- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01075958
Polyunsaturated Fatty Acids (PUFA) Status and Cognitive Function in Healthy Young Adults
2 de agosto de 2011 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
283
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Tyne and Wear
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Newcastle upon Tyne, Tyne and Wear, Reino Unido, NE1 8ST
- Northumbria University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 35 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
The sample will be drawn from a student and professional population in the Newcastle upon Tyne area in the UK
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Simple Reaction Time (Attention)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: Single visit
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Single visit
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Alphabetic Working Memory (Working Memory)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Depression, Anxiety and Stress Scale (DASS)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de julho de 2007
Conclusão Primária (Real)
1 de setembro de 2008
Conclusão do estudo (Real)
1 de setembro de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
24 de fevereiro de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de fevereiro de 2010
Primeira postagem (Estimativa)
25 de fevereiro de 2010
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
2 de setembro de 2011
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de agosto de 2011
Última verificação
1 de agosto de 2011
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 16N3
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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