- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01075958
Polyunsaturated Fatty Acids (PUFA) Status and Cognitive Function in Healthy Young Adults
2 agosto 2011 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Osservativo
Iscrizione (Effettivo)
283
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Tyne and Wear
-
Newcastle upon Tyne, Tyne and Wear, Regno Unito, NE1 8ST
- Northumbria University
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 35 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
The sample will be drawn from a student and professional population in the Newcastle upon Tyne area in the UK
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Simple Reaction Time (Attention)
Lasso di tempo: Single visit
|
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.
|
Single visit
|
|
Choice Reaction Time (Attention)
Lasso di tempo: Single visit
|
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.
|
Single visit
|
|
Four Choice Reaction Time (Attention)
Lasso di tempo: Single visit
|
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.
|
Single visit
|
|
Numeric Working Memory (Working Memory)
Lasso di tempo: Single visit
|
Single visit
|
|
|
Alphabetic Working Memory (Working Memory)
Lasso di tempo: Single visit
|
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.
|
Single visit
|
|
Corsi Blocks Span (Spatial Working Memory)
Lasso di tempo: Single visit
|
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.
|
Single visit
|
|
3-back Task (Working Memory)
Lasso di tempo: Single visit
|
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.
|
Single visit
|
|
Immediate Word Recall (Episodic Memory)
Lasso di tempo: Single visit
|
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.
|
Single visit
|
|
Delayed Word Recall (Episodic Memory)
Lasso di tempo: Single visit
|
The participant was again given 60 seconds to write down as many of the words presented previously as possible.
|
Single visit
|
|
Word Recognition (Episodic Memory)
Lasso di tempo: Single visit
|
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.
|
Single visit
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Depression, Anxiety and Stress Scale (DASS)
Lasso di tempo: Single visit-90 minutes
|
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).
|
Single visit-90 minutes
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 luglio 2007
Completamento primario (Effettivo)
1 settembre 2008
Completamento dello studio (Effettivo)
1 settembre 2008
Date di iscrizione allo studio
Primo inviato
24 febbraio 2010
Primo inviato che soddisfa i criteri di controllo qualità
24 febbraio 2010
Primo Inserito (Stima)
25 febbraio 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
2 settembre 2011
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 agosto 2011
Ultimo verificato
1 agosto 2011
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 16N3
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 .
Prove cliniche su Stanchezza mentale
-
King's College LondonSouth London and Maudsley NHS Foundation TrustIscrizione su invitoDetenzione in base al Mental Health ActRegno Unito
-
Yonsei UniversityCompletatoInfermieri che lavorano presso il Community Mental Health Welfare CenterCorea, Repubblica di