
4.17 units on a scale
Standard Error 3.75
1.46 units on a scale
Standard Error 3.63
Taste Liking Ratings of Vegetable Flavors [Mothers].
Carrot, 2.5 mos
5.67 units on a scale
Standard Error 3.19
3.51 units on a scale
Standard Error 3.39
2.08 units on a scale
Standard Error 3.51
6.30 units on a scale
Standard Error 3.51
-2.53 units on a scale
Standard Error 3.39
Taste Liking Ratings of Vegetable Flavors [Mothers].
Carrot, 3.5 mos
3.10 units on a scale
Standard Error 3.36
6.20 units on a scale
Standard Error 3.71
7.78 units on a scale
Standard Error 3.7
3.05 units on a scale
Standard Error 3.71
1.56 units on a scale
Standard Error 3.58
Taste Liking Ratings of Vegetable Flavors [Mothers].
Carrot, 4.5 mos
5.86 units on a scale
Standard Error 3.35
4.82 units on a scale
Standard Error 3.69
6.20 units on a scale
Standard Error 3.69
2.63 units on a scale
Standard Error 3.69
2.75 units on a scale
Standard Error 3.57
Taste Liking Ratings of Vegetable Flavors [Mothers].
Beet, 0.5 mos (baseline)
5.81 units on a scale
Standard Error 5.37
1.18 units on a scale
Standard Error 5.72
-0.65 units on a scale
Standard Error 5.92
0.87 units on a scale
Standard Error 5.92
-3.21 units on a scale
Standard Error 5.72
Taste Liking Ratings of Vegetable Flavors [Mothers].
Beet, 1.5 mos
3.13 units on a scale
Standard Error 4.16
9.35 units on a scale
Standard Error 4.43
-2.20 units on a scale
Standard Error 4.58
3.40 units on a scale
Standard Error 4.58
5.73 units on a scale
Standard Error 4.43
Taste Liking Ratings of Vegetable Flavors [Mothers].
Beet, 2.5 mos
9.29 units on a scale
Standard Error 3.50
6.41 units on a scale
Standard Error 3.73
-0.68 units on a scale
Standard Error 3.86
1.02 units on a scale
Standard Error 3.86
9.17 units on a scale
Standard Error 3.73
Taste Liking Ratings of Vegetable Flavors [Mothers].
Beet, 3.5 mos
10.87 units on a scale
Standard Error 3.94
7.74 units on a scale
Standard Error 4.34
7.54 units on a scale
Standard Error 4.34
3.52 units on a scale
Standard Error 4.34
6.82 units on a scale
Standard Error 4.20
Taste Liking Ratings of Vegetable Flavors [Mothers].
Beet, 4.5 mos
8.63 units on a scale
Standard Error 3.48
10.34 units on a scale
Standard Error 3.83
9.35 units on a scale
Standard Error 3.83
3.58 units on a scale
Standard Error 3.83
7.89 units on a scale
Standard Error 3.70
Taste Liking Ratings of Vegetable Flavors [Mothers].
Mixed Vegetables, 0.5 mos (baseline)
1.22 units on a scale
Standard Error 5.05
0.20 units on a scale
Standard Error 5.38
0.82 units on a scale
Standard Error 5.57
0.97 units on a scale
Standard Error 5.57
11.32 units on a scale
Standard Error 5.38
Taste Liking Ratings of Vegetable Flavors [Mothers].
Mixed Vegetables, 1.5 mos
9.48 units on a scale
Standard Error 3.96
0.18 units on a scale
Standard Error 4.22
1.11 units on a scale
Standard Error 4.36
4.30 units on a scale
Standard Error 4.36
10.69 units on a scale
Standard Error 4.22
Taste Liking Ratings of Vegetable Flavors [Mothers].
Mixed Vegetables, 2.5 mos
10.19 units on a scale
Standard Error 3.31
6.32 units on a scale
Standard Error 3.52
2.23 units on a scale
Standard Error 3.65
6.14 units on a scale
Standard Error 3.65
7.57 units on a scale
Standard Error 3.52
Taste Liking Ratings of Vegetable Flavors [Mothers].
Mixed Vegetables, 3.5 mos
7.00 units on a scale
Standard Error 3.52
5.69 units on a scale
Standard Error 3.88
3.81 units on a scale
Standard Error 3.88
6.01 units on a scale
Standard Error 3.88
10.42 units on a scale
Standard Error 3.75
Taste Liking Ratings of Vegetable Flavors [Mothers].
Mixed Vegetables, 4.5 mos
8.40 units on a scale
Standard Error 3.32
6.83 units on a scale
Standard Error 3.66
1.02 units on a scale
Standard Error 3.66
3.62 units on a scale
Standard Error 3.66
7.87 units on a scale
Standard Error 3.54
Taste Liking Ratings of Vegetable Flavors [Mothers].
Celery, 0.5 mos (baseline)
0.59 units on a scale
Standard Error 4.72
-5.33 units on a scale
Standard Error 5.02
-13.35 units on a scale
Standard Error 5.20
-12.46 units on a scale
Standard Error 5.20
-10.36 units on a scale
Standard Error 5.02
Taste Liking Ratings of Vegetable Flavors [Mothers].
Celery, 1.5 mos
-3.93 units on a scale
Standard Error 3.86
-0.90 units on a scale
Standard Error 3.92
-13.48 units on a scale
Standard Error 4.06
-9.68 units on a scale
Standard Error 4.06
-5.44 units on a scale
Standard Error 3.92
Taste Liking Ratings of Vegetable Flavors [Mothers].
Celery, 2.5 mos
-0.92 units on a scale
Standard Error 3.99
-0.51 units on a scale
Standard Error 4.24
-3.01 units on a scale
Standard Error 4.39
-6.20 units on a scale
Standard Error 4.39
-2.88 units on a scale
Standard Error 4.24
Taste Liking Ratings of Vegetable Flavors [Mothers].
Celery, 3.5 mos
-5.12 units on a scale
Standard Error 3.72
1.07 units on a scale
Standard Error 4.10
-10.40 units on a scale
Standard Error 4.10
-8.07 units on a scale
Standard Error 4.10
-6.69 units on a scale
Standard Error 3.96
Taste Liking Ratings of Vegetable Flavors [Mothers].
Celery, 4.5 mos
-6.15 units on a scale
Standard Error 3.77
-1.44 units on a scale
Standard Error 4.16
-5.89 units on a scale
Standard Error 4.16
-5.87 units on a scale
Standard Error 4.16
-2.91 units on a scale
Standard Error 4.02
Taste Liking Ratings of Vegetable Flavors [Mothers].
Apple, 0.5 mos (Baseline)
17.85 units on a scale
Standard Error 3.64
17.48 units on a scale
Standard Error 3.88
22.41 units on a scale
Standard Error 4.02
14.57 units on a scale
Standard Error 4.02
23.72 units on a scale
Standard Error 3.88
Taste Liking Ratings of Vegetable Flavors [Mothers].
Apple, 1.5 mos
17.04 units on a scale
Standard Error 2.98
20.08 units on a scale
Standard Error 3.17
11.81 units on a scale
Standard Error 3.28
18.23 units on a scale
Standard Error 3.28
20.36 units on a scale
Standard Error 3.17
Taste Liking Ratings of Vegetable Flavors [Mothers].
Apple, 2.5 months
18.09 units on a scale
Standard Error 2.95
15.97 units on a scale
Standard Error 3.15
17.91 units on a scale
Standard Error 3.26
16.72 units on a scale
Standard Error 3.26
19.39 units on a scale
Standard Error 3.15

