Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT06040905
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Causal Effect of Coenzyme Q10 Nutrition and Cognitive Dysfunction in the Metabolic Storm (Hyperglycemia and Sarcopenia) and Brain-derived Neurotrophic Factor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024989', 'term': 'coenzyme Q10'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2023-09-04', 'studyFirstSubmitQcDate': '2023-09-10', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ATP level', 'timeFrame': '12 weeks', 'description': 'ATP level will measured by ATP determination kit.'}, {'measure': 'Citrate synthase level', 'timeFrame': '12 weeks', 'description': 'Citrate synthase level will measured by Citrate Synthase Assay Kit.'}, {'measure': "Quality of Life in Alzheimer's Disease Measure (QOL-AD)", 'timeFrame': '12 weeks', 'description': 'The QOL-AD score is the sum of all 13 items. Higher scores mean participants are more satisfied with their quality of life.'}, {'measure': 'Geriatric Depression Scale (GDS)', 'timeFrame': '12 weeks', 'description': 'The GDS score is the sum of all 15 items. Higher scores indicate a tendency for participants to feel depressed.'}], 'primaryOutcomes': [{'measure': 'Fasting glucose', 'timeFrame': '12 weeks', 'description': 'Fasting glucose will measured by an automated chemistry analyzer.'}, {'measure': 'HbA1C', 'timeFrame': '12 weeks', 'description': 'HbA1C will measured by an automated glycated hemoglobin analyzer.'}, {'measure': 'Insulin', 'timeFrame': '12 weeks', 'description': 'Insulin will measured by chemiluminescence assay.'}, {'measure': 'C-peptide', 'timeFrame': '12 weeks', 'description': 'C-peptide will measured by chemiluminescence assay.'}, {'measure': 'Brain-derived neurotrophic factor (BDNF)', 'timeFrame': '12 weeks', 'description': 'Sreum BDNF level will measured by huamn BDNF ELISA kit.'}, {'measure': 'Irisin', 'timeFrame': '12 weeks', 'description': 'Measured by huamn Irisin ELISA kit.'}, {'measure': 'Myostatin', 'timeFrame': '12 weeks', 'description': 'Measured by human myostatin ELISA kit.'}], 'secondaryOutcomes': [{'measure': 'Malondialdehyde (MDA) level', 'timeFrame': '12 weeks', 'description': 'MDA will measured by thiobarbituric acid reacting substance.'}, {'measure': 'Advanced Glycation End Products (AGEs) level', 'timeFrame': '12 weeks', 'description': 'AGE level will measured by competitive enzyme-linked immunosorbent assay.'}, {'measure': 'Total antioxidant capacity', 'timeFrame': '12 weeks', 'description': 'Total antioxidant capacity will measured by a Trolox equivalent antioxidant capacity assay.'}, {'measure': 'Mini-Mental State Examination (MMSE) score', 'timeFrame': '12 weeks', 'description': 'The maximum score for the MMSE is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.'}, {'measure': 'Muscle mass', 'timeFrame': '12 weeks', 'description': 'Muscle mass will measured by (Bioelectrical impedance analysis) BIA menchine.'}, {'measure': 'Hand grip', 'timeFrame': '12 weeks', 'description': 'Hand grip strength will be measured with a grip dynamometer.'}, {'measure': 'Short Physical Performance Battery (SPPB) measurement', 'timeFrame': '12 weeks', 'description': 'SPPB is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults. A lower score means low physical fitness.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment', 'Alzheimer Disease', 'Hyperglycemia', 'Pre-sarcopenia']}, 'descriptionModule': {'briefSummary': "The aim of the study is to investigate the effect of coenzyme Q10 supplementation (150 mg/b.i.d, 300 mg/d, 12 weeks) on coenzyme Q10, glucose parameters, BDNF, myokines, and cognitive function in mild cognitive impairment (MCI) and Alzheimer's disease (AD) patients who combined with hyperglycemia but without sarcopenia, or with hyperglycemia and pre-sarcopenia.", 'detailedDescription': "Alzheimer's disease (AD) is an aging-related disease and is considered to be a type 3 