Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 10:50 PM
Study NCT ID:
NCT05828134
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2023-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Muscle Health and Metabolism in Pre-frail Middle-aged and Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'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': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-13', 'studyFirstSubmitDate': '2023-04-13', 'studyFirstSubmitQcDate': '2023-04-13', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline physical function after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'measured by hand grip, 6-minute walk distance, six-meter walking speed, 5 times sit-to-stand'}], 'secondaryOutcomes': [{'measure': 'Change from baseline numbers of Complete blood count after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline numbers of Complete blood count after 12 weeks'}, {'measure': 'Change from baseline concentration of Albumin after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of Albumin after 12 weeks'}, {'measure': 'Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks'}, {'measure': 'Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks'}, {'measure': 'Change from baseline concentration of blood urea nitrogen after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of blood urea nitrogen after 12 weeks'}, {'measure': 'Change from baseline concentration of Creatinin after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of Creatinin after 12 weeks'}, {'measure': 'Change from baseline concentration of Fasting glucose after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of Fasting glucose after 12 weeks'}, {'measure': 'Change from baseline concentration of Fasting insulin after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of Fasting insulin after 12 weeks'}, {'measure': 'Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks'}, {'measure': 'Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks'}, {'measure': 'Change from baseline concentration of Leptin after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of Leptin after 12 weeks'}, {'measure': 'Change from baseline concentration of urine protein after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of urine protein after 12 weeks'}, {'measure': 'Changes form baseline QUALITY OF LIFE after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'measured by the 36-Item Short Form Health Survey (SF-36), ranged 0-100, higher values represent a better condition'}, {'measure': 'Change from baseline Nutrition intake after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition'}, {'measure': 'Change from baseline depression after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition'}, {'measure': 'Change from baseline cognitive ability after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'measured by Montreal Cognitive Assessment (MoCA) , ranged 0-30, higher values represent a better condition'}, {'measure': 'Change from baseline body composition analysis after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'measured by RASM'}, {'measure': 'Change from baseline concentration of Total Cholesterol after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of Total Cholesterol after 12 weeks'}, {'measure': 'Change from baseline concentration of Triglyceride after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of Triglyceride after 12 weeks'}, {'measure': 'Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks'}, {'measure': 'Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks'}, {'measure': 'Change from baseline concentration of dehydroepiandrosterone after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change from baseline concentration of dehydroepiandrosterone after 12 weeks'}, {'measure': 'Change in International Physical Activity Questionnaire (IPAQ) after 12 weeks', 'timeFrame': 'baseline, 4, 12 weeks', 'description': 'Change in physical activity measured by IPAQ, indicates that spent being physically active thin the prior 7 days.There are no established thresholds for presenting MET-minutes, the IPAQ Research Committee proposes that reported as comparisons of median values and interquartile ranges for different populations from baseline to 12 weeks in all participants.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laurel Corporation', 'Protein-Enriched Soup'], 'conditions': ['Muscle Loss', 'Muscle Weakness']}, 'descriptionModule': {'briefSummary': "To evaluate the effects of protein-enriched soup plus exercise on muscle mass and muscle strength.\n\nBesides, the investigators use the valued-based healthcare standard set as well as the Center for Epidemiological Studies-Depression, Charlson's comorbidity index Montreal Cognitive Assessment , and Mini Nutritional Assessment as outcome measures and to use the trial in validate additional supplement protein-enriched soup plus exercise could improve the vitality and health of mid-aged and old adults.", 'detailedDescription': 'With aging, functions of every organs become to decline. Muscle mass, is one of the decline. According to previous research, adults would lose 40% among from aged 20 to 70. If muscle mass decline combining with the decline of muscle strength is so called Sarcopenia.When muscle mass decline, infectious risk gets higher, and resilience after illness gets lower. In addition, activity and life quality are also responsible for falling, cognitive difficulty, disability and mortality among seniors. We hope to find out the etiologies of Sarcopenia through this program and develop prevention strategy and model to mollify the the negative effect of rapid aging society.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. People who aged 50-75 years\n2. Patients with following characteristics:\n3. feeling loss in activity\n4. detecting decline in self's walking speed.\n5. feeling tired of doing everything.\n6. having fell in last year.\n7. People willing to follow the program and cooperate with us for following tracking.\n8. People who are neither vegan nor vegetarian\n9. People agree and be able to sign the informed consent.\n10. the protein of the daily meal are less than 1.0g/kg\n\nExclusion Criteria:\n\n1. People cannot intake provided meals (e.g.: vegans or vegetarians) or any other who is allergic to our diets.\n2. People with any disease affecting their limbs, including:\n3. having fracture on limbs in the past 6 months\n4. having severe arthritis in the past 6 months\n5. any other whom PI recognized as weak control of their nervous system( e.g.: Parkinson's disease and stroke).\n6. People with intermittent limp caused by peripheral artery diseases\n7. People with weak control of mental disorder\n8. People with weak control of Cardiopulmonary disease\n9. People with weak control of Malignant tumor\n10. People with weak control of kidney diseases (eGFR \\<60ml/min/1.73)\n11. People with Visual impairment and Hearing disorder which cannot help to complete the program.\n12. People who have underwent hormone treatment and planned to undergo hormone treatment during program session.\n13. Any other condition that PI recognized as not suitable"}, 'identificationModule': {'nctId': 'NCT05828134', 'briefTitle': 'Enhancing Muscle Health and Metabolism in Pre-frail Middle-aged and Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': 'Enhancing Muscle Health and Metabolism in Pre-frail Middle-aged and Older Adults: A Randomized Controlled Trial Investigating the Benefits of Protein-enriched Supplementation and Weekly Exercise', 'orgStudyIdInfo': {'id': 'YM109172F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care group', 'description': 'The control group only performed routine data collection and gave them dietary suggestion.'}, {'type': 'EXPERIMENTAL', 'label': 'Protein-enriched soup group', 'description': 'Protein-enriched soup /day for use as a supplement with meals and strength training /week', 'interventionNames': ['Other: protein-enriched soup']}], 'interventions': [{'name': 'protein-enriched soup', 'type': 'OTHER', 'description': 'The participants in experimental group have a protein-enriched soup a day and do exercise a week', 'armGroupLabels': ['Protein-enriched soup group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Yang Ming Chiao Tung University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Liang-Kung Chen, MD.PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laurel Enterprises Corporation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}