PRIMARY outcome

Timeframe: 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.

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) .

Outcome measures

Outcome measures
Measure
1M0.5
n=17 Participants
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.
1M1.5
n=15 Participants
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.
1M2.5
n=14 Participants
Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age
3M0.5
n=14 Participants
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.
Control
n=15 Participants
Mothers will not receive the intervention.
Vegetable Flavor Acceptance (Infants' Rate of Feeding)
Rate of feeding, carrot cereal
7.2 grams per minute
Standard Error 1.1
3.6 grams per minute
Standard Error 0.8
4.8 grams per minute
Standard Error 1.3
3.9 grams per minute
Standard Error 0.5
3.9 grams per minute
Standard Error 0.6
Vegetable Flavor Acceptance (Infants' Rate of Feeding)
Rate of feeding, plain cereal
6.1 grams per minute
Standard Error 0.9
3.9 grams per minute
Standard Error 1.1
4.0 grams per minute
Standard Error 0.8
4.3 grams per minute
Standard Error 0.4
4.9 grams per minute
Standard Error 0.6
Vegetable Flavor Acceptance (Infants' Rate of Feeding)
Rate of feeding, broccoli cereal
4.8 grams per minute
Standard Error 0.8
2.4 grams per minute
Standard Error 0.9
4.5 grams per minute
Standard Error 1.0
3.8 grams per minute
Standard Error 0.9
4.1 grams per minute
Standard Error 0.8

