Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-30 @ 4:59 PM
Study NCT ID:
NCT02385357
Status:
UNKNOWN
Last Update Posted:
2015-03-11
First Post:
2015-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Protein-enriched Drink on Muscle Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003286', 'term': 'Contracture'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-10', 'studyFirstSubmitDate': '2015-02-10', 'studyFirstSubmitQcDate': '2015-03-10', 'lastUpdatePostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Isometric muscle strength', 'timeFrame': 'Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink', 'description': 'Isometric muscle strength of lower limbs at 90% angle.'}], 'secondaryOutcomes': [{'measure': 'Muscle soreness of lower limbs self-reported by a visual anagogic scale and with an algometer score.', 'timeFrame': 'Change from post- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink', 'description': 'Muscle soreness of the lower limbs will be self-reported by a visual anagogic scale and with an algometer score.'}, {'measure': 'Power output assessed with the 30sec. Wingate anaerobic test', 'timeFrame': 'Change from post- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink', 'description': 'Power output will be assessed with the 30sec. Wingate anaerobic test.'}, {'measure': 'Creatine kinase', 'timeFrame': 'Change from post- protein-enriched drink to 24, 48 hrs post- protein-enriched drink', 'description': 'Creatine kinase will be assessed after the protein-enriched drink to assess muscle recovery after a high intensity exercise bout'}, {'measure': 'Urine Creatinine', 'timeFrame': 'Change from post- protein-enriched drink to 24, 48 hrs post- protein-enriched drink', 'description': 'Concentration of creatinine in urine will be assessed after the protein-enriched drink to assess muscle recovery after a high intensity exercise bout'}, {'measure': 'Resting metabolic rate', 'timeFrame': 'Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink'}, {'measure': 'Time limit (time that the participant is able to run 90% of his determined maximum aerobic velocity)', 'timeFrame': '24hrs after protein-enriched drink', 'description': 'We will measure the time that the participant is able to run 90% of his determined maximum aerobic velocity'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Muscle function', 'Anaerobic power', 'Muscle damage'], 'conditions': ['Contracture']}, 'descriptionModule': {'briefSummary': 'There is no conclusive evidence about the effect of intake of protein-enriched drink after and acute high intensity exercise bout on muscle function and damage. The investigators aimed to study the effect of a protein-enriched drink on muscle function recovery following an acute high intensity exercise bout. The present counterbalanced, crossover, and double blind study will involve a total of 12 active men.', 'detailedDescription': 'Participants will run downhill (-10%) during 30 min at a intensity equivalent to 75-80% of their maximum heart rate (previously determined). After the exercise bout, participants will have either the placebo or the experimental drink. The investigators will measure muscle function and damage-related parameters right after the exercise as well as the three following days. This protocol will be repeated after a wash out period of 3 weeks, where the participants will have the other drink. The investigators will control exercise and diet three weeks before study entry, during the experimental week as the investigators as during the wash out period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recreational triathletes with 2 years of experience\n* Maximum oxygen uptake : ≥55 ml/kg/min\n* Fat mass: 8-20% measured by dual energy x-ray absorptiometry\n* Not participating in another study\n* Not having ergogenic aids\n* Not participating in a weight loss program\n* Normal electrocardiogram\n* Participants must be capable and willing to provide consent, understand exclusion criteria and accept the randomized group assignment\n\nExclusion Criteria:\n\n* History of cardiovascular disease\n* Diabetes or hypertension\n* Medication for hypertension, hyperlipidemia, hyperuricemia or other illness.\n* Smoking\n* Other significant medical conditions that are life-threatening or that can interfere with or be aggravated by exercise.\n* Unwillingness to either complete the study requirements or to be randomized into control or training group.'}, 'identificationModule': {'nctId': 'NCT02385357', 'acronym': 'SPORTEUS', 'briefTitle': 'Effect of a Protein-enriched Drink on Muscle Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Puleva Biotech'}, 'officialTitle': 'Effect of a Protein-enriched Drink on Muscle Function Recovery Following an Acute High Intensity Exercise Bout', 'orgStudyIdInfo': {'id': 'Puleva'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': '330 ml of commercial protein-enriched drink (2.5 g/100 ml of protein)'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': '330 ml of protein-enriched drink (6 g/100 ml of protein)', 'interventionNames': ['Dietary Supplement: Protein-enriched drink']}], 'interventions': [{'name': 'Protein-enriched drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will drink 330 ml of a protein-enriched drink (6 g/ml of protein) after a high intensity exercise that induce muscle damage (30 min running downhill with a slope of -10º)', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18004', 'city': 'Granada', 'state': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Federico Lara, PhD', 'role': 'CONTACT', 'email': 'Federico.LaraVilloslada@puleva.es', 'phone': '0034958240100'}], 'facility': 'Biosearch Life', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'centralContacts': [{'name': 'Federico Lara, PhD', 'role': 'CONTACT', 'email': 'Federico.LaraVilloslada@puleva.es', 'phone': '0034958240100'}], 'overallOfficials': [{'name': 'Federico Lara, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Puleva Biotech'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Puleva Biotech', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Universidad de Granada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}