Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT01104194
Status:
COMPLETED
Last Update Posted:
2011-07-11
First Post:
2010-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Fish-oil on Mood and Cognitive Functions of Healthy Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-08', 'studyFirstSubmitDate': '2010-04-12', 'studyFirstSubmitQcDate': '2010-04-14', 'lastUpdatePostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognition', 'timeFrame': '4 weeks', 'description': 'Battery of test measuring emotional and neutral information processing. Largest effect expected on Decision Making Test (cf. Antypa et al., 2009) and Emotion Recognition Test.'}, {'measure': 'Heart Rate Variability', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Mood states', 'timeFrame': '4 weeks', 'description': 'Fatigue, Anger, Tension, Anxiety, Vigor (Profile of Mood States, self-report measure).\n\nDepressive symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression', 'cognition', 'heart rate variability', 'omega-3 fatty acids', 'Depression (in remission) (vulnerability to depression)'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The investigators recently found a positive effect of omega-3 supplements on cognitive function in healthy individuals after 4 weeks (J of Psychopharmacology 2009, 23: 831-840). The investigators hypothesize that 4 weeks consumption of omega-3 supplements in previously depressed individuals will positively affect their cognitive functions.\n\nSecondly, low Heart Rate Variability (HRV) is a risk factor for cardiovascular disease. Some studies have found low HRV in patients with depression. No studies have investigated the effects of omega-3 fatty acid supplements on Heart Rate Variability in individuals with a history of depression. The investigators will test the hypotheses that omega-3 supplements lead to an improvement of heart rate variability indices in healthy volunteers with a history of depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dutch-speaking men and women\n* Normal weight (BMI between 18 and 27).\n* Regular diets, not containing fish more than once a week.\n* History of depression (at least one major depressive episode in the past).\n\nExclusion Criteria:\n\n* Currently more than mildly depressed (BDI-II-NL score higher than 19, or score on the suicidality item of this scale higher than 1).\n* Current or past psychosis\n* Current substance abuse or past substance dependence\n* Smoking or current use of soft drugs (current = month prior to study till completion)\n* Any hard drug use (lifetime)\n* More than 3 alcoholic consumptions/day\n\nParticipants will be asked to keep their dietary habits constant throughout the study.'}, 'identificationModule': {'nctId': 'NCT01104194', 'briefTitle': 'Effects of Fish-oil on Mood and Cognitive Functions of Healthy Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'The Effects of Omega-3 Fatty Acids Dietary Supplements (Fish-oil) on Mood and Cognitive Functions of Healthy Individuals', 'orgStudyIdInfo': {'id': 'P07.063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fish-oil', 'interventionNames': ['Dietary Supplement: omega-3 fatty acids supplements (fish oil)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Olive oil capsules, identical in appearance to fish oil capsules', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'omega-3 fatty acids supplements (fish oil)', 'type': 'DIETARY_SUPPLEMENT', 'description': '1.74g eicosapentaenoic acid (EPA) and 0.25g docosahexaenoic acid (DHA)', 'armGroupLabels': ['Fish-oil']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'softgel capsules (identical in appearance to fish oil capsules) containing olive oil. 3 capsules/day, 4 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333 AK', 'city': 'Leiden', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Leiden University', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof AJW Van der Does', 'oldOrganization': 'Leiden University'}}}}