Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-02-20 @ 10:12 PM
Study NCT ID:
NCT01672359
Status:
COMPLETED
Last Update Posted:
2014-08-06
First Post:
2012-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Whole Foods Supplementation on Cognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002794', 'term': 'Choline'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D009861', 'term': 'Onium Compounds'}]}}, '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': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-04', 'studyFirstSubmitDate': '2012-08-20', 'studyFirstSubmitQcDate': '2012-08-23', 'lastUpdatePostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Measures', 'timeFrame': '6 months', 'description': 'The measures included the MMSE, the Stroop Color and Word Test (SCWT), the Trail Making Test Parts A and B (TMT-A, TMT-B), the Controlled Oral Word Association test (COWA), the Digit Symbol subtest of the Wechsler Adult Intelligence Scale, Third Edition (WAIS-III), and the Hopkins Verbal Learning Test-Revised (HVLT-R)'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Measures', 'timeFrame': '6 months', 'description': 'Quality of Well-Being Scale (QWBS) Medical Outcomes Study Short Form 36 (SF 36) Beck Depression Inventory (BDI) Beck Anxiety Inventory (BAI)'}, {'measure': 'Immune Function Markers', 'timeFrame': '6 months', 'description': 'interleukin \\[IL\\]-2, IL-4, IL-6, IL-8, IL-10, IL-1α, IL-1β, interferon \\[IFN\\]-γ, tumor necrosis factor \\[TNF\\]-α, monocyte chemotactic protein \\[MCP\\]-1, vascular endothelial growth factor \\[VEGF\\], and epidermal growth factor \\[EGF\\]'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cognitive functioning', 'immune function', 'cytokines', 'growth factors', 'quality of life', 'dietary supplementation', 'Ginkgo biloba', 'Improvement of cognitive function'], 'conditions': ['Sub-optimal Cognitive Function', 'Sub-optimal Immune Function']}, 'referencesModule': {'references': [{'pmid': '24495355', 'type': 'DERIVED', 'citation': 'Lewis JE, Melillo AB, Tiozzo E, Chen L, Leonard S, Howell M, Diaz J, Gonzalez K, Woolger JM, Konefal J, Paterson E, Barnes D. A double-blind, randomized clinical trial of dietary supplementation on cognitive and immune functioning in healthy older adults. BMC Complement Altern Med. 2014 Feb 4;14:43. doi: 10.1186/1472-6882-14-43.'}]}, 'descriptionModule': {'briefSummary': 'A six-month study which investigated the effect of Ginkgo Synergy® and Choline or OPC Synergy® and Catalyn® on cognitive and immune function markers and quality of life among healthy older adults with no history of significant cognitive deficits'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 years of age and older\n* English speaking\n* Not living in a skilled or intermediate care level nursing facility\n* No use of dietary supplements for cognitive functioning two weeks before enrolling in the study and during the length of the trial\n* A Mini-Mental State Exam (MMSE) score ≥ 23\n\nExclusion Criteria:\n\n* A cognitive deficit greater than that indicated according to the MMSE score\n* A clinical diagnosis of AD and/or related disorders\n* A psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence\n* Bleeding disorders\n* Aphasia or sensory, motor, and/or visual disturbances that would have interfered with psychometric tests\n* Gastrointestinal disorders causing impaired absorption of the study supplements\n* Insulin-dependent diabetes\n* Major conditions such as cardiovascular, pulmonary, renal, thyroid, hepatic, gastrointestinal, or seizure\n* Hematologic or oncologic disorders treated with chemotherapy in the previous two years\n* Active chemotherapy or radiation treatment for cancer\n* Current cigarette smoking\n* More than three major medical or psychiatric hospitalizations in the past year\n* Diagnosis of a terminal illness\n* A T score \\> 70 on the Global Severity Index of the Brief Symptoms Inventory (BSI)\n* A score ≥ 29 on the Beck Depression Inventory-II (BDI) (15)\n* Prescription and OTC sympathomimetic amines and antihistamines within 2 days of an assessment visit\n* Cognition enhancing drugs consumption such as Donepezil, Rivastigmine, Galantamine, and Tacrine\n* Coumadin, tricyclic antidepressants, antipsychotics, and anticonvulsants\n* Cognition-enhancing supplements, herbs, or antioxidants that could not be stopped during the trial\n* Participating in a concurrent trial for drugs, supplements, or treatment that affects behavior or cognitive function'}, 'identificationModule': {'nctId': 'NCT01672359', 'briefTitle': 'Evaluating Whole Foods Supplementation on Cognition', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'The Effect of Whole-Food Dietary Supplementation on Cognitive and Immune Functioning and Quality of Life in Healthy Older Adults', 'orgStudyIdInfo': {'id': '20090985'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ginkgo Synergy® and Choline', 'description': 'Ginkgo Synergy® (120 mg/day Ginkgo biloba leaf with 80 mg/day Ginkgo biloba whole extract combined with 40 mg/day Grape Seed extract) and Choline (700 mg choline/day)', 'interventionNames': ['Dietary Supplement: Ginkgo Synergy® and Choline']}, {'type': 'EXPERIMENTAL', 'label': 'OPC Synergy® and Catalyn', 'description': 'OPC Synergy® (100 mg/day of Grape Seed extract with 50 mg/day Green Tea extract (60% catechins)) and Catalyn® (1,248 IU/day of Vitamin D, 4,800 IU/day of Vitamin A, combined with vitamin C, thiamine, riboflavin, and vitamin B6)', 'interventionNames': ['Dietary Supplement: OPC Synergy® and Catalyn']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'cellulose pills to simulate actual products', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Ginkgo Synergy® and Choline', 'type': 'DIETARY_SUPPLEMENT', 'description': '3 tablets 2 times per day with breakfast and dinner over 6 months', 'armGroupLabels': ['Ginkgo Synergy® and Choline']}, {'name': 'OPC Synergy® and Catalyn', 'type': 'DIETARY_SUPPLEMENT', 'description': '3 tablets 2 times per day with breakfast and dinner over 6 months', 'armGroupLabels': ['OPC Synergy® and Catalyn']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Building', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'John Lewis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Standard Process Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'John E. Lewis', 'investigatorAffiliation': 'University of Miami'}}}}