- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03043118
Children's Taste Study to Increase Vegetable Intake in Preschoolers (CTS)
April 4, 2022 updated by: Kathleen Loralee Keller, Penn State University
A Pilot Study to Test the Influence of Vegetable Flavor Variety Using Herbs and Spices on Preschool Children's Vegetable Intake
Studies have shown that when exposed to a variety of food and flavor options people tend to consume more than when only one item is presented.
This strategy has been used to increase vegetable intake in adults and during snacktime in children.
Increasing vegetable consumption in children is important because higher vegetable intake has been associated with reduced risk of disease and because vegetables can help prevent weight gain by lowering the energy density of a meal.
The purpose of this study was to investigate the effects of using herb and spice blends to create flavor variety in carrots as a model vegetable in a laboratory test meal.
We predict that children will consume more vegetables and that the energy density of the meal will be lower when a variety of seasoned carrots are presented in comparison to a single flavor.
A secondary goal of the study was to determine other influences that may predict children's liking and intake of seasoned vegetables, such as previous exposure, infant feeding practices, and genetic bitter sensitivity.
Study Overview
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16802
- The Pennsylvania State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Acceptance of test meal foods
- Generally healthy
Exclusion Criteria:
- Food allergies
- Medications (prescription or OTC) that can affect taste, smell or appetite
- Medical conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Variety
Children receive three servings of vegetables each prepared with a different herb and spice blend.
|
Vegetable flavor variety created with multiple herb and spice blends
|
No Intervention: No Variety - Control
Children receive three servings of vegetables each prepared with the same herb and spice blend.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chang in Vegetable Intake
Time Frame: Baseline and 1 week
|
Consumption is measured by pre- and post- weights of carrot offered in both the variety and no variety conditions
|
Baseline and 1 week
|
Change in Total Food Intake
Time Frame: Baseline and 1 week
|
Consumption is measured by pre- and post- weights of all meal items offered in both the variety and no variety conditions
|
Baseline and 1 week
|
Change in Meal Energy Density
Time Frame: Baseline and 1 week
|
Calculated from the total calories consumed divided by the grams of food eaten
|
Baseline and 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spice Intake Questionnaire
Time Frame: Baseline
|
A survey of maternally reported herb and spice consumption during pregnancy and breastfeeding as well as current home use
|
Baseline
|
Home Spice Checklist
Time Frame: Baseline
|
A comprehensive checklist of 34 herbs and spices for parents to fill out at home to evaluate children's overall herb and spice exposure
|
Baseline
|
Infant Feeding Practices
Time Frame: Baseline
|
A survey of maternally reported feeding practices, include breastfeeding, formula feeding, and introduction to solid foods.
|
Baseline
|
Liking of Broccoli with Herbs and Spices
Time Frame: Baseline
|
Liking is measured using a child friendly 5-pt hedonic scale; pilot data for future studies looking to apply this technique to green vegetables
|
Baseline
|
Liking of Carrots with Herb and Spice Blends
Time Frame: Baseline
|
Liking is measured using a child friendly 5-pt hedonic scale
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age
Time Frame: Baseline
|
Age of the participant on visit 1
|
Baseline
|
Height
Time Frame: Baseline
|
Height measured in cm on a stadiometer
|
Baseline
|
Weight
Time Frame: Baseline
|
Weight measured to the 0.1 pounds using a digital scale
|
Baseline
|
6-n-propylthiourcacil Sensitivity
Time Frame: Baseline
|
Children switch and spit a 56 umol solution of 6-n-propylthiouracil and are classified as tasters if it described as "bitter" or "yucky" and non-tasters if it's described as "nothing" or "like water".
|
Baseline
|
Body Mass Index
Time Frame: Baseline
|
Calculated from height and weight (kg/m^2)
|
Baseline
|
Children's Eating Behavior Questionnaire
Time Frame: Baseline
|
A validated parent-reported questionnaire on children's typical eating behaviors and attitudes toward foods
|
Baseline
|
Preschool Adjusted Liking Scale
Time Frame: Baseline
|
A questionnaire to assess children's liking of various common foods and daily activities.
|
Baseline
|
Family Demographics
Time Frame: Baseline
|
A parent-reported questionnaire
|
Baseline
|
Parental Feeding Practices
Time Frame: Baseline
|
A parent-reported questionnaire on typical feeding practices
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kathleen L Keller, Ph.D., The Pennsylvania State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2015
Primary Completion (Actual)
November 2, 2016
Study Completion (Actual)
November 2, 2016
Study Registration Dates
First Submitted
October 6, 2016
First Submitted That Met QC Criteria
February 1, 2017
First Posted (Estimate)
February 3, 2017
Study Record Updates
Last Update Posted (Actual)
April 5, 2022
Last Update Submitted That Met QC Criteria
April 4, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChildrensTasteStudy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric Obesity
-
Virginia Commonwealth UniversityActive, not recruitingObesity, PediatricUnited States
-
University of British ColumbiaThe Hospital for Sick Children; Canadian Institutes of Health Research (CIHR); Alberta Health services and other collaboratorsCompleted
-
Hasselt UniversityJessa HospitalCompletedObesity, Pediatric
-
Azienda Ospedaliera Universitaria Integrata VeronaNot yet recruitingObesity, Pediatric
-
University of British ColumbiaHeart and Stroke Foundation of Canada; Public Health Agency of Canada (PHAC); Childhood Obesity Foundation and other collaboratorsCompleted
-
Columbia UniversityCompletedVitamin D Deficiency | Obesity, Morbid | Obesity, Childhood | Obesity, PediatricUnited States
-
University Hospital, Clermont-FerrandAME2P Laboratory, Clermont Auvergne UniversityCompleted
-
Medical College of WisconsinWisconsin Department of Health and Family Services; Children's Health System...TerminatedPediatric Obesity | Pediatric OverweightUnited States
-
Kahramanmaras Sutcu Imam UniversityCompletedPediatric Obesity | Pediatric DentistryTurkey
-
Central Hospital, Nancy, FranceNot yet recruiting
Clinical Trials on Variety Intervention
-
The University of Tennessee, KnoxvilleCompletedCaloric IntakeUnited States
-
Instituto de Investigación Hospital Universitario...Alicorp S.A.A.Completed
-
University of MinnesotaRecruitingPhysical InactivityUnited States
-
Washington University School of MedicineMichigan State University; Project Peanut Butter, Ghana; College of Health Sciences...Completed
-
Instituto de Investigación Hospital Universitario...Go Fruselva, S.L.Completed
-
Penn State UniversityJenny Craig, Inc.Withdrawn
-
California Polytechnic State University-San Luis...Recruiting
-
Instituto de Investigación Hospital Universitario...Friobas Basilio S.L.Completed
-
The University of Tennessee, KnoxvilleNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); The... and other collaboratorsRecruiting