- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03043118
Children's Taste Study to Increase Vegetable Intake in Preschoolers (CTS)
4. april 2022 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
48
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Pennsylvania
-
University Park, Pennsylvania, Forente stater, 16802
- The Pennsylvania State University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
3 år til 5 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
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Ingen inngripen: No Variety - Control
Children receive three servings of vegetables each prepared with the same herb and spice blend.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Chang in Vegetable Intake
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and 1 week
|
Calculated from the total calories consumed divided by the grams of food eaten
|
Baseline and 1 week
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Spice Intake Questionnaire
Tidsramme: Baseline
|
A survey of maternally reported herb and spice consumption during pregnancy and breastfeeding as well as current home use
|
Baseline
|
|
Home Spice Checklist
Tidsramme: 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
Tidsramme: Baseline
|
A survey of maternally reported feeding practices, include breastfeeding, formula feeding, and introduction to solid foods.
|
Baseline
|
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Liking of Broccoli with Herbs and Spices
Tidsramme: 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
Tidsramme: Baseline
|
Liking is measured using a child friendly 5-pt hedonic scale
|
Baseline
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Age
Tidsramme: Baseline
|
Age of the participant on visit 1
|
Baseline
|
|
Height
Tidsramme: Baseline
|
Height measured in cm on a stadiometer
|
Baseline
|
|
Weight
Tidsramme: Baseline
|
Weight measured to the 0.1 pounds using a digital scale
|
Baseline
|
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6-n-propylthiourcacil Sensitivity
Tidsramme: 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
Tidsramme: Baseline
|
Calculated from height and weight (kg/m^2)
|
Baseline
|
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Children's Eating Behavior Questionnaire
Tidsramme: Baseline
|
A validated parent-reported questionnaire on children's typical eating behaviors and attitudes toward foods
|
Baseline
|
|
Preschool Adjusted Liking Scale
Tidsramme: Baseline
|
A questionnaire to assess children's liking of various common foods and daily activities.
|
Baseline
|
|
Family Demographics
Tidsramme: Baseline
|
A parent-reported questionnaire
|
Baseline
|
|
Parental Feeding Practices
Tidsramme: Baseline
|
A parent-reported questionnaire on typical feeding practices
|
Baseline
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Kathleen L Keller, Ph.D., The Pennsylvania State University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2015
Primær fullføring (Faktiske)
2. november 2016
Studiet fullført (Faktiske)
2. november 2016
Datoer for studieregistrering
Først innsendt
6. oktober 2016
Først innsendt som oppfylte QC-kriteriene
1. februar 2017
Først lagt ut (Anslag)
3. februar 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. april 2022
Sist bekreftet
1. april 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ChildrensTasteStudy
Plan for individuelle deltakerdata (IPD)
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NEI
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