Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT03592251
Status:
COMPLETED
Last Update Posted:
2019-01-24
First Post:
2018-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Memory Consolidation in Healthy Adults
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': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-23', 'studyFirstSubmitDate': '2018-05-29', 'studyFirstSubmitQcDate': '2018-07-09', 'lastUpdatePostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Computerised Location Learning task', 'timeFrame': '26 months', 'description': 'Delayed recall accuracy'}, {'measure': 'Verbal Learning task', 'timeFrame': '26 months', 'description': 'Delayed recall accuracy'}], 'secondaryOutcomes': [{'measure': 'Computerised Location Learning task', 'timeFrame': '26 months', 'description': 'Learning index'}, {'measure': 'Verbal Learning task', 'timeFrame': '26 months', 'description': 'Learning index'}, {'measure': 'Peg and Ball/Tower of London task', 'timeFrame': 'pre, Mid and post dose measures', 'description': 'Planning time (ms)'}, {'measure': 'Peg and Ball/Tower of London task', 'timeFrame': 'pre, Mid and post dose measures', 'description': 'Completion time (ms)'}, {'measure': 'Peg and Ball/Tower of London task', 'timeFrame': 'pre, Mid and post dose measures', 'description': 'Errors (number)'}, {'measure': 'Simple reaction time task', 'timeFrame': '26 months', 'description': 'reaction time speed from a simple reaction task'}, {'measure': 'Digit vigilance task', 'timeFrame': '26 months', 'description': 'accuracy (%)'}, {'measure': 'Digit vigilance task', 'timeFrame': '26 months', 'description': 'Reaction time (ms)'}, {'measure': 'Subjective Alertness', 'timeFrame': '26 months', 'description': 'Subjective ratings of alertness upon waking on a visual analogue scale (0-100 with 100 denoting the most alert the participant has ever felt in their life)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Memory Consolidation']}, 'referencesModule': {'references': [{'pmid': '34113957', 'type': 'DERIVED', 'citation': 'Patan MJ, Kennedy DO, Husberg C, Hustvedt SO, Calder PC, Khan J, Forster J, Jackson PA. Supplementation with oil rich in eicosapentaenoic acid, but not in docosahexaenoic acid, improves global cognitive function in healthy, young adults: results from randomized controlled trials. Am J Clin Nutr. 2021 Sep 1;114(3):914-924. doi: 10.1093/ajcn/nqab174.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3 polyunsaturated fatty acid dietary supplements on overnight verbal and visual memory consolidation as well as morning alertness before and after 26 weeks of supplementation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 25 to 49 years inclusive\n* Males and females\n* Self-report of good health\n\nExclusion Criteria:\n\n* English is not first language (some of the cognitive tasks have only been validated in native English speakers)\n* Habitual consumption of oily fish exceeds one fish meal per week\n* Habitual consumption of n-3 dietary supplements in the previous 6 months\n* Habitual use of dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total; some supplements that do not impact upon cognitive function e.g. garlic, protein, calcium are allowed. Please check with the research team if you are unsure)\n* Are a smoker or consume any nicotine replacement products (e.g. chewing gum, e-cigarettes)?\n* Food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff\n* Pregnant, trying to get pregnant or breast feeding\n* Body Mass Index outside of the range 18-35 kg/m2\n* High blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)\n* Currently taking blood pressure medication\n* Currently taking blood thinning medication (e.g. aspirin, warfarin, heparin)\n* Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)\n* Have frequent migraines that require medication (more than or equal to 1 per month)\n* History or current diagnosis of drug/alcohol abuse\n* History of kidney or liver disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalcaemia), that are likely to interfere with metabolism/absorption/secretion of the product under investigation\n* History of neurological or psychiatric illness (excluding depressive illness and anxiety)\n* History of head trauma\n* Sleep disturbances and/or are taking sleep aid medication\n* Blood disorders (e.g. anaemia, haemophilia, thrombocytosis)\n* Diagnosis of type I or type II diabetes\n* Heart disorder, or vascular illness\n* Current diagnosis of depression and/or anxiety\n* Over- or under-active thyroid\n* Chronic gastrointestinal problems (e.g. Inflammatory Bowel Disease, Irritable Bowel Syndrome, celiac disease)\n* Any known active infections\n* Diagnosed with or may be at risk of having syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus\n* Current or past breast cancer diagnosis and/or a mastectomy\n* Health condition that would prevent fulfilment of the study requirements\n* Currently participating in or in the past 4 weeks participated in other clinical or nutrition intervention studies'}, 'identificationModule': {'nctId': 'NCT03592251', 'briefTitle': "26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Memory Consolidation in Healthy Adults", 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': "Efficacy Evaluation of 26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Memory Consolidation in Healthy Adults", 'orgStudyIdInfo': {'id': '44N6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Olive oil Placebo', 'description': '3 x 1 g capsules daily Placebo: olive oil', 'interventionNames': ['Dietary Supplement: EPA-rich', 'Dietary Supplement: DHA-rich']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EPA-rich', 'description': '3 x 1 g capsules daily containing a SMEDDS formulation of an EPA-enriched oil totalling 900 mg EPA and 360 mg of DHA', 'interventionNames': ['Dietary Supplement: Olive Oil Placebo', 'Dietary Supplement: DHA-rich']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DHA-Rich', 'description': '3 x 1 g capsules daily containing a SMEDDS formulation of an DHA-enriched oil totalling 900 mg DHA and 270 mg of EPA', 'interventionNames': ['Dietary Supplement: Olive Oil Placebo', 'Dietary Supplement: EPA-rich']}], 'interventions': [{'name': 'Olive Oil Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '6 months placebo supplementation', 'armGroupLabels': ['DHA-Rich', 'EPA-rich']}, {'name': 'EPA-rich', 'type': 'DIETARY_SUPPLEMENT', 'description': '6 months placebo supplementation', 'armGroupLabels': ['DHA-Rich', 'Olive oil Placebo']}, {'name': 'DHA-rich', 'type': 'DIETARY_SUPPLEMENT', 'description': '6 months placebo supplementation', 'armGroupLabels': ['EPA-rich', 'Olive oil 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}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'collaborators': [{'name': 'BASF', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}