- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01075958
Polyunsaturated Fatty Acids (PUFA) Status and Cognitive Function in Healthy Young Adults
2. august 2011 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
283
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Tyne and Wear
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Newcastle upon Tyne, Tyne and Wear, Det Forenede Kongerige, NE1 8ST
- Northumbria University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 35 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The sample will be drawn from a student and professional population in the Newcastle upon Tyne area in the UK
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Simple Reaction Time (Attention)
Tidsramme: 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
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Choice Reaction Time (Attention)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Single visit
|
Single visit
|
|
Alphabetic Working Memory (Working Memory)
Tidsramme: 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)
Tidsramme: 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.
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Single visit
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3-back Task (Working Memory)
Tidsramme: 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)
Tidsramme: 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.
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Single visit
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Delayed Word Recall (Episodic Memory)
Tidsramme: 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)
Tidsramme: 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.
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Single visit
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Depression, Anxiety and Stress Scale (DASS)
Tidsramme: 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).
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Single visit-90 minutes
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2007
Primær færdiggørelse (Faktiske)
1. september 2008
Studieafslutning (Faktiske)
1. september 2008
Datoer for studieregistrering
Først indsendt
24. februar 2010
Først indsendt, der opfyldte QC-kriterier
24. februar 2010
Først opslået (Skøn)
25. februar 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. september 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. august 2011
Sidst verificeret
1. august 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 16N3
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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