- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Gelderland
-
Wageningen, Gelderland, Pays-Bas, 6703 HD
- Wageningen University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Vegetable and fruit intake
Délai: 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.
|
At the first 19 days of weaning (4-6 months of age)
|
|
Intake of the target Vegetables and fruits at 12 months of age.
Délai: 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.
|
|
Green beans and Apple intake at 23 months of age.
Délai: when infants are 23 months of age
|
Green beans and Apple intake at 23 months of age.
|
when infants are 23 months of age
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Vegetable and in fruit intake after the repeated exposure
Délai: After the repeated exposure period during the first 19 days of weaning
|
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.
|
After the repeated exposure period during the first 19 days of weaning
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Cees de Graaf, Prof., Wageningen University
Publications et liens utiles
Publications générales
- 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
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- NL28886.081.09
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .