Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-27 @ 12:44 PM
Study NCT ID:
NCT03236259
Status:
COMPLETED
Last Update Posted:
2021-02-25
First Post:
2017-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Berry Extract Administration on Cognitive Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2017-07-31', 'lastUpdatePostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognition', 'timeFrame': '6 months', 'description': 'test attention with STROOP'}, {'measure': 'Cognition', 'timeFrame': '6 months', 'description': "Test concentration with 'cijferdoorstreep test'"}, {'measure': 'Cognition', 'timeFrame': '6 months', 'description': 'Test psychomotor speed with grooved pegboard'}], 'secondaryOutcomes': [{'measure': 'vascular structure', 'timeFrame': '6 months', 'description': 'measure vascular structure with ultrasound.'}, {'measure': 'Mood', 'timeFrame': '6 months', 'description': 'Test mood with visual analogue mood scale. 8 emotions are scored on a 1-10 scale.'}, {'measure': 'Blood pressure', 'timeFrame': '6 months'}, {'measure': 'Liver function', 'timeFrame': '6 months', 'description': 'analysis of alkaline phosphatase, alanine aminotransferase, aspartaat aminotransferase, bilirubine, gamma-glutamyltransferase to determine liver function.'}, {'measure': 'flavo-enzyme', 'timeFrame': '6 months', 'description': 'monoamine oxidase B analysis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Impairment', 'Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of daily supplementation of Brainport for a period of 6 months on cognitive health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy individuals\n* Age between 40 and 60 years\n* BMI 25 - 35 kg/m2\n\nExclusion Criteria:\n\n* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat). Dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and /or laboratory assessments that might limit participation in or completion of the study protocol.\n* Diabetes\n* Use of medication that might have influence on endpoints (hypertension medication)\n* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to the study\n* Use of antibiotics in the 30 days prior to the start of the study\n* Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine\n* Pregnancy, lactation\n* Abuse of products (\\> 20 alcoholic consumptions per week and drugs)\n* Smoking\n* Weight gain or loss (\\> 3 kg in previous 3 months)\n* High physical activity (\\>4.5 hours of running/week)\n* History of any side effects towards intake of berries'}, 'identificationModule': {'nctId': 'NCT03236259', 'briefTitle': 'The Effect of Berry Extract Administration on Cognitive Health', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effect of Berry Extract Administration on Cognitive Health', 'orgStudyIdInfo': {'id': 'Brainport-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Brainport high dose', 'interventionNames': ['Dietary Supplement: Brainport high dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brainport low dose', 'interventionNames': ['Dietary Supplement: Brainport low dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Maltodextrin', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Brainport high dose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'berry extract, high dose. Daily ingestion of capsule', 'armGroupLabels': ['Brainport high dose']}, {'name': 'Brainport low dose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Berry extract, low dose. Daily ingestion of capsule', 'armGroupLabels': ['Brainport low dose']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Maltodextrin. Daily ingestion of capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioActor B.V.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}