- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01075958
Polyunsaturated Fatty Acids (PUFA) Status and Cognitive Function in Healthy Young Adults
2 août 2011 mis à jour par: Northumbria University
The Relationship Between Serum PUFAs and Cognitive Function in Healthy Young Adults
To date, the relationship between omega-3 polyunsaturated fatty acids (n-3 PUFAs) in cognitively intact individuals has only been examined in a limited number of studies; it is at present unknown whether supplementation with n-3 PUFAs can improve cognitive function and mood in this population.
Further to this, it still remains to be established whether a relationship exists between peripheral fatty acid status-reflective of dietary n-3 PUFA intake-and cognitive function in this population.
The current study therefore aims to address this issue by exploring the relationship between serum PUFAs and specific cognitive functions in a sample of healthy adults.
To this end, participants will complete a range of cognitive tasks evaluating performance across the domains of attention, memory and executive function.
Self-report mood assessments will be included as secondary measures.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Observationnel
Inscription (Réel)
283
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Tyne and Wear
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Newcastle upon Tyne, Tyne and Wear, Royaume-Uni, NE1 8ST
- Northumbria University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 35 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
The sample will be drawn from a student and professional population in the Newcastle upon Tyne area in the UK
La description
Inclusion Criteria:
- Male/Female
- 18-35 years
- Healthy
- No herbal supplements/prescription medications (excl. contraceptive pill)
- Non smoker
- Native English speaker
Exclusion Criteria:
- BMI ≥ 30
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Simple Reaction Time (Attention)
Délai: Single visit
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The participant was instructed to press the 'space bar' on the laptop keyboard as quickly as possible every time an upwards pointing arrow appeared on screen.
Fifty stimuli were presented with an inter-stimulus duration that varied randomly between 1 and 3.5 seconds.
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Single visit
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Choice Reaction Time (Attention)
Délai: Single visit
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An arrow appeared on the screen pointing to the left or to the right.
Participants responded with a left or right key press corresponding to the direction of the arrow.
There was a randomly varying inter-stimulus interval of between 1 and 3 seconds for a total of fifty stimuli.
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Single visit
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Four Choice Reaction Time (Attention)
Délai: Single visit
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A visual representation of the four direction arrow keys of a standard keyboard was presented on screen.
The arrows 'lit up' at random on screen until the corresponding key press was made.
In all, each arrow was the target stimulus 12 times, forming a total of 48 stimuli for this task in all.
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Single visit
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Numeric Working Memory (Working Memory)
Délai: Single visit
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Single visit
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Alphabetic Working Memory (Working Memory)
Délai: Single visit
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Five random letters (A-Z) were presented sequentially for the participant to hold in memory.
This was followed by a series of 30 probe digits (15 targets and 15 distractors) for each of which the participant indicated whether or not it had been in the original series by a simple key press.
The task consisted of 3 separate trials.
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Single visit
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Corsi Blocks Span (Spatial Working Memory)
Délai: Single visit
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In this task nine identical blue squares appeared on screen in non-overlapping random positions.
A set number of blocks changed colour from blue to red in a randomly generated sequence.
Participants were instructed to repeat the sequence by clicking on the blocks using the mouse and cursor.
The task was repeated five times at each level of difficulty.
The sequence span increased from 4, until the participant could no longer correctly recall the sequence, resulting in a span measure of nonverbal working memory, calculated by averaging the level of the last five correctly completed trials.
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Single visit
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3-back Task (Working Memory)
Délai: Single visit
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A continuous string of letters (upper and lower case; inter-stimulus interval of 2.5 seconds) was presented; 45 letters in total with 15 target pairs.
For each stimulus, participants were instructed to indicate whether this was the same letter that appeared three letters before.
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Single visit
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Immediate Word Recall (Episodic Memory)
Délai: Single visit
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A unique set of fifteen words is presented.
Words were selected at random from a large bank of words derived from the MRC Psycholinguistic Database matched for word length, frequency, familiarity and concreteness.
Stimulus duration was one second, as was the inter-stimulus duration.
Following word presentation, the participant was allowed 60 seconds to write down as many of the words as possible.
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Single visit
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Delayed Word Recall (Episodic Memory)
Délai: Single visit
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The participant was again given 60 seconds to write down as many of the words presented previously as possible.
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Single visit
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Word Recognition (Episodic Memory)
Délai: Single visit
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The original 15 words plus 15 distractor words were presented one at a time in a random order.
For each word the participant indicated whether or not it was included in the original list of words by pressing appropriate 'yes' and 'no' keys as quickly as possible.
Stimuli remained on screen until an appropriate response had been made.
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Single visit
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Depression, Anxiety and Stress Scale (DASS)
Délai: Single visit-90 minutes
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The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress.
Each of the three DASS scales contains 14 items.
Subjects are asked to use 4-point (0-3) severity/frequency scales to rate the extent to which they have experienced each state over the past week.
Scores for Depression, Anxiety and Stress (0-42) are calculated by summing the scores for the relevant items, with higher scores indicating higher incidence of negative emotional symptoms.
A total score can be derived by adding scores from each of the subscales (0-126).
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Single visit-90 minutes
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juillet 2007
Achèvement primaire (Réel)
1 septembre 2008
Achèvement de l'étude (Réel)
1 septembre 2008
Dates d'inscription aux études
Première soumission
24 février 2010
Première soumission répondant aux critères de contrôle qualité
24 février 2010
Première publication (Estimation)
25 février 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
2 septembre 2011
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 août 2011
Dernière vérification
1 août 2011
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 16N3
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