diabetes. Brain-derived neurotrophic factor (BDNF) is a potential therapeutic biomarker for AD. Studies have found that antioxidant supplementation could elevate the level of BDNF. Coenzyme Q10 is an antioxidant nutrient that participates in energy synthesis in mitochondria. Studies have shown that coenzyme Q10 has the potential to regulate blood glucose. However, there are few clinical studies to examine the effects of coenzyme Q10 supplementation on glucose and muscular metabolism and BDNF status in AD. This study will conduct an intervention study to understand the effect of coenzyme Q10 on BDNF and metabolic conditions (hyperglycemia and pre-sarcopenia) in patients with mild cognitive impairment (MCI) and AD. The study will be designed as a randomized, double-blind, cross-over, placebo-controlled study. To investigate the effect of coenzyme Q10 supplementation (150 mg/b.i.d, 300 mg/d, 12 weeks) on coenzyme Q10, glucose parameters, BDNF, myokines, and cognitive function in MCI and AD patients who combined with hyperglycemia but without sarcopenia, or with hyperglycemia and pre-sarcopenia. During the study, demographic data, mini-mental state examination, anthropometric measurements, dietary records, nutritional and muscle function assessment, quality of life, and depression assessment will be collected. Blood specimens will be also collected before and after the intervention; then the levels of coenzyme Q10, BDNF, oxidative stress, antioxidant capacity, myokines, and mitochondrial function will be analyzed. The study hopes to clarify the cause effects of coenzyme Q10 supplementation on the regulation of glucose and muscle metabolism, and cognitive function in this prospective clinical study. The results of this study will provide a reference for aging nutrition and health care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of mild cognitive impairment (MCI).\n* Clinical diagnosis of Alzheimer's Disease.\n* MCI and AD patients with hyperglycemia ( Fasting glucose \\>=100 mg/dL).\n* MCI and AD patients with pre-sarcopenia (low calf circumference, low hand grip, or low muscle endurance).\n* Must be able to swallow tablets.\n\nExclusion Criteria:\n\n* Cancer patients.\n* Severe heart, lung, liver, and kidney diseases.\n* Severe disability or aphasia.\n* Malnutrition (body weight changes \\> 5% within one month).\n* Using coenzyme Q10 supplements.\n* Warfarin therapy."}, 'identificationModule': {'nctId': 'NCT06040905', 'briefTitle': 'Causal Effect of Coenzyme Q10 Nutrition and Cognitive Dysfunction in the Metabolic Storm (Hyperglycemia and Sarcopenia) and Brain-derived Neurotrophic Factor', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Causal Effect of Coenzyme Q10 Nutrition and Cognitive Dysfunction in the Metabolic Storm (Hyperglycemia and Sarcopenia) and Brain-derived Neurotrophic Factor', 'orgStudyIdInfo': {'id': 'CS1-22182'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coenzyme Q10', 'description': 'Coenzyme Q10 300 mg/day (150 mg/b.i.d.)', 'interventionNames': ['Dietary Supplement: Coenzyme Q10']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (dextrin)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Coenzyme Q10', 'type': 'DIETARY_SUPPLEMENT', 'description': '300 mg/day (150mg/b.i.d)', 'armGroupLabels': ['Coenzyme Q10']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Starch, dextrin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ping-Ting Lin, Ph.D.', 'role': 'CONTACT', 'email': 'apt810@csmu.edu.tw', 'phone': '+886-4-24730022', 'phoneExt': '12187'}], 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Ping-Ting Lin, Ph.D.', 'role': 'CONTACT', 'email': 'apt810@csmu.edu.tw', 'phone': '+886-4-24730022', 'phoneExt': '12187'}], 'overallOfficials': [{'name': 'Ping-Ting Lin, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chung Shan Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ping-Ting Lin', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}