Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-01 @ 3:42 PM
Study NCT ID:
NCT05673395
Status:
COMPLETED
Last Update Posted:
2023-01-17
First Post:
2022-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drinking Effect of Electrolyzed Alkaline Reduced Water on Oxidative Stress and Fatigue After Intense Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double blind (participants, investigator)'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The participants were randomly divided into two groups (n = 12) according to the sequence of random numbers obtained through an online number generator. After the first clinical trial, A wash-out period of one week was applied to prevent carry-over before crossing over, and the second clinical trial was performed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-13', 'studyFirstSubmitDate': '2022-12-19', 'studyFirstSubmitQcDate': '2022-12-31', 'lastUpdatePostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EARW consumption is effective in reducing oxidative stress', 'timeFrame': '15 minutes', 'description': 'Reactive oxygen species, nitric oxide, glutathione peroxidase, malondialdehyde'}], 'secondaryOutcomes': [{'measure': 'The effects of EARW consumption on exercise-induced fatigue markers in healthy young adults', 'timeFrame': '15 minutes', 'description': 'Lactate levels, phosphate levels, cytokines'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test the drinking effect of electolyzed alkaline reduced water (ARW) generated from alkaline ionizer (CGM MWPI-2101) on oxidative stress and fatigue after high-intensity exercise in healthy people. The main question\\[s\\] it aims to answer are:\n\n* \\[question 1\\] Can pH 9.5 EARW reduce oxidative stress compared to purified water (PW)\n* \\[question 2\\] Can pH 9.5 EARW decrease fatigue markers in blood\n\nParticipants will drink water from the experimental device after high-intensity exercise. Blood sample will be collected before exercise, after highly intensive exercise, and after then 15 min. of drinking water.\n\nResearchers will compare EARW group and PW group to see the anti-oxidative and anti-fatigue effects.', 'detailedDescription': 'This study was designed as a randomized, controlled, crossover, double-blind clinical trial with a single intervention of ARW intake (pH 9.5, 10 mL/kg body weight) after highly intense exercise.\n\nThe participants were divided into two groups, wherein they consumed either purified water (PW group) or EARW (EARW group). Blood samples were collected before exercise, immediately after exercise, and 15 min after drinking water.\n\nFor the anti-oxidative effect, ROS, NO, GPx, and MDA levels were measured. For the anti-fatigue effect, latate, lactate dehydrogenase, phosphate and calcium were measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male participants aged 19-25 years\n* physically active with a normal body mass index (BMI)\n* had not smoked for 3 months or consumed alcohol for more than a week prior to the start of the study.\n\nExclusion Criteria:\n\n* any kind of visible or known disease\n* hypertension,\n* musculoskeletal injuries in the previous three months,\n* breathing difficulties,\n* metabolic diseases,\n* autoimmune disease,\n* rash,\n* urticaria.'}, 'identificationModule': {'nctId': 'NCT05673395', 'briefTitle': 'Drinking Effect of Electrolyzed Alkaline Reduced Water on Oxidative Stress and Fatigue After Intense Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Wonju Severance Christian Hospital'}, 'officialTitle': 'Effects of Alkaline-reduced Water Generated From Electrolyzed Device (CGM MWPI-2101) on High-intensity Exercise-induced Oxidative Stress and Fatigue in Young Male Healthy Adults: Controlled, Randomized, Double-blind Clinical Trial', 'orgStudyIdInfo': {'id': 'EMB-2022-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EARW group', 'description': 'This group drink electrolyzed alkaline reduced water (EARW, pH 9.5) 10 mL/kg body weight in 10 min after exercise.', 'interventionNames': ['Device: Electrolyzed alkaline reduced water generator']}, {'type': 'SHAM_COMPARATOR', 'label': 'PW group', 'description': 'PW is purified water generated from sham device, and PW group drink 10 mL/kg body weight in 10 min after exercise.', 'interventionNames': ['Device: Electrolyzed alkaline reduced water generator']}], 'interventions': [{'name': 'Electrolyzed alkaline reduced water generator', 'type': 'DEVICE', 'otherNames': ['Electrolyzed alkaline ionizer (CGM MWPI-2101'], 'description': 'Participants drink water (10 mL/kg body weight) generated from the device after intensive excercise.', 'armGroupLabels': ['EARW group', 'PW group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26426', 'city': 'Wŏnju', 'state': 'Ganwon-do', 'country': 'South Korea', 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'overallOfficials': [{'name': 'Kyu-Jae Lee, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': '20, Ilsan-dong, Wonju, Gangwon-do, South Korea, 26426'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyu Jae Lee', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ceragem Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kyu Jae Lee', 'investigatorAffiliation': 'Wonju Severance Christian Hospital'}}}}