Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT05869305
Status:
UNKNOWN
Last Update Posted:
2023-05-24
First Post:
2023-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Protein Product in Volunteers With Sarcopenia
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': 'D030262', 'term': 'Soybean Proteins'}], 'ancestors': [{'id': 'D010940', 'term': 'Plant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014674', 'term': 'Plant Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D045730', 'term': 'Soy Foods'}, {'id': 'D000067075', 'term': 'Vegetable Products'}, {'id': 'D014675', 'term': 'Vegetables'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '12 weeks', 'description': 'Using handgrip strength instrument (high value means high strength)'}, {'measure': 'Muscle mass', 'timeFrame': '12 weeks', 'description': 'Using Bioelectrical Impedance Analysis instrument (high value means high mass)'}, {'measure': 'Physical performance', 'timeFrame': '12 weeks', 'description': 'Using Gait speed (6-meter walk) (low time period and low score of tired mean high physical performance.'}, {'measure': 'Sarcopenia score', 'timeFrame': '12 weeks', 'description': 'Sarcopenia questionnaires (score 1 to 10 means low severity to high severity)'}, {'measure': 'Body weight', 'timeFrame': '12 weeks', 'description': 'Body weight of the patients'}, {'measure': 'Body mass index', 'timeFrame': '12 weeks', 'description': 'Body mass index of the patients'}], 'secondaryOutcomes': [{'measure': 'Nutritional status', 'timeFrame': '12 weeks', 'description': 'Nutritional score (score 0 to 17 means lack of nutrition, score 17 to 23.5 means risk to have lack of nutrition, score 24 to 30 means normal nutrition)'}, {'measure': 'Hungry feeling', 'timeFrame': '12 weeks', 'description': 'Using visual analogue scale 0 to 10 (No hungry to very hungry)'}, {'measure': 'Quality of life of the patient', 'timeFrame': '12 weeks', 'description': '36-Item Short Form Survey questionnaires shows in quality of life score 0 to 100 (High score means a better outcome)'}, {'measure': 'Concentration of total protein in serum', 'timeFrame': '12 weeks', 'description': 'Measure concentration of total protein in serum'}, {'measure': 'Concentration of immunoglobulin in serum', 'timeFrame': '12 weeks', 'description': 'Measure concentration of immunoglobulin in serum'}, {'measure': 'Concentration of glucose in serum', 'timeFrame': '12 weeks', 'description': 'Measure concentration of glucose in serum'}, {'measure': 'Concentration of calcium in serum', 'timeFrame': '12 weeks', 'description': 'Measure concentration of calcium in serum'}, {'measure': 'Concentration of magnesium in serum', 'timeFrame': '12 weeks', 'description': 'Measure concentration of magnesium in serum'}, {'measure': 'Concentration of sodium in serum', 'timeFrame': '12 weeks', 'description': 'Measure concentration of sodium in serum'}, {'measure': 'Concentration of creatinine in serum', 'timeFrame': '12 weeks', 'description': 'Measure concentration of creatinine in serum'}, {'measure': 'Concentration of blood urea nitrogen in serum', 'timeFrame': '12 weeks', 'description': 'Measure concentration of blood urea nitrogen in serum'}, {'measure': 'Concentration of aspartate transaminase in serum', 'timeFrame': '12 weeks', 'description': 'Measure concentration of aspartate transaminase in serum'}, {'measure': 'Concentration of alanine aminotransferase in serum', 'timeFrame': '12 weeks', 'description': 'Measure concentration of alanine aminotransferase in serum'}, {'measure': 'Concentration of alkaline phosphatase in serum', 'timeFrame': '12 weeks', 'description': 'Measure concentration of alkaline phosphatase in serum'}, {'measure': 'Skin reaction', 'timeFrame': '12 weeks', 'description': 'Found or not found'}, {'measure': 'Respiratory reaction', 'timeFrame': '12 weeks', 'description': 'Found or not found'}, {'measure': 'Gastrointestinal tract reaction', 'timeFrame': '12 weeks', 'description': 'Found or not found'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': 'The objective of this study are to evaluate efficacy and safety of protein product in volunteers with sarcopenia.', 'detailedDescription': 'There are 45 patients in this study. They are randomly divided into 3 groups which are whey protein isolate group, isolated soy protein group, placebo group. They will take the sample 1 sachet/day for 12 weeks. Muscle strength, muscle mass, physical performance, sarcopenia score, body weight, body mass index, protein, immunoglobulins, quality of life, liver function, kidney function, other laboratory value, and adverse effects are evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 20 years\n* Sarcopenia score more than 4\n* Handgrip strength less than 28 kg in male and less than 18 kg in female and muscle mass less than 7 kg/m2 in male and less than 5.7 kg/m2 in female or Gait speed (6-meter walk) less than 1 m/s\n* Can take protein from animal\n* Can read and write or have people to look after\n* Willing to participate in this study\n\nExclusion Criteria:\n\n* Allergic to protein from animals and plants\n* Hepatitis or cirrhosis\n* Glomerular disease or glomerular filtration rate less than 60 ml/min/1.73m2\n* Cancer or heart disease\n* Cannot walk\n* Pregnancy and lactation\n* Duodenal surgery\n* Take protein supplement within 2 weeks\n* Take protein in normal food more than 1.2 g/body weight/day\n* Participating in other studies'}, 'identificationModule': {'nctId': 'NCT05869305', 'briefTitle': 'Efficacy and Safety of Protein Product in Volunteers With Sarcopenia', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Efficacy and Safety of Protein Product in Volunteers With Sarcopenia', 'orgStudyIdInfo': {'id': 'IRBRTA 426/2566'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'whey protein isolate group', 'description': 'Whey protein isolate is contained in the sachet.', 'interventionNames': ['Dietary Supplement: whey protein isolate']}, {'type': 'EXPERIMENTAL', 'label': 'isolated soy protein group', 'description': 'Isolated soy protein, pea protein isolate, and brown rice protein are contained in the sachet.', 'interventionNames': ['Dietary Supplement: isolated soy protein']}, {'type': 'EXPERIMENTAL', 'label': 'placebo group', 'description': 'Base powder without proteins is contained in the sachet', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'whey protein isolate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Take 1 sachet/day for 12 weeks.', 'armGroupLabels': ['whey protein isolate group']}, {'name': 'isolated soy protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Take 1 sachet/day for 12 weeks.', 'armGroupLabels': ['isolated soy protein group']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Take 1 sachet/day for 12 weeks.', 'armGroupLabels': ['placebo group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pornanong Aramwit, Pharm.D., Ph.D', 'investigatorAffiliation': 'Chulalongkorn University'}}}}