Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-09 @ 12:05 PM
Study NCT ID:
NCT07309120
Status:
COMPLETED
Last Update Posted:
2026-01-08
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition Ameliorates the Muscle Loss of Pre-sarcopenia in Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-19', 'size': 156278, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-12-08T15:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-06', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appendicular Skeletal Muscle Index (ASMI)', 'timeFrame': 'Baseline and 12 weeks after intervention', 'description': 'Muscle mass was assessed using bioelectrical impedance analysis (Tanita MC-780MA). The appendicular skeletal muscle index (ASMI, kg/m2) was calculated as appendicular skeletal muscle mass (ASM, kg) divided by height squared (m²).'}, {'measure': 'Handgrip Strength (HGS)', 'timeFrame': 'Baseline and 12 weeks after intervention', 'description': 'Functional performance was evaluated by handgrip strength (HGS, kg), measured with a digital hand dynamometer.'}, {'measure': 'Gait speed (m/s)', 'timeFrame': 'Baseline and 12 weeks after intervention', 'description': 'Gait speed was assessed as the time required to walk a 4 meters, expressed in meters per second (m/s).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metabolomics', 'supplemenation', 'pre-sarcopenia'], 'conditions': ['Low Muscle Mass', 'Low Muscle Strength', 'Low Physical Function']}, 'referencesModule': {'references': [{'pmid': '36081299', 'type': 'BACKGROUND', 'citation': 'Prado CM, Landi F, Chew STH, Atherton PJ, Molinger J, Ruck T, Gonzalez MC. Advances in muscle health and nutrition: A toolkit for healthcare professionals. Clin Nutr. 2022 Oct;41(10):2244-2263. doi: 10.1016/j.clnu.2022.07.041. Epub 2022 Aug 7.'}, {'pmid': '35777246', 'type': 'BACKGROUND', 'citation': 'Lee SY, Lee HJ, Lim JY. Effects of leucine-rich protein supplements in older adults with sarcopenia: A systematic review and meta-analysis of randomized controlled trials. Arch Gerontol Geriatr. 2022 Sep-Oct;102:104758. doi: 10.1016/j.archger.2022.104758. Epub 2022 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of a 12-week leucine-enriched protein supplementation in adults aged 60 years and more. Participants will undergo assessments of muscle mass and function, as well as metabolic profiles in blood, urine, and feces before and after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing to provide written informed consent.\n2. Participants who attend health check-ups at Songshan District, Taipei City, or at the Wellness Cultural Village, or who have participated in the pilot study.\n3. Adults aged 60 years or older, male or female.\n4. Able to ambulate independently.\n5. Meets at least one of the following sarcopenia criteria:\n\nGrip strength: Men \\< 28 kg; Women \\< 18 kg Gait speed: \\< 1.0 m/s Muscle mass (appendicular skeletal muscle mass / height²): Men \\< 7.0 kg/m²; Women \\< 5.7 kg/m²\n\nExclusion Criteria:\n\n1. Impaired renal function.\n2. Allergy or intolerance to protein supplements.\n3. Currently undergoing cancer treatment.\n4. Autoimmune diseases.\n5. Assessed by a physician as unsuitable to participate.'}, 'identificationModule': {'nctId': 'NCT07309120', 'briefTitle': 'Nutrition Ameliorates the Muscle Loss of Pre-sarcopenia in Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Nutrition Ameliorates the Muscle Loss of Pre-sarcopenia in Elderly', 'orgStudyIdInfo': {'id': '202100551A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protein Supplementation Group', 'interventionNames': ['Dietary Supplement: Participants consume two sachets daily over a 12-week intervention period.']}], 'interventions': [{'name': 'Participants consume two sachets daily over a 12-week intervention period.', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each 8 g serving provided 35 kcal, comprising 4.1 g of protein, 1 g of fat, and 2.4 g of carbohydrates.', 'armGroupLabels': ['Protein Supplementation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'state': 'Guishan', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to ethical and privacy considerations, individual participant data will not be publicly available. De-identified data may be shared upon reasonable request and with approval from the institutional review board.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}