SECONDARY outcome

Timeframe: 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

Mothers rated infants' enjoyment of the taste of the cereal (9-point scale); aratings range from 1 (extreme dislike) to 9 (extreme like).

Outcome measures

Outcome measures
Measure
1M0.5
n=17 Participants
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.
1M1.5
n=15 Participants
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.
1M2.5
n=14 Participants
Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age
3M0.5
n=14 Participants
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.
Control
n=15 Participants
Mothers will not receive the intervention.
Maternal Perceptions
Rating of infant enjoyment, plain cerea
5.4 Score on a scale
Standard Error 0.6
4.6 Score on a scale
Standard Error 0.8
4.1 Score on a scale
Standard Error 0.9
5.2 Score on a scale
Standard Error 0.6
3.9 Score on a scale
Standard Error 0.5
Maternal Perceptions
Rating of infant enjoyment, carrot cereal
6.0 Score on a scale
Standard Error 0.7
4.7 Score on a scale
Standard Error 0.7
7.1 Score on a scale
Standard Error 0.4
6.1 Score on a scale
Standard Error 0.5
6.1 Score on a scale
Standard Error 0.7
Maternal Perceptions
Rating of infant enjoyment, broccoli cere
4.2 Score on a scale
Standard Error 0.7
2.9 Score on a scale
Standard Error 0.6
4.7 Score on a scale
Standard Error 0.7
4.3 Score on a scale
Standard Error 0.6
4.1 Score on a scale
Standard Error 0.7

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
1M0.5
n=17 Participants
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.
1M1.5
n=15 Participants
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.
1M2.5
n=14 Participants
Mothers will receive the intervention for one month beginning when their infants are 2.5 months of age
3M0.5
n=14 Participants
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.
Control
n=15 Participants
Mothers will not receive the intervention.
Growth of Infants
Weight for Length Z: 0.5 months
-0.69 Z score
Standard Error 0.24
0.04 Z score
Standard Error 0.26
-0.40 Z score
Standard Error 0.27
0.10 Z score
Standard Error 0.27
-0.56 Z score
Standard Error 0.26
Growth of Infants
Weight for Length Z: 1.5 months
-0.07 Z score
Standard Error 0.27
0.42 Z score
Standard Error 0.28
-0.49 Z score
Standard Error 0.29
0.56 Z score
Standard Error 0.29
0.14 Z score
Standard Error 0.28
Growth of Infants
Weight for Length Z: 2.5 months
0.04 Z score
Standard Error 0.26
0.13 Z score
Standard Error 0.29
-0.64 Z score
Standard Error 0.29
0.45 Z score
Standard Error 0.29
0.15 Z score
Standard Error 0.28
Growth of Infants
Weight for Length Z: 3.5 months
0.02 Z score
Standard Error 0.28
0.12 Z score
Standard Error 0.31
-0.68 Z score
Standard Error 0.31
0.63 Z score
Standard Error 0.31
0.08 Z score
Standard Error 0.30
Growth of Infants
Weight for Length Z: 4.5 months
0.20 Z score
Standard Error 0.25
0.05 Z score
Standard Error 0.27
-0.67 Z score
Standard Error 0.27
0.43 Z score
Standard Error 0.27
0.30 Z score
Standard Error 0.27
Growth of Infants
Weight for Length Z, 10.5 months
0.56 Z score
Standard Error 0.24
0.67 Z score
Standard Error 0.26
0.23 Z score
Standard Error 0.26
0.61 Z score
Standard Error 0.26
0.54 Z score
Standard Error 0.25

Adverse Events

1M0.5

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

1M1.5

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

1M2.5

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

3M0.5

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julia A. Mennella, PhD; Study Principal Investigator

Monell Chemical Senses Center

Phone: 267-519-4880

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place