Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 6:21 AM
Study NCT ID:
NCT07102667
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-11
First Post:
2025-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Between-Group Differences in Muscle Mass Changes at 6 Months', 'timeFrame': 'From enrollment to the end of intervention at 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcopenia', 'Chronic kidney disease', 'Protein intake', 'Nutrition'], 'conditions': ['Sarcopenia', 'Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine whether increasing protein intake in elderly adults with pre-dialysis chronic kidney disease, in combination with resistance exercise, improves muscle mass without worsening renal function.The main questions it aims to answer are:\n\n* Does a protein intake of 1.2 g/kg BW/day combined with exercise improve muscle mass better than a protein intake of 1.0 g/kg BW/day?\n* Does a protein intake of 1.2 g/kg BW/day combined with exercise lead to greater improvements in muscle strength and function?\n* Does a protein intake of 1.2 1.2 g/kg BW/day combined with exercise cause a decline in renal function (eGFR) compared to a protein intake of 1.0 1.2 g/kg BW/day?\n\nResearchers will compare a group assigned to intake 1.2 g/kg BW/day of protein with another group assigned to intake 1.0 g/kg BW/day, to assess whether the higher intake improves muscle mass and physical performance without causing harm.\n\nParticipants will\n\n* be assessed for body composition, physical performance and nutritional intake.\n* be assigned to consume protein at either 1.2 or 1.0 g/kg/day.\n* perform a home-based resistance exercise program using resistance bands.\n* provide blood and urine sample to monitor renal function.\n* visit the clinic at weeks 12 and 24 for repeated measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thai adults aged ≥ 65 years\n* Chronic kidney disease with estimated glomerular filtration rate (eGFR) 30-59 ml/min/1.73 m2\n* Sarcopenia or presarcopenia (diagnosis based on Asian Working Group for Sarcopenia (AWGS) 2019 definition)\n\nExclusion Criteria:\n\n* Active cardiopulmonary disease(s) or uncontrolled hypertension with contraindications to resistance training\n* Physically or cognitively unable to participate in the resistance exercise program (e.g. dementia), as determined by the attending physician\n* Limitations of body measurements and interpretation using Bioelectrical Impedance Analysis (BIA) e.g. presence of pacemaker, surgical metal implants\n* Meets the definition of AKI or AKD, defined as alterations in kidney function within the past 3 months\n* Severe vitamin D deficiency (25-OH Vitamin D level \\< 10 ng/mL)\n* Refuses to give consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT07102667', 'briefTitle': 'The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease: A Randomized Active-Controlled Trial', 'orgStudyIdInfo': {'id': '0182/68'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protein intake of 1.2 g/kg/day', 'interventionNames': ['Behavioral: Protein intake 1.2 g/kg/day and resistance exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Protein intake of 1.0 g/kg/day', 'interventionNames': ['Behavioral: Protein intake 1.0 g/kg/day and resistance exercise']}], 'interventions': [{'name': 'Protein intake 1.2 g/kg/day and resistance exercise', 'type': 'BEHAVIORAL', 'description': 'Protein intake of 1.2 g/kg/day in combination with resistance exercise using resistance bands', 'armGroupLabels': ['Protein intake of 1.2 g/kg/day']}, {'name': 'Protein intake 1.0 g/kg/day and resistance exercise', 'type': 'BEHAVIORAL', 'description': 'Protein intake 1.0 g/kg/day in combination with resistance exercise using resistance bands', 'armGroupLabels': ['Protein intake of 1.0 g/kg/day']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'facility': 'King Chulalongkorn Memorial Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Chawalya Angsuwatjarakorn, MD', 'investigatorAffiliation': 'Chulalongkorn University'}}}}