Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT06892418
Status:
COMPLETED
Last Update Posted:
2025-04-02
First Post:
2025-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Ketoflex 12/3 Diet on Parkinson's Disease Symptoms: A Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2025-03-21', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in Motor Symptoms as Measured by the Unified Parkinson's Disease Rating Scale (UPDRS)", 'timeFrame': 'Baseline and 6 months', 'description': "The Unified Parkinson's Disease Rating Scale (UPDRS) is used to evaluate the severity of motor symptoms in Parkinson's disease. Scores range from 0 to 108 for the motor section, with higher scores indicating worse motor impairment."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease", 'Ketogenic Diet', 'Intermittent Fasting', 'Ketoflex 12/3', 'Neurodegenerative Disorders'], 'conditions': ['Parkinson's Disease', 'Parkinson']}, 'descriptionModule': {'briefSummary': "This study aims to investigate the effects of the Ketoflex 12/3 diet on motor and non-motor symptoms in patients with Parkinson's disease. Participants will follow the Ketoflex 12/3 dietary regimen, and their cognitive function, motor symptoms, sleep patterns, gastrointestinal health, and overall well-being will be assessed through standardized clinical scales. The study will help determine whether a plant-based ketogenic diet combined with intermittent fasting can have a beneficial impact on Parkinson's disease progression.", 'detailedDescription': "Parkinson's disease is a progressive neurodegenerative disorder characterized by motor and non-motor symptoms. Emerging evidence suggests that dietary interventions, particularly ketogenic diets and intermittent fasting, may play a role in neuroprotection and symptom management. This study investigates the effects of the Ketoflex 12/3 diet, a plant-based ketogenic dietary approach combined with intermittent fasting, on Parkinson's disease progression. Clinical assessments will include Unified Parkinson's Disease Rating Scale (UPDRS), Mini-Mental State Examination (MMSE), depression and anxiety scales, sleep quality assessments, and gastrointestinal health evaluations. The study aims to provide new insights into the potential benefits of metabolic-based nutritional interventions in Parkinson's disease patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with Parkinson's disease\n* Age between 40-85 years\n* Native Turkish speakers\n* Able to comply with the study protocol\n\nExclusion Criteria:\n\n* History of alcohol or substance dependence\n* Diagnosis of chronic renal failure\n* Presence of neuromuscular disorders\n* Having amalgam dental fillings and/or failure to remove them according to the SMART protocol\n* Severe vitamin deficiencies that have not been corrected prior to the study"}, 'identificationModule': {'nctId': 'NCT06892418', 'briefTitle': "Impact of Ketoflex 12/3 Diet on Parkinson's Disease Symptoms: A Clinical Study", 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': "A Clinical Study on the Effects of Ketoflex 12/3 Diet on Motor and Non-Motor Symptoms in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'PD23992'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketoflex 12/3 Diet Group', 'description': 'A plant-based ketogenic diet combined with intermittent fasting (12/3)', 'interventionNames': ['Behavioral: Ketoflex 12/3 Diet']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'Ketoflex 12/3 Diet', 'type': 'BEHAVIORAL', 'description': 'A plant-based ketogenic diet combined with intermittent fasting (12/3)', 'armGroupLabels': ['Ketoflex 12/3 Diet Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34214', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'İstanbul Medipol Üniversitesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'At this time, no final decision has been made regarding individual participant data (IPD) sharing. Future data-sharing plans will be considered in accordance with institutional policies, ethical guidelines, and publication requirements'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor.MD.PhD', 'investigatorFullName': 'Prof. Lutfu Hanoglu, MD', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}