Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-30 @ 1:41 PM
Study NCT ID:
NCT01303432
Status:
COMPLETED
Last Update Posted:
2012-09-14
First Post:
2011-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Yogurts Supplemented With Mobilee on Joint Function in Healthy Individuals With Joint Discomfort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015014', 'term': 'Yogurt'}], 'ancestors': [{'id': 'D043302', 'term': 'Cultured Milk Products'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000074421', 'term': 'Fermented Foods'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'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': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-13', 'studyFirstSubmitDate': '2011-02-21', 'studyFirstSubmitQcDate': '2011-02-23', 'lastUpdatePostDateStruct': {'date': '2012-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in isokineic assessment of muscular strength', 'timeFrame': '3 months', 'description': 'The muscular isokinetic assessment determines peak torque, power mean and total work of a certain joint using a dynamometric computerized system. The principal parameter is the change from baseline in the peak torque of the affected joint in extension at a speed of 240º/sec measured in Nm (Newton-meter).'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in isokinetic assessment of muscular strength (other conditions)', 'timeFrame': '3 months', 'description': 'Change from baseline of peak torque (Nm), power mean (W) and total work (J) of the affected joint in extension at 180º/sec, and in flexion at 240º/sec and 180º/sec.'}, {'measure': 'Assessment of joint swelling, effusion', 'timeFrame': '3 months', 'description': 'Ultrasonography: Study of the synovial effusion degree (if any) measured in the longitudinal axis of the suprapatellar recess of the affected knee.Results are expressed as change from baseline in mm.'}, {'measure': 'Pain assessment (VAS)', 'timeFrame': '3 months', 'description': 'Time evolution of pain intensity as measured by Visual Analogue Scale (mm).'}, {'measure': 'SF-36 Health questionnaire', 'timeFrame': '3 months', 'description': 'Questionnaire SF36-v2 to measure physical and mental health.'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': '3 months', 'description': 'The safety assessment includes a register of the appearance of adverse events along the 3 months of the study'}, {'measure': 'Subjective evaluation of the intervention', 'timeFrame': '3 months', 'description': 'Questionnaire to evaluate the subjective perception of the efficacy of the intervention.'}, {'measure': 'Change from baseline in systolic blood pressure, hearth rate, general biochemical profile and body mass index at 3 months', 'timeFrame': '3 months', 'description': 'Safety assessment includes an evaluation at 3 months of changes from baseline on systolic blood pressure, hearth rate, general biochemical profile and body mass index'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Joint discomfort', 'Functional Food', 'Joint function', 'Mobilee'], 'conditions': ['Low Intensity Knee Gonalgia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cdti.es/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the daily eating of a yogurt supplemented with Mobile is effective in improving joint function and quality of life of individuals with low intensity gonalgia.', 'detailedDescription': 'The prevalence of low intensity gonalgia is relatively high in western population. The purpose of the present intervention study is to determine whether the daily consumption of a yogurt supplemented with Mobile is effective in improving joint function and quality of life of individuals with low intensity gonalgia. Previous research using in vitro and animal models have demonstrated the efficacy of Mobilee in reducing inflammation and promoting anabolic responses in joint tissues. In addition, in two previous human intervention trials, the effects of Mobilee in joint function had been assessed using isokinetic tests. The present trial aims to confirm those previous results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (between 20 and 70 years of age)\n* Subject with low intensity knee gonalgia (VAS pain intensity between 3 and 5cm during at least the last 6 months)\n* Healthy individual according to its medical records, physical and laboratorial parameters\n* Positive informed consent\n\nExclusion Criteria:\n\n* Individuals requiring acetaminophen or any other drug to control pain\n* Active rheumatoid arthritis or any other inflammatory joint disease\n* Oral treatment with corticosteroids 4 weeks before selection\n* Intra-articular treatment with corticosteroids 3 months before selection\n* Significant injury of the study joint 12 months before selection\n* Individuals receiving any drug or supplement for osteoarthritis\n* Individuals requiring any type of medical prescription to control pain'}, 'identificationModule': {'nctId': 'NCT01303432', 'briefTitle': 'Effect of Yogurts Supplemented With Mobilee on Joint Function in Healthy Individuals With Joint Discomfort', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bioiberica'}, 'officialTitle': 'Double-blind, Placebo-controlled Nutrition Intervention Trial, to Study Efficacy and Safety of Yogurts Supplemented With Mobilee on Joint Function, Joint Structure and Quality of Life of Adults With Low Intensity Gonalgia', 'orgStudyIdInfo': {'id': 'CTNS 001_03_2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobilee yogurt', 'description': 'Subjects eating daily on yogurt supplemented with Mobilee', 'interventionNames': ['Dietary Supplement: Yogurt supplemented with Mobilee']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo yogurt', 'description': 'Subjects receiving daily a standard yogurt', 'interventionNames': ['Dietary Supplement: Yogurt']}], 'interventions': [{'name': 'Yogurt supplemented with Mobilee', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One yogurt (125mL) per day including 80mg of Mobilee', 'armGroupLabels': ['Mobilee yogurt']}, {'name': 'Yogurt', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One yogurt (125mL) per day', 'armGroupLabels': ['Placebo yogurt']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43201', 'city': 'Reus', 'state': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Universitari Sant Joan de Reus', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}], 'overallOfficials': [{'name': 'Rosa Solà, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari Sant Joan de Reus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioiberica', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Technological Centre of Nutrition and Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}