Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT06376266
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Intervention Effectiveness of Branched-chain Amino Acids(BCAA) Combined With Medium-chain Fatty Acid(MCFA) Products in Sarcopenia Among Middle-aged and Elderly Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the scale of sarcopenia', 'timeFrame': 'Baseline, 8 weeks', 'description': 'muscle mass: this study utilizes BIA or DXA to measure the ASMI (kg/ht\\^2)'}, {'measure': 'the scale of sarcopenia', 'timeFrame': 'Baseline, 8 weeks', 'description': 'muscle strength: Use a handgrip dynamometer to measure the dominant hand grip strength (kgw) of the participants. Take the maximum value of three measurements, with a one-minute interval between each measurement.'}, {'measure': 'the scale of sarcopenia', 'timeFrame': 'Baseline, 8 weeks', 'description': 'physical performance: During testing, participants are required to cross their arms across their chests and record the time (seconds) taken to perform five consecutive sit-to-stand movements and their walking speed (m/s) over a distance of 6 meters.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcopenia', 'branched-chain amino acids(BCAA)', 'medium-chain fatty acid(MCFA)'], 'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': "Taiwan entered an aging society in 2018 and is expected to transition into a super-aged society by 2025. With the increasing elderly population, age-related diseases pose urgent challenges to modern society. According to the Ministry of Health and Welfare's National Health Statistics in 2018, the prevalence of sarcopenia in Taiwan among individuals aged 65 and older is 23.6% for males and 18.6% for females. Sarcopenia, characterized by the loss of skeletal muscle mass due to aging, coupled with decreased muscle strength and/or reduced physical performance, poses a significant risk for disability, decreased quality of life, and increased mortality.\n\nExisting research indicates that appropriate nutrition and exercise can slow the onset of sarcopenia and even increase muscle mass to reverse its effects. This study is an interventional clinical trial recruiting middle-aged and elderly patients with sarcopenia or pre-sarcopenia. The intervention involves a combination of branched-chain amino acids and medium-chain triglyceride products, and the study aims to assess the effectiveness of this intervention for sarcopenia in middle-aged and elderly individuals.", 'detailedDescription': "Project Rationale:\n\nTaiwan entered an aging society in 2018 and is expected to transition into a super-aged society by 2025. With the increasing elderly population, age-related diseases pose urgent challenges to modern society. According to the Ministry of Health and Welfare's National Health Statistics in 2018, the prevalence of sarcopenia in Taiwan among individuals aged 65 and older is 23.6% for males and 18.6% for females. Sarcopenia, characterized by the loss of skeletal muscle mass due to aging, coupled with decreased muscle strength and/or reduced physical performance, poses a significant risk for disability, decreased quality of life, and increased mortality.\n\nExisting research indicates that appropriate nutrition and exercise can slow the onset of sarcopenia and even increase muscle mass to reverse its effects. This study is an interventional clinical trial recruiting middle-aged and elderly patients with sarcopenia or pre-sarcopenia. The intervention involves a combination of branched-chain amino acids and medium-chain triglyceride products, and the study aims to assess the effectiveness of this intervention for sarcopenia in middle-aged and elderly individuals.\n\nProject Objectives:\n\nEvaluate the effectiveness of branched-chain amino acids combined with medium-chain triglyceride products as an intervention for sarcopenia in middle-aged and elderly individuals.\n\nMethods:\n\nThe study cohort will be recruited from National Taiwan University Hospital, targeting individuals aged 50 and above with sarcopenia or pre-sarcopenia. Randomized double-blind allocation will divide participants into intervention and control groups, with each group recruiting 40 subjects (80 participants in total). The intervention group will receive a daily supplement of branched-chain amino acids combined with medium-chain triglycerides, while the control group will be given maltodextrin of the same packaging and quantity as a placebo.\n\nThe study will assess various physiological parameters and functional fitness items, conducting the same tests after an 8-week period to evaluate the effectiveness of branched-chain amino acids combined with medium-chain triglyceride products for sarcopenia intervention in middle-aged and elderly individuals.\n\nExpected Outcomes:\n\nConfirmation of the efficacy of nutritional supplements primarily consisting of branched-chain amino acids and medium-chain triglycerides in intervening in muscle loss and promoting daily life functionality in middle-aged and elderly individuals.\n\nEnhanced understanding of the etiology, diagnosis, and assessment methods of sarcopenia among participating staff.\n\nThe study anticipates no patent or other commercial interests. If there are any research developments, they will be owned by National Taiwan University Hospital, with potential applications such as publishing academic papers or technology transfer in the future."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 50 years\n* Diagnosis of sarcopenia or pre-sarcopenia\n\nExclusion Criteria:\n\n* Lack of willingness to participate\n* Complete dependence on activities of daily living\n* Diagnosis of cancer\n* Physician-determined life expectancy of less than two years\n* Deemed incapable of undergoing assessment by a physician or clinical assessor'}, 'identificationModule': {'nctId': 'NCT06376266', 'briefTitle': 'Assessment of the Intervention Effectiveness of Branched-chain Amino Acids(BCAA) Combined With Medium-chain Fatty Acid(MCFA) Products in Sarcopenia Among Middle-aged and Elderly Individuals', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Aged and Elderly Individuals', 'orgStudyIdInfo': {'id': '202305083RSC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'receive a daily supplement of branched-chain amino acids combined with medium-chain triglycerides', 'description': 'receive a daily supplement of branched-chain amino acids combined with medium-chain triglycerides', 'interventionNames': ['Combination Product: nutritional supplements']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'receive a daily supplement of maltodextrin of the same packaging and quantity', 'description': 'receive a daily supplement of maltodextrin of the same packaging and quantity', 'interventionNames': ['Combination Product: nutritional supplements']}], 'interventions': [{'name': 'nutritional supplements', 'type': 'COMBINATION_PRODUCT', 'description': 'a daily supplement of branched-chain amino acids combined with medium-chain triglycerides', 'armGroupLabels': ['receive a daily supplement of branched-chain amino acids combined with medium-chain triglycerides', 'receive a daily supplement of maltodextrin of the same packaging and quantity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ding-cheng Chan, DR', 'role': 'CONTACT', 'email': 'dingchengchan@ntu.edu.tw', 'phone': '+886-2-23123456', 'phoneExt': '67095'}], 'facility': 'Department of Geriatrics and Gerontology, National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Wei-Jia Huang, Master', 'role': 'CONTACT', 'email': 'r98621207@ntu.edu.tw', 'phone': '+886-2-23123456', 'phoneExt': '67095'}], 'overallOfficials': [{'name': 'Ding-cheng Chan, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Geriatrics and Gerontology, National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}