Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-29 @ 2:50 PM
Study NCT ID:
NCT01075932
Status:
COMPLETED
Last Update Posted:
2010-02-25
First Post:
2010-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Docosahexaenoic Acid (DHA)-Rich Fish Oil on Cerebral Haemodynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-24', 'studyFirstSubmitDate': '2010-02-24', 'studyFirstSubmitQcDate': '2010-02-24', 'lastUpdatePostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral blood flow', 'timeFrame': '12 weeks', 'description': 'Cerebral blood flow will be assessed using Near Infrared Spectroscopy while participants complete a series of cognitive tasks.'}], 'secondaryOutcomes': [{'measure': 'Cognitive function', 'timeFrame': '12 weeks', 'description': 'Cognitive function will be assessed using a series of tasks that evaluate working memory, attention and executive function.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cerebral blood flow', 'NIRS', 'n-3 PUFAs', 'fish oil', 'cognitive function'], 'conditions': ['Cerebral Blood Flow', 'Cognitive Function']}, 'referencesModule': {'references': [{'pmid': '22020134', 'type': 'DERIVED', 'citation': 'Jackson PA, Reay JL, Scholey AB, Kennedy DO. Docosahexaenoic acid-rich fish oil modulates the cerebral hemodynamic response to cognitive tasks in healthy young adults. Biol Psychol. 2012 Jan;89(1):183-90. doi: 10.1016/j.biopsycho.2011.10.006. Epub 2011 Oct 19.'}], 'seeAlsoLinks': [{'url': 'http://www.nutrition-neuroscience.co.uk/', 'label': 'Brain, Performance and Nutrition Research Centre, Northumbria University'}]}, 'descriptionModule': {'briefSummary': 'DHA has previously been shown to increase regional cerebral blood flow response to tactile stimulation in aged monkeys; modulation of cerebral blood flow in humans has yet to be demonstrated. Given that the brain relies on a constant supply of blood-borne metabolic substrates (e.g. glucose, oxygen), increasing regional cerebral blood flow may also have an impact on cognitive function. The current study aims to investigate the effects of two doses of DHA-rich fish oil on task-related cerebral hemodynamic response and cognitive performance in healthy adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', '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* consumes oily fish\n* takes omega-3 supplement\n* food allergies to treatment ingredients'}, 'identificationModule': {'nctId': 'NCT01075932', 'briefTitle': 'Effects of Docosahexaenoic Acid (DHA)-Rich Fish Oil on Cerebral Haemodynamics', 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': 'The Cognitive And Cerebral Hemodynamic Effects Of DHA-Rich Fish Oil: A Dose-Ranging Study', 'orgStudyIdInfo': {'id': '16N2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 g DHA-rich fish oil', 'description': '1 g DHA-rich fish oil containing 450 mg DHA + 90 mg EPA plus 1 g olive oil', 'interventionNames': ['Dietary Supplement: DHA-rich fish oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 g DHA-rich fish oil', 'description': '2 g DHA-rich fish oil containing 900 mg DHA + 180 mg EPA', 'interventionNames': ['Dietary Supplement: DHA-rich fish oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 g olive oil', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'DHA-rich fish oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Either 1 g or 2 g DHA-rich fish oil taken daily for 12 weeks. Participants in the 1 g group will also consume 1 g olive oil placebo capsules per day to maintain double blind.', 'armGroupLabels': ['1 g DHA-rich fish oil', '2 g DHA-rich fish oil']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 g placebo (olive oil) taken daily for 12 weeks', 'armGroupLabels': ['Placebo']}]}, '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'}, 'collaborators': [{'name': 'Ginsana SA', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Philippa Jackson', 'oldOrganization': 'Northumbria University'}}}}