Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-01-05 @ 6:06 AM
Study NCT ID:
NCT02017418
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2013-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of a Zeaxanthin Intervention on Visuomotor Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065146', 'term': 'Zeaxanthins'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2013-12-16', 'studyFirstSubmitQcDate': '2013-12-16', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Macular pigment optical density', 'timeFrame': 'one year', 'description': 'Increases in the amount of macular pigment measured in optical density units'}], 'secondaryOutcomes': [{'measure': 'fixed reaction time', 'timeFrame': 'one year', 'description': 'reaction time to a stimulus fixed in space'}, {'measure': 'variable reaction time', 'timeFrame': '12-months', 'description': 'reaction time to a stimulus with a position that varies in space'}, {'measure': 'coincidence anticipation', 'timeFrame': '12-months', 'description': 'button press when a light stimulus of varying speeds reaches a specific point in a linear light array'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['zeaxanthin', 'visual function', 'reaction time', 'processing speed'], 'conditions': ['Behavior and Behavior Mechanisms']}, 'descriptionModule': {'briefSummary': 'This study was designed to test whether two zeaxanthin formulations (supplements containing different nutritional compounds with zeaxanthin and omega fatty acids being the primary ingredients of interest) influenced visual motor function. Visual motor function refers to the processing speed of the visual system and how individuals respond behavioral to visual stimuli (e.g., reaction time).', 'detailedDescription': 'This study was designed to test whether two zeaxanthin formulations (supplements containing different nutritional compounds with zeaxanthin and omega fatty acids being the primary ingredients of interest) influenced visual motor function. Visual motor function refers to the processing speed of the visual system and how individuals respond behavioral to visual stimuli (e.g., reaction time).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: ≥18 and ≤ 40 years\n* BMI: ≥ 20 and ≤ 30 kg/m2\n* No anticipated changes in dieting habits (as relevant to the intake of xanthophylls and fats/oils).\n* No anticipated surgical procedures.\n* Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements.\n* Corrected visual acuity (ETDRS): better than 20/60 in the eye selected for the study\n\nExclusion Criteria:\n\n* Smokers\n* Current or history of relevant ocular diseases (such as AMD) or other conditions e.g., lipid disorders.\n* Inability to reliably perform macular pigment optical density measurements by "Heterochromatic Flicker Photometry" or any of the other ophthalmic tests of the study.\n* Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls (e.g., digestive disorders: inflammatory bowel disease, ulcerative colitis, Crohn\'s, irritable bowel, etc. or lipid disorders including conditions such as hypercholesterolemia)\n* Current use of xanthophyll containing supplements or use of xanthophyll containing supplements in the past 6 months (but excluding multivitamins containing lutein or zeaxanthin at low potency).\n* Participation in any other study during last 1 month before study initiation.\n* Known hypersensitivity or allergy to xanthophylls.\n* Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes. These include diabetes medication and statins or any other drug/supplement to modulate cholesterol or fat digestion/absorption.'}, 'identificationModule': {'nctId': 'NCT02017418', 'briefTitle': 'The Effects of a Zeaxanthin Intervention on Visuomotor Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Georgia'}, 'officialTitle': 'The Effects of a Zeaxanthin Intervention on Visuomotor Function', 'orgStudyIdInfo': {'id': '2012-10531'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'zeaxanthin', 'description': 'placebo zeaxanthin', 'interventionNames': ['Dietary Supplement: zeaxanthin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'combinatory supplement', 'description': 'placebo combinatory supplement', 'interventionNames': ['Dietary Supplement: combinatory supplement']}], 'interventions': [{'name': 'zeaxanthin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'softgel', 'armGroupLabels': ['zeaxanthin']}, {'name': 'combinatory supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['zeaxanthin + lutein + DHA'], 'description': 'softgel', 'armGroupLabels': ['combinatory supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30602', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Department of Psychology, UGA', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}], 'overallOfficials': [{'name': 'Billy R Hammond, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Georgia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Georgia', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZeaVision, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Principal Investigator', 'investigatorFullName': 'Billy R. Hammond', 'investigatorAffiliation': 'University of Georgia'}}}}