Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-14 @ 9:32 AM
Study NCT ID:
NCT02245035
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2014-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dairy Intake and Brain Health in Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-19', 'studyFirstSubmitDate': '2014-09-15', 'studyFirstSubmitQcDate': '2014-09-17', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral glutathione (GSH) levels measured by magnetic resonance spectroscopy (MRS)', 'timeFrame': 'Baseline'}, {'measure': 'Dietary dairy food intake measured using 7-day diet recording', 'timeFrame': '1 week, prior to MRS scan'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glutathione', 'Dairy consumption', 'Brain', 'Humans'], 'conditions': ['Aged Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn if dairy food consumption may help brain health in aging by protecting nerve cells from oxidative damage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy elderly individuals with an age range of 60-85 years.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and females between 60-85 years of age.\n2. Good general health with no concomitant diseases, which would be expected to interfere with the study\n3. BMI range 20-35 kg/m2\n\nExclusion Criteria:\n\n1. Presence of any central neurological disease with the potential to impair cognition(e.g., brain tumor, stroke, epilepsy, motor neuron disease, multiple sclerosis, Alzheimer disease, Parkinson's disease) or prior major head trauma with loss of consciousness\n2. Presence of an active unstable and life-threatening systemic illness (e.g., cancer)\n3. Presence of major psychiatric disorder within the past 3 years including depression, anxiety, and alcohol (over 3 drinks per day or total of 18 per week) or drug abuse (DSM-IV criteria; Geriatric Depression Score\\>6)\n4. Presence of diabetes mellitus (defined as a clinical diagnosis or use of an anti-diabetic agent) and metabolic syndrome\n5. Use of psychoactive and investigational medications\n6. Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia. All subjects subjects will receive a structural MRI as part of this study. Individuals with evidence of infection, infarction, neoplasm or other lesions will be excluded. Individuals found to have abnormalities in their structural MRI will be referred to their primary physician for further evaluation and management.\n7. Pregnancy\n8. Special diet regimens such as lactose free or vegan"}, 'identificationModule': {'nctId': 'NCT02245035', 'briefTitle': 'Dairy Intake and Brain Health in Aging', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Dairy Intake and Brain Health in Aging', 'orgStudyIdInfo': {'id': '12884'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low dairy intake', 'description': '1 serving/day or less of dairy food characterized at enrollment using 24 hr dietary recall'}, {'label': 'Moderate Dairy Intake', 'description': '1-2 servings/day of dairy food characterized at enrollment using 24 hr dietary recall'}, {'label': 'Recommended Dairy Intake', 'description': 'Greater than 3 servings/day of dairy food characterized at enrollment using 24 hr dietary recall'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'In-Young Choi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Dairy Council', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'In-Young Choi, Ph.D.', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}