- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02800538
The Effects of Intragastric Administration of Nutrients on Executive Control in Healthy Subjects.
The previous research by one of our members in the research team (H. Miller) suggests a possible influence of oral nutrients intake of certain fat or carbohydrates (glucose, fructose) on executive control. On the other hand, another previous study from our group (L. Van Oudenhove) suggests a subliminal influence of intragastric administration of fatty acids on subjective and neural responses to negative emotion induction. The purpose of this study therefore is to examine the effect of intragastric administration of certain fatty acids and carbohydrates on executive control in healthy volunteers.
Therefore one group of healthy volunteers are invited to the study. The participants will be randomly administered one of the three fatty acid emulsions or placebo via a nasogastric tube in each of the visits. After the exposure period, participants will use a computer to perform there different tasks to measure executive control. During each study visit, regular measurements of emotion, physical sensations, as well as blood glucose will be assessed. Furthermore, an electrocardiogram will be continuously recorded for the calculation of vagal function.
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
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-
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Leuven, Belgique, 3000
- University Hospitals Leuven, Campus Gasthuisberg
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- N = 26 These numbers are based on a power calculation for a repeated measures ANOVA with one within-subject factor using Gpower software version 3.1.7 (http://www.psycho.uni-duesseldorf.de/abteilungen/aap/gpower3), indicating that these sample sizes are needed to achieve 90% power to detect a medium-sized effect (f = 0.25).
- Men & women
- Age: >17 years
- 20 ≤ BMI ≤ 25
- Of good mental and physical health
Exclusion Criteria:
Participants with one or more of self-reported points below will be excluded:
History of, or current presence of:
- Psychiatric disorders (e.g., anxiety disorders, somatization disorder, eating disorders, depression, substance-related disorders alcohol abuse or dependence etc.)
- Abnormal eating behavior (including restraint and emotional eating)
- Abdominal/thoracic surgery
- Neurological, endocrine or digestive related disorders
- Head trauma with loss of consciousness
- Other serious medical conditions
- Use of any drugs, including cannabis, during the past 6 months
Current presence of:
- Pregnancy
- Medication use that affects the function of the gastrointestinal tract and/or affects the nervous system, psychotropics or painkillers
- A recent accident or surgery that has not fully recovered
Other
- Smoking
- Women not taking hormonal contraception
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Lauric acid
the nutrient that can be widely found in daily food.
|
Intragastric infusion of nutrient that can be widely found in daily food or placebo.
|
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Expérimental: Palmitic acid
the nutrient that can be widely found in daily food.
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Intragastric infusion of nutrient that can be widely found in daily food or placebo.
|
|
Expérimental: Capric acid
the nutrient that can be widely found in daily food.
|
Intragastric infusion of nutrient that can be widely found in daily food or placebo.
|
|
Comparateur placebo: Saline
physiological salt water
|
Intragastric infusion of nutrient that can be widely found in daily food or placebo.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
trial making task
Délai: 60 min after intervention
|
Participants will be required to connect a set of 25 numbered dots in numerical order as fast as possible while still maintaining accuracy.
|
60 min after intervention
|
|
digital span task
Délai: 60 min after intervention
|
Participants will be presented with a series of single-digit numbers and required to remember them.
After the series has been presented the participants will need to indicate the numbers presented.
|
60 min after intervention
|
|
memory task
Délai: 60 min after intervention
|
A list of 15 words that are matched for frequency, concreteness, and imagery will be presented to the participant via a computer monitor at the rate of one every 2 sec.
Afterwards they will be given 60 sec to write down as many words as they are able to recall from the list.
Accuracy and errors will be recorded.
|
60 min after intervention
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- S56123
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