N/A
N=97
Sensitive Periods in Human Flavor Learning
Development
Bottom Line
View on ClinicalTrials.gov: NCT01667549 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Vegetable Flavor Acceptance [Infants' Intake] — 56.8; 42.4; 29.0; 40.7 intake in grams — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Timing of Diet and Flavor Experience (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Monell Chemical Senses Center
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vegetable Flavor Acceptance [Infants' Intake] |
56.8; 42.4; 29.0; 40.7; 36.5; 78.2 | 0.02 sig |
| PRIMARY Taste Liking Ratings of Vegetable Flavors [Mothers]. |
-0.07; -3.35; -1.28; -2.02; -4.71; 6.21 | <0.02 sig |
| PRIMARY Vegetable Flavor Acceptance (Infants' Rate of Feeding) |
6.1; 3.9; 4.0; 4.3; 4.9; 7.2 | <0.02 sig |
| SECONDARY Maternal Perceptions |
5.4; 4.6; 4.1; 5.2; 3.9; 6.0 | <0.02 sig |
| SECONDARY Growth of Infants |
-0.69; 0.04; -0.40; 0.10; -0.56; -0.07 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy, term infants and their mothers
- Infants 2 wks (+/- 2 wk of age)
- Mothers and infants exclusively breastfeeding or exclusively feeding a cows-milk based formula
- Mothers must be older than 18 years of age
Exclusion Criteria
- Infants who were preterm or have medical conditions that interfere with feeding or eating
- Mothers who had gestational diabetes or are diagnosed with a major illness requiring treatment or surgery
- Mothers who will be going back to work full-time before the infant is 4 months old
- Mothers who are allergic to any vegetables
- Subjects will not be excluded because of economic status, gender, race or ethnicity.
Data sourced from ClinicalTrials.gov (NCT01667549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.