Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-02-22 @ 4:14 AM
Study NCT ID:
NCT02379169
Status:
UNKNOWN
Last Update Posted:
2015-03-04
First Post:
2014-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Sea Buckthorn Oil and Lutein on Eye Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014975', 'term': 'Lutein'}], 'ancestors': [{'id': 'D024341', 'term': 'Xanthophylls'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-26', 'studyFirstSubmitDate': '2014-11-07', 'studyFirstSubmitQcDate': '2015-02-26', 'lastUpdatePostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in serum markers of sea buckthorn oil and lutein intake', 'timeFrame': '0 months, 6 months', 'description': 'analysis from serum samples'}], 'primaryOutcomes': [{'measure': 'Change in macular pigment optical density from baseline to 6 mo', 'timeFrame': '0 mo, 3 mo, 6 mo', 'description': 'measurement of macular pigment optical density'}], 'secondaryOutcomes': [{'measure': 'Change in symptoms of dry eye from baseline to 6 mo', 'timeFrame': '0 months, 3 months, 6 months', 'description': 'questionnaires, symptom logbook'}, {'measure': 'Change in serum lipids (Triglycerides, HDL-cholesterol, LDL-cholesterol, total cholesterol) from baseline to 6 mo', 'timeFrame': '0 months, 6 months', 'description': 'analysis from serum samples'}, {'measure': 'Change in serum markers of inflammation (hs-CRP) from baseline to 6 mo', 'timeFrame': '0 months, 6 months', 'description': 'analysis from serum samples'}, {'measure': 'Change in circulating aminotransferases (ALAT, ASAT) from baseline to 6 mo', 'timeFrame': '0 months, 6 months', 'description': 'analysis from plasma samples'}, {'measure': 'Change in contrast sensitivity from baseline to 6 mo', 'timeFrame': '0 mo, 3 mo, 6 mo', 'description': 'analysis of contrast sensitivity'}, {'measure': 'Change in vision aquity from baseline to 6 mo', 'timeFrame': '0 mo, 3 mo, 6 mo', 'description': 'ETDRS chart'}, {'measure': 'Change in vision functioning from baseline to 6 mo', 'timeFrame': '0 mo, 3 mo, 6 mo', 'description': 'questionnaire'}, {'measure': 'Change in tear film osmolarity from baseline to 6 mo', 'timeFrame': '0 mo, 3 mo, 6 mo', 'description': 'measurement of tear film osmolarity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['macular pigment optical density, age related macular degeneration, dry eye, vision'], 'conditions': ['Risk Factors for Age Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'Low macular pigment optical density has been associated with increased risk of age-related macular degeneration, an important cause of vision problems in the elderly population. Dry eye is multifactorial disease of tears and the ocular surface associated with symptoms of dryness, grittiness, burning and redness of eyes. The risk of dry eye increases with age. The aim is to investigate the effects of sea buckthorn oil complemented with lutein on eye health, specifically on the macula.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- macular pigment optical density equal to or less than 0,40 OD\n\nExclusion Criteria:\n\n* diabetic retinopathy\n* macular changes associated with high blood pressure\n* signs of macular degeneration: classes 2, 3 and 4 according to the Rotterdam study (Mol Vis 2012: 657-74)\n* severe eye diseases, exluding cataract. The intervention will begina after surgery and recovery from cataract'}, 'identificationModule': {'nctId': 'NCT02379169', 'acronym': 'SBEYE', 'briefTitle': 'Effects of Sea Buckthorn Oil and Lutein on Eye Health', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'orgStudyIdInfo': {'id': 'SBEYE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sea buckthorn & lutein', 'description': 'Sea buckthorn oil complemented with lutein. Dose: 2 g/day as capsules taken twice/day for 6 months', 'interventionNames': ['Dietary Supplement: Sea buckthorn oil & lutein']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Triglycerides of medium-chain fatty acids. Dose: 2 g/day as capsules taken twice/day for 6 months', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Sea buckthorn oil & lutein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Standardised sea buckthorn seed and pulp oil complemented with lutein', 'armGroupLabels': ['Sea buckthorn & lutein']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Triglycerides of medium chain fatty acids', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Aromtech Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}