NCT03043118

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

October 6, 2016

Last Update Submit

April 4, 2022

Conditions

Keywords

Eating BehaviorsPreschoolVegetable Intake

Outcome Measures

Primary Outcomes (3)

  • Chang in Vegetable Intake

    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

    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

    Calculated from the total calories consumed divided by the grams of food eaten

    Baseline and 1 week

Secondary Outcomes (5)

  • Spice Intake Questionnaire

    Baseline

  • Home Spice Checklist

    Baseline

  • Infant Feeding Practices

    Baseline

  • Liking of Broccoli with Herbs and Spices

    Baseline

  • Liking of Carrots with Herb and Spice Blends

    Baseline

Other Outcomes (9)

  • Age

    Baseline

  • Height

    Baseline

  • Weight

    Baseline

  • +6 more other outcomes

Study Arms (2)

Variety

EXPERIMENTAL

Children receive three servings of vegetables each prepared with a different herb and spice blend.

Other: Variety Intervention

No Variety - Control

NO INTERVENTION

Children receive three servings of vegetables each prepared with the same herb and spice blend.

Interventions

Vegetable flavor variety created with multiple herb and spice blends

Variety

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Acceptance of test meal foods
  • Generally healthy

You may not qualify if:

  • Food allergies
  • Medications (prescription or OTC) that can affect taste, smell or appetite
  • Medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Pediatric ObesityFeeding Behavior

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Kathleen L Keller, Ph.D.

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 6, 2016

First Posted

February 3, 2017

Study Start

February 1, 2015

Primary Completion

November 2, 2016

Study Completion

November 2, 2016

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations