Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-13 @ 7:46 AM
Study NCT ID:
NCT01075958
Status:
COMPLETED
Last Update Posted:
2011-09-02
First Post:
2010-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Polyunsaturated Fatty Acids (PUFA) Status and Cognitive Function in Healthy Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005222', 'term': 'Mental Fatigue'}], 'ancestors': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'philippa.jackson@northumbria.ac.uk', 'phone': '+44 191 204 8818', 'title': 'Dr Philippa Jackson', 'organization': 'Northumbria University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected only on the day of testing.', 'description': 'The testing day comprised a single 90 minute session.', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Participants', 'description': 'Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.', 'otherNumAtRisk': 283, 'otherNumAffected': 0, 'seriousNumAtRisk': 283, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Simple Reaction Time (Attention)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'All eligible participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '287.7', 'spread': '2.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single visit', 'description': "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.", 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Only those participants for whom a venous blood sample was obtained (N=239) were entered into the analysis. A further 20 participants were excluded on the basis that their BMI exceeded 30, and could not be considered 'healthy individuals'."}, {'type': 'SECONDARY', 'title': 'Depression, Anxiety and Stress Scale (DASS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'All eligible participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.45', 'spread': '16.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single visit-90 minutes', 'description': '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).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Choice Reaction Time (Attention)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'All eligible participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '412.79', 'spread': '3.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single visit', 'description': '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.', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Four Choice Reaction Time (Attention)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'All eligible participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '499.52', 'spread': '5.84', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single visit', 'description': "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.", 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Numeric Working Memory (Working Memory)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'All eligible participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.57', 'spread': '0.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single visit', 'unitOfMeasure': 'percent of correct responses', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Alphabetic Working Memory (Working Memory)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'All eligible participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.5', 'spread': '0.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single visit', 'description': '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.', 'unitOfMeasure': 'percent of correct responses', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Corsi Blocks Span (Spatial Working Memory)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'All eligible participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.90', 'spread': '0.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single visit', 'description': '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.', 'unitOfMeasure': 'Blocks remembered in sequence', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '3-back Task (Working Memory)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'All eligible participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.89', 'spread': '1.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single visit', 'description': '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.', 'unitOfMeasure': 'percent of correct responses', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Immediate Word Recall (Episodic Memory)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'All eligible participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.21', 'spread': '0.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single visit', 'description': '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.', 'unitOfMeasure': 'Number of words recalled', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Delayed Word Recall (Episodic Memory)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'All eligible participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.73', 'spread': '0.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single visit', 'description': 'The participant was again given 60 seconds to write down as many of the words presented previously as possible.', 'unitOfMeasure': 'Number of words recalled', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Word Recognition (Episodic Memory)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'All eligible participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.35', 'spread': '0.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single visit', 'description': "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.", 'unitOfMeasure': 'percent of correct responses', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Participants', 'description': 'Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '283'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '239'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Blood sample could not be obtained', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}]}]}], 'recruitmentDetails': 'Recruitment took place on the Northumbria University campus via posted adverts and email messages sent using the university distribution lists. Recruitment took place in 2 waves; the first taking place between July 31 - November 8 2007, and the second between March 26 - September 9 2008.', 'preAssignmentDetails': 'Participants from whom a venous blood sample could not be obtained were not entered into the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Participants', 'description': 'Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '283', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.47', 'spread': '3.95', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '187', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '283', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 283}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-02', 'studyFirstSubmitDate': '2010-02-24', 'resultsFirstSubmitDate': '2011-02-23', 'studyFirstSubmitQcDate': '2010-02-24', 'lastUpdatePostDateStruct': {'date': '2011-09-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-02', 'studyFirstPostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Simple Reaction Time (Attention)', 'timeFrame': 'Single visit', 'description': "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."}, {'measure': 'Choice Reaction Time (Attention)', 'timeFrame': 'Single visit', 'description': '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.'}, {'measure': 'Four Choice Reaction Time (Attention)', 'timeFrame': 'Single visit', 'description': "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."}, {'measure': 'Numeric Working Memory (Working Memory)', 'timeFrame': 'Single visit'}, {'measure': 'Alphabetic Working Memory (Working Memory)', 'timeFrame': 'Single visit', 'description': '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.'}, {'measure': 'Corsi Blocks Span (Spatial Working Memory)', 'timeFrame': 'Single visit', 'description': '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.'}, {'measure': '3-back Task (Working Memory)', 'timeFrame': 'Single visit', 'description': '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.'}, {'measure': 'Immediate Word Recall (Episodic Memory)', 'timeFrame': 'Single visit', 'description': '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.'}, {'measure': 'Delayed Word Recall (Episodic Memory)', 'timeFrame': 'Single visit', 'description': 'The participant was again given 60 seconds to write down as many of the words presented previously as possible.'}, {'measure': 'Word Recognition (Episodic Memory)', 'timeFrame': 'Single visit', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Depression, Anxiety and Stress Scale (DASS)', 'timeFrame': 'Single visit-90 minutes', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['n-3 PUFAs', 'Fish oil', 'Cognitive function', 'Healthy young adults'], 'conditions': ['Attention', 'Memory', 'Mood', 'Mental Fatigue']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nutrition-neuroscience.co.uk/', 'label': 'Brain, Performance and Nutrition Research Centre, Northumbria University'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The sample will be drawn from a student and professional population in the Newcastle upon Tyne area in the UK', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/Female\n* 18-35 years\n* Healthy\n* No herbal supplements/prescription medications (excl. contraceptive pill)\n* Non smoker\n* Native English speaker\n\nExclusion Criteria:\n\n* BMI ≥ 30'}, 'identificationModule': {'nctId': 'NCT01075958', 'briefTitle': 'Polyunsaturated Fatty Acids (PUFA) Status and Cognitive Function in Healthy Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': 'The Relationship Between Serum PUFAs and Cognitive Function in Healthy Young Adults', 'orgStudyIdInfo': {'id': '16N3'}}, 'contactsLocationsModule': {'locations': [{'zip': 'NE1 8ST', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'facility': 'Northumbria University', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Philippa A Jackson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northumbria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Philippa Jackson', 'oldOrganization': 'Northumbria University'}}}}