Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-03-14 @ 11:44 PM
Study NCT ID:
NCT02751866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-01
First Post:
2016-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Intervention in Cognitive Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'There is no blind in the dietary intervention given that participants are aware of the nature of the foods they consume. However, each dietary approach is described as healthy. In the berry supplementation studies, there is double blinding using berry fruit and placebo powders that are packaged with a code.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention with carbohydrate restriction designed to produce adaptation to ketone metabolism OR intervention with berry fruit powder supplementation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2016-04-21', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin resistance', 'timeFrame': 'Eight or 12 weeks after enrollment', 'description': 'HOMA-IR will be derived from fasting glucose and insulin'}, {'measure': 'Cognitive function', 'timeFrame': 'Eight or 12 weeks after enrollment', 'description': 'Performances on examiner-adminstered instruments assessing memory function'}], 'secondaryOutcomes': [{'measure': 'Long term glucose concentration', 'timeFrame': 'Eight or 12 weeks after enrollment', 'description': 'Glycated hemoglobin value'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overweight, Obesity and Other Hyperalimentation (E65-E68)']}, 'descriptionModule': {'briefSummary': 'Nutritional intervention in overweight middle aged individuals with subjective memory complaints.', 'detailedDescription': 'Late-onset AD develops over many years during a preclinical period in which neuropathological changes accumulate before dementia is evident. Deposition of amyloid-beta (Aβ) in the brain is the earliest recognized biomarker of AD pathology, and, demographically, Aβ accumulation begins to accelerate at age 50, a period when the incidence of metabolic disturbance increases as well. Hyperinsulinemia associated with insulin receptor resistance has been associated with AD pathololgy, and metabolic disturbance in mid-life increases risk for subsequent dementia. There are indications that subjective memory complaints can be an early indicator of developing neuropathology and may be the first manifestation of future dementia. This research involves intervention studies in different samples of individuals from this population to investigate the extent to which berry fruit supplementation and ketone metabolism might improve cognitive performance in association with enhancement of metabolic function and related factors. The ultimate goal of this research is to develop interventional approaches that might be applied with at-risk individuals in the preclinical period of dementia to forestall or prevent progression of neurocognitive decline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* overweight; subjective memory complaints\n\nExclusion Criteria:\n\n* diabetes; liver or kidney disease; age-related memory disorder; neurologic or psychiatric condition; substance abuse'}, 'identificationModule': {'nctId': 'NCT02751866', 'briefTitle': 'Early Intervention in Cognitive Aging', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Early Intervention in Cognitive Aging', 'orgStudyIdInfo': {'id': '2015-1256'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active supplement, low carbohydrate', 'description': 'Whole fruit berry powder, low carbohydrate diet', 'interventionNames': ['Dietary Supplement: Berry fruit powder OR nutritional ketosis']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo, Control', 'description': 'placebo powder, higher carbohydrate diet', 'interventionNames': ['Dietary Supplement: Placebo powder OR higher carbohydrate']}], 'interventions': [{'name': 'Berry fruit powder OR nutritional ketosis', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily supplementation with berry fruit powder OR carbohydrate restriction to achieve nutritional ketosis', 'armGroupLabels': ['Active supplement, low carbohydrate']}, {'name': 'Placebo powder OR higher carbohydrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily supplementation with placebo powder OR higher carbohydrate intake', 'armGroupLabels': ['Placebo, Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45267-0559', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dept of Psychiatry & Behavioral Neuroscience, UC Academic Health Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Robert Krikorian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati Academic Health Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert Krikorian', 'investigatorAffiliation': 'University of Cincinnati'}}}}