Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-25 @ 12:56 AM
Study NCT ID:
NCT02880657
Status:
UNKNOWN
Last Update Posted:
2016-08-26
First Post:
2016-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of SODB® (Superoxide Dismutase by Bionov®) in the Physical Condition Improvement in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-23', 'studyFirstSubmitDate': '2016-07-20', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with treatment-related adverse events', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'All adverse events occured throughout the study analyzed in order to know the number of participants only with treatment-related adverse events'}, {'measure': 'Description of oxidative marker modifications in blood', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by KRL (Kirial test) measurements'}, {'measure': 'Description of antioxidant markers modifications in blood', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by antioxidant enzymes measurements'}, {'measure': 'Description of Complete Blood Count modifications in blood', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)'}, {'measure': 'Description of serum protein modifications in blood', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by Serum Protein Electrophoresis measurements'}, {'measure': 'Description of lymphocytes nature modifications in blood', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by lymphocytes families percent measurements'}, {'measure': 'Description of Complement blood level modifications', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by C3, C4 and CH50 measurements'}], 'primaryOutcomes': [{'measure': 'Change from baseline physical condition at 10 weeks', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 5 weeks of treatment (V3) and 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by Ruffier test measurement'}], 'secondaryOutcomes': [{'measure': 'Evaluation of cardiac frequence', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by measurements of cardiac frequence during a physical test'}, {'measure': 'Evaluation of maximal aerobic vitesse', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by measurements of maximal aerobic vitesse during a physical test'}, {'measure': 'Evaluation of maximal oxygen volume', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by measurements of maximal oxygen volume during a physical test'}, {'measure': 'Evaluation of running time', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by measurements of running time during a physical test'}, {'measure': 'Evaluation of running distance', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by measurements of running distance during a physical test'}, {'measure': 'Evaluation of quality of fatigue', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by an auto scale (Prévost)'}, {'measure': 'Evaluation of quality of life', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by an auto scale (SF36)'}, {'measure': 'Evaluation of glucose blood level', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by glucose measurements'}, {'measure': 'Evaluation of insulin blood level', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by insulin measurements'}, {'measure': 'Evaluation of cholesterol level', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by total and LDL-cholesterol measurements'}, {'measure': 'Evaluation of triglycerides level', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by triglycerides measurements'}, {'measure': 'Evaluation of inflammation', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by CRP (C-reactive protein) measurements'}, {'measure': 'Evaluation of ions modifications', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by ionogram measurements'}, {'measure': 'Evaluation of creatinemia', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by creatinine measurements'}, {'measure': 'Evaluation of lactate level', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by lactate measurements'}, {'measure': 'Evaluation of transaminases level', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by transaminases measurements'}, {'measure': 'Evaluation of cortisol level', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by cortisol measurements'}, {'measure': 'Evaluation of testosterone level', 'timeFrame': 'Evaluation performed at inclusion day (V2) and after 10 weeks of treatment at the end of the study (V4)', 'description': 'Evaluation performed by testosterone measurements'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['superoxide dismutase', 'melon concentrate', 'oxidative stress', 'physical training'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the influence of a 10 weeks SODB® supplementation in physical condition improvements of healthy subjects, in comparison to a placebo.', 'detailedDescription': 'Beneficial experimental results have already been obtained with SODB®. That is why, the investigators expect several effects of SODB® here. Indeed, this clinical study could show that SODB® is able to improve physical conditions, and particularly at muscular and cardiac levels, by inducing a decrease in oxidative stress.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ruffier score between 8 and 12\n* 18.5 \\< Body Mass Index \\< 27 kg/m2\n* stable weight (variation \\< 5% over the last 3 months)\n* stable diet over the last 3 months\n* normal biological exam\n* arterial pressure \\< 140/90 mm Hg\n* normal ECG\n* no contraindication for running\n* subject having given his free, informed and express consent\n* subject affiliated with a social security insurance or beneficiary of such an insurance system\n* time to go to the physical training twice per week\n\nExclusion Criteria:\n\n* subject who do not understand the study\n* \\> 5 cigarets per day\n* slimming diet over the last 3 months\n* contraindication for running or physical test\n* subject who failed the Cooper test\n* anormal ECG\n* anormal biological results\n* dyslipidemia\n* under current statins treatment\n* hypertension\n* diabeta II\n* chronic respiratory disease\n* rheumatic disease\n* orthopedic disease\n* positive serology for hepatitis B, C or HIV\n* under current corticoids treatment\n* under current drugs (medicine or not)\n* any allergy to utilized one of the compounds of the experimental or placebo product\n* alcool \\> 36g/day\n* consumption of drinks containing caffein, taurine, creatin, guarana, ginseng, ginkgo, biloba, etc\n* consumption of drinks containing xanthic bases (\\> 0.5L/day)\n* consumption of drinks containing plants (\\> 2L/day)\n* consumption of grapefruit juice (\\> 0.5L/day)\n* under current antioxidant treatment (and during last month)\n* adult protected by the law\n* any subject who participated to a clinical assay within the 3 months'}, 'identificationModule': {'nctId': 'NCT02880657', 'acronym': 'MELORUN560', 'briefTitle': 'Evaluation of SODB® (Superoxide Dismutase by Bionov®) in the Physical Condition Improvement in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bionov'}, 'officialTitle': 'Evaluation of SODB®, Associated With a Physical Training, in the Physical Condition Improvement in Healthy Subjects: Randomized Double-blind Study Versus Placebo', 'orgStudyIdInfo': {'id': '2016-A00302-49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SODB®-physical training', 'description': 'This arm receives daily two capsules of SODB® 40mg containing 560 UI of superoxide dismutase, associated with standardized physical training', 'interventionNames': ['Dietary Supplement: SODB®']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo-physical training', 'description': 'This arm receives daily two capsules of Placebo containing excipients only, associated with standardized physical training', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'SODB®', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects are supplemented with SODB®, daily over 10 weeks. Each volunteer was seen for the 4 visits: - visit of pre-inclusion V1, - visit V2, so-called inclusion visit, - visit V3 after 4 weeks of physical training and - visit V3 after 8 weeks of physical training', 'armGroupLabels': ['SODB®-physical training']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects are supplemented with Placebo, daily over 10 weeks. Each volunteer was seen for the 4 visits: - visit of pre-inclusion V1, - visit V2, so-called inclusion visit, - visit V3 after 4 weeks of physical training and - visit V3 after 8 weeks of physical training', 'armGroupLabels': ['Placebo-physical training']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dominique Lacan', 'role': 'CONTACT', 'email': 'dominique.lacan@bionov.fr', 'phone': '33(0)6 84 95 39 95'}, {'name': 'Julie Carillon', 'role': 'CONTACT', 'email': 'jc.rech@bionov.fr', 'phone': '33(0)6 40 20 14 78'}], 'overallOfficials': [{'name': 'Claire Thalamas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CIC Hospital Purpan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bionov', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}