Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT04617951
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2020-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Ishige Okamurae Extract on Musculoskeletal Biomarkers in Adults With Relative 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2020-10-23', 'studyFirstSubmitQcDate': '2020-11-02', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'muscle strength', 'timeFrame': '12 weeks', 'description': 'the peak torque at 60°/s knee extension (/kg)'}], 'secondaryOutcomes': [{'measure': 'appendicular skeletal mass/(height x height)', 'timeFrame': '12 weeks', 'description': 'using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks'}, {'measure': 'appendicular skeletal mass/weight x 100', 'timeFrame': '12 weeks', 'description': 'using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks'}, {'measure': 'skeletal Muscle Mass Index/(height x height)', 'timeFrame': '12 weeks', 'description': 'using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks'}, {'measure': 'concentration of creatinine kinase (IU/L)', 'timeFrame': '12 weeks', 'description': 'creatinine kinase (IU/L) measured at baseline and after 12 weeks'}, {'measure': 'concentration of lactate (mg/dL)', 'timeFrame': '12 weeks', 'description': 'lactate (IU/L) measured at baseline and after 12 weeks'}, {'measure': 'EuroQol five dimensional three levels', 'timeFrame': '12 weeks', 'description': 'an index of life quality, minimum, maximum values (-0.171, 1), higher scores mean a better outcome, which will be measured at baseline and after 12 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '36238450', 'type': 'DERIVED', 'citation': 'Lee SR, Lee YL, Lee SY. Effect of Ishige okamurae extract on musculoskeletal biomarkers in adults with relative sarcopenia: Study protocol for a randomized double-blind placebo-controlled trial. Front Nutr. 2022 Sep 27;9:1015351. doi: 10.3389/fnut.2022.1015351. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Ishige Okamurae extracts on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia for 12 weeks.', 'detailedDescription': 'A previous study has indicated that Ishige Okamurae extracts may increase muscle mass and strength. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Ishige Okamurae extracts on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia; the safety of the compound are also evaluated. The Investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline, as well as after 6 and 12 weeks of intervention. Eighty adults were administered either 300 mg of Ishige Okamurae extracts or a placebo each day for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<110% of the standard lean body mass as measured using the body composition analyzer\n* Body mass index (BMI) ranging from 18.5 to 30.0 kg/m2\n* Those who have an average protein intake of 60 g or more/day.\n\nExclusion Criteria:\n\n* Abnormal liver or renal function (more than twice the normal upper limit of the research institute)\n* Uncontrolled diabetes mellitus (\\>160 mg/dL of fasting blood sugar)\n* History of fracture during the previous year\n* Uncontrolled hypertension (\\>160/100 mmHg)\n* Uncontrolled thyroid diseases.\n* History of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months\n* History of any central bone fracture within 1 year\n* History of medication for psychiatric diseases such as severe depression, schizophrenia, drug intoxication.\n* Alcohol abuser\n* Allergic reaction to Ishige Okamurae\n* Those who participated in other drug clinical trials within 1 month from the screening date.\n* Severe gastrointestinal symptoms such as heartburn and indigestion\n* Those who are pregnant, lactating, or plan to become pregnant during the clinical trial\n* Those who are judged to be unsuitable by the PI for other reasons'}, 'identificationModule': {'nctId': 'NCT04617951', 'briefTitle': 'Effect of Ishige Okamurae Extract on Musculoskeletal Biomarkers in Adults With Relative Sarcopenia', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Yangsan Hospital'}, 'officialTitle': 'Effect of Ishige Okamurae Extract on Musculoskeletal Biomarkers in Adults With Relative Sarcopenia: a Randomized, Double-blinded, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '02-2020-029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ishige Okamurae extracts group', 'description': 'This group takes Ishige Okamurae extracts for 12 weeks.', 'interventionNames': ['Dietary Supplement: Ishige Okamurae extracts group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'This group takes placebo for 12 weeks.', 'interventionNames': ['Dietary Supplement: Placebo group']}], 'interventions': [{'name': 'Ishige Okamurae extracts group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ishige Okamurae extracts 300 mg/day for 12 weeks', 'armGroupLabels': ['Ishige Okamurae extracts group']}, {'name': 'Placebo group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo 300 mg/day for 12 weeks', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50612', 'city': 'Yangsan', 'state': 'Gyeungsangnam-do', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Sang Yeoup Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Yangsan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sang Yeoup Lee', 'investigatorAffiliation': 'Pusan National University Yangsan Hospital'}}}}