- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01858337
Mum Can I Have Vegetables Again? Development of Vegetable Preferences (VaVo)
Mum Can I Have Vegetables Again? Development of Vegetable Preferences.
- Rationale: Despite the health benefits, children's consumption of vegetables is below the recommendations. Most human food preferences are learned through mere exposure, imitation, and conditioning principles. During the last years, it has become clear that the development of food preferences starts very early in life. Furthermore, preferences that are learned early in life, are relatively stable and may track into adulthood. However, it is unclear how vegetable preferences develop from infancy until young childhood. In order to influence vegetable consumption, it is essential to study the opportunities to develop a preference for vegetable products early in childhood.
- Objective: The aim of this study is to investigate the effect of repeated exposure to vegetables compared to repeated exposure to fruit during weaning on short and long term vegetable and fruit intake. Furthermore, the stability of the learned fruit or vegetable preferences and the later food preferences are measured (i.e. vegetable, fruits, sweets).
- Study design:
In this longitudinal study we will measure the development of preferences for a particular vegetable or fruit type within 4 to 6 months old subjects, during a 19 day exposure period to fruit or vegetables (of which 9 days exposure to the target fruit or vegetable) and 6 months after this exposure period. In addition, we compare the food preferences (fruit, vegetable, sweet foods in general), after 6 months, between infants who were weaned with a variety of fruits and infants who were weaned with a variety of vegetables.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Gelderland
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Wageningen, Gelderland, Olanda, 6703 HD
- Wageningen University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Infants between 4 and 6 months of age that are apparently healthy are invited to participate in the study. The parents have to give permission for themselves and for their infant to participate by signing an informed consent. By signing the informed consent the parents also agree to participate in the study for 2 years.
Exclusion Criteria:
- The parents will not sign the informed consent
- The parents have already started weaning their child
- The infant has a food allergy or intolerance
- The child has medical problems that influences with eating or food digestion. (e.g. schisis, problems with the bowls)
- The child has a known cognitive or physical developmental problem, which influences how the child's reaction or facial expressions.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: green beans group,
1 of the 2 vegetable groups.
The infants were weaned only with vegetables.
With green beans every other day and another vegetable on the days in between.
|
Infants were weaned with vegetable purees for the first 18 days of weaning.
One vegetable type per day.
With green beans every other day.
|
Sperimentale: Artichoke group
1 of the 2 vegetable groups.
The infants were weaned only with vegetables.
With Artichoke every other day and another vegetable on the days in between
|
Infants were weaned with vegetable purees for the first 18 days of weaning.
One vegetable type per day.
With artichoke every other day.
|
Comparatore attivo: Apple group
1 of the 2 fruit groups.
The infants were weaned only with fruits.
With Apple every other day and other fruits on the days in between
|
Infants were weaned with fruit purees for the first 18 days of weaning.
One fruit type per day.
With apple every other day.
|
Comparatore attivo: Plums group
1 of the 2 fruit groups.
The infants were weaned only with vegetables.
With Plums every other day and other fruits on the days in between
|
Infants were weaned with fruit purees for the first 18 days of weaning.
One fruit type per day.
With Plums every other day.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in Vegetable and fruit intake
Lasso di tempo: At the first 19 days of weaning (4-6 months of age)
|
Change in Vegetable and fruit intake from before to after the repeated exposure to it.
Measured at day 1 and 2 and day 17 and 18 at the intervention.
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At the first 19 days of weaning (4-6 months of age)
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Intake of the target Vegetables and fruits at 12 months of age.
Lasso di tempo: 6 months after the intervention. Mean age 12 months.
|
Vegetable and fruit intake at 12 months of age.
Measured in the lab.
Fruit group received apple, plum and green beans at 3 different days
|
6 months after the intervention. Mean age 12 months.
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Green beans and Apple intake at 23 months of age.
Lasso di tempo: when infants are 23 months of age
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Green beans and Apple intake at 23 months of age.
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when infants are 23 months of age
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Vegetable and in fruit intake after the repeated exposure
Lasso di tempo: After the repeated exposure period during the first 19 days of weaning
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Difference in vegetable intake between vegetable and fruit groups and in fruit intake between the vegetable and fruit groups.
Vegetable intake is measured on day 17 and 18 in the vegetable groups and in the fruit groups at day 19 (when fruit groups gets the first vegetable.
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After the repeated exposure period during the first 19 days of weaning
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Cees de Graaf, Prof., Wageningen University
Pubblicazioni e link utili
Pubblicazioni generali
- Barends, C.d.V., J; Mojet, J & de Graaf, C, Effects of repeated exposure to either vegetables or fruits on infant's vegetable and fruit acceptance at the beginning of weaning. Food quality and preference, 29 , 157-165, 2013
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- NL28886.081.09
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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