Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT04612127
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2020-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of the Consumption of a Spinach Extract on Muscle Function in Subjects Over 50 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2020-10-15', 'studyFirstSubmitQcDate': '2020-10-27', 'lastUpdatePostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle function', 'timeFrame': 'From baseline to 90 days', 'description': 'Isokinetic dynamometry. Knee flexion and extension force'}, {'measure': 'Muscle function', 'timeFrame': 'From baseline to 90 days', 'description': 'Isometric dynamometry'}], 'secondaryOutcomes': [{'measure': 'Muscle mass', 'timeFrame': 'From baseline to 90 days', 'description': 'Dual X-ray absorptiometry (DEXA), measured in grams.'}, {'measure': 'Muscle mass', 'timeFrame': 'From baseline to 90 days', 'description': 'Bioimpedance, in grams.'}, {'measure': 'Balance', 'timeFrame': 'From baseline to 90 days', 'description': 'Force platform Kistler'}, {'measure': 'Health Questionnaire', 'timeFrame': 'From baseline to 90 days', 'description': 'Questionnaire Quality of life SF-36. It consists of 36 questions that assess the health and well-being of the person'}, {'measure': 'Nutritional survey', 'timeFrame': 'From baseline to 90 days', 'description': '24 hour memory'}, {'measure': 'Liver safety variables', 'timeFrame': 'It is measured on an empty stomach, before and after the consumption time (60 days) with the experimental product and the placebo product.', 'description': 'It is a blood test blood, with the aim of determining if there is any alteration in the liver.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia', 'Physical Exercise']}, 'descriptionModule': {'briefSummary': 'Controlled, randomized, single-center, double-blind clinical trial, with two parallel branches depending on the product consumed, to measure the efficacy of a supplement extracted from spinach on muscle strength in subjects over 50 years of age.', 'detailedDescription': 'Subjects who meet the selection criteria will make two visits to the laboratory to perform the tests established in the protocol. In addition, all subjects will develop a program of strength, polyarticular, individualized and progressive exercises in which the main muscle groups are worked. The program will be held three days a week (36 sessions). Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 50 and 75 years.\n* Body mass index less than 32.\n* Subjects who do not develop physical exercise scheduled on a weekly basis.\n* Subjects who have given written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Consumption during the 6 months prior to the study of functional food or supplement that modifies body composition.\n* Presence of absolute or relative contraindications dictated by the American College of Sports Medicine, for the performance of physical exercise.\n* Presence of chronic diseases that prevent the performance of a physical exercise program (disabling arthropathies, moderate / severe chronic lung disease, ischemic heart disease under treatment, arrhythmias, etc.).\n* Abuse in the ingestion of alcohol.\n* Present hypersensitivity or intolerance to any of the components of the products under study.\n* Inability to understand informed consent.\n* Serious or terminal illnesses.\n* Subjects with a body mass index above 32.\n* Pregnant or lactating women.\n* Inability to understand informed consent.'}, 'identificationModule': {'nctId': 'NCT04612127', 'acronym': 'SPISAR', 'briefTitle': 'Efficacy of the Consumption of a Spinach Extract on Muscle Function in Subjects Over 50 Years of Age', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica San Antonio de Murcia'}, 'officialTitle': 'Nutritional Clinical Trial to Evaluate the Efficacy of Daily Consumption for 12 Weeks of a Spinach Extract on Muscle Function in Subjects Over 50 Years of Age', 'orgStudyIdInfo': {'id': 'UCAMCFE-00016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group - Spinach', 'description': 'Consumption for 90 days of spinach extract (1000mg)\n\nFour capsules will be consumed per day, two with breakfast and two with lunch.', 'interventionNames': ['Dietary Supplement: Dietary supplement consumption and physical exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group Placebo (sucrose)', 'description': 'Four capsules will be consumed per day, two with breakfast and two with lunch.', 'interventionNames': ['Dietary Supplement: Dietary supplement consumption and physical exercise']}], 'interventions': [{'name': 'Dietary supplement consumption and physical exercise', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The consumption time of the experimental product was 90 days and the control consumption time was 90 days.\n\nDuring this time, training should be done three times a week.', 'armGroupLabels': ['Experimental group - Spinach', 'control group Placebo (sucrose)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30107', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Catholic University of Murcia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica San Antonio de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Francisco Javier López Román', 'investigatorAffiliation': 'Universidad Católica San Antonio de Murcia'}}}}