Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-05 @ 5:48 PM
Study NCT ID:
NCT03297151
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2017-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein Supplementation and Recovery of Muscle Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067796', 'term': 'Whey'}], 'ancestors': [{'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-09', 'size': 777361, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-09-25T04:08', 'hasProtocol': True}, {'date': '2016-12-09', 'size': 607802, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2017-09-25T04:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double blind (participant and investigator)'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Block randomised, between group study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2021-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2017-08-17', 'studyFirstSubmitQcDate': '2017-09-25', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Muscle Contractile Function', 'timeFrame': 'Day 9, 10, 11, 12, 13, 14, 15, 16 and 17', 'description': 'Maximal Voluntary Contract (MVC) of Knee Extensor Muscle measured by laboratory-based ergometry'}], 'secondaryOutcomes': [{'measure': 'Change in Muscle Protein Synthesis', 'timeFrame': 'Day 11 and 16', 'description': 'The fractional rate of muscle protein synthesis (MPS) measured by deuterium incorporation into skeletal muscle sampled by microbiopsy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resistance Training', 'Muscle Function', 'Protein Synthesis'], 'conditions': ['Resistance Training', 'Muscle Damage']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://FHI.ie', 'label': 'Food For Health Ireland National Technology Centre'}]}, 'descriptionModule': {'briefSummary': 'The focus is performance nutrition. Resistance exercise can induce low level muscle damage in conjunction with impaired contractile function. Milk-derived proteins contain, or induce, bioactive properties that assist muscle recovery and restore/improve muscle function. The aim of the research is the recovery of muscle function following resistance exercise.\n\nIn this study, the investigators propose to undertake a comparison of the ingestion of two milk-derived protein-based recovery drinks on muscle function after resistance exercise compares to an isonitrogenous, non-essential amino acid control.', 'detailedDescription': 'Study Design: A block randomised design of 3 groups of resistance-exercise trained (RET) men\n\nParticipants: 24 young, healthy, resistance exercise trained, males aged 18 - 35 years.\n\nRecovery drinks; CONTROL - an isonitrogenous, non-essential amino acid solution; PROTEIN - a milk-based whey protein concentrate (WPC), WPC-80; HYDROLYSATE - a hydrolysed derivative of WPC-80.\n\nDay 1, Pre-screening consisting of:\n\n* medical history and examination by a clinician\n* blood sample to be evaluated for health-related contraindications\n* body composition measurement by dual energy x-ray absorptiometry (DXA) to determine whole body and segmental lean tissue mass;\n* exercise training log (6 month recall);\n* dietary consultation;\n* habitual physical activity level assessed by European Physical Activity Questionaire (EPAQ)-2\n\nDay 2 - 8: Participants will be "free-living" during this time. Participants will record dietary intake under the guidance of a qualified dietitian and sports nutritionist.\n\nDay 9 and 10: Participants will complete two familiarisation sessions to the resistance exercise and muscle function testing procedures.\n\nA single blood sample (5ml) will be drawn following o/n fast on each day. On day 2 participants will drink a metered dose of deuterated water (around 200ml) containing deuterium. A saliva sample will be taken before and after consuming this bolus.\n\nDay 11-17. During this experimental phase diet is prescribed and provided. The diet is based on habitual food intake standardized to body mass.\n\nDay 11: O/n fasted blood, saliva and 1st micro-biopsy of muscle obtained; Muscle function measured prior to and upon completion of a prescribed bout of resistance exercise training (RET); The recovery drink (0.33 g protein/kg body mass) is ingested; 3 hours following completion of RET a 2nd micro-biopsy of muscle is obtained.\n\nDay 12: O/n fasted blood and saliva is obtained Muscle function measured and recovery drink (0.33 g protein/kg body mass) consumed.\n\nDay 13: O/n fasted blood and saliva is obtained Muscle function measured followed by the 2nd RET bout and recovery drink (0.33 g protein/kg body mass) consumed.\n\nDay 14: O/n fasted blood and saliva is obtained Muscle function measured and recovery drink (0.33 g protein/kg body mass) consumed.\n\nDay 15: O/n fasted blood and saliva is obtained Muscle function measured followed by the 3rd RET bout and recovery drink (0.33 g protein/kg body mass) consumed.\n\nDay 16 O/n fasted blood, saliva and 3rd micro-biopsy of muscle obtained Muscle function measured and recovery drink (0.33 g protein/kg body mass) consumed.\n\nDay 17: O/n fasted blood and saliva is obtained Muscle function measured'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* risk\n* no known current illness or physically active\n* resistance-exercise trained\n* no known intolerance to milk-based products\n* no known blood born disease or medication that would adversely affect participation\n* no adverse risk to venepuncture\n\nExclusion Criteria:\n\n• recent musculoskeletal injury'}, 'identificationModule': {'nctId': 'NCT03297151', 'briefTitle': 'Protein Supplementation and Recovery of Muscle Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Limerick'}, 'officialTitle': 'The Effect of Milk Derived Protein Supplementation on Muscle Recovery Following Resistance Exercise', 'orgStudyIdInfo': {'id': 'FHIHAPN3.3RX'}, 'secondaryIdInfos': [{'id': 'TC20130001', 'type': 'OTHER_GRANT', 'domain': 'Enterprise Ireland'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'CONTROL', 'description': 'Intervention: Dietary Supplement: Non-essential amino acids A group of subjects ingesting a liquid beverage (per kilogram body mass: 0.33g non-essential amino acids dissolved in water ) prior to completion of a prescribed resistance exercise training (RET) session.\n\nMuscle Contractile Function to be conducted prior to and following the RET session by laboratory-based ergometry.\n\nMuscle Protein Synthesis induced by RET to be measured by deuterium incorporation in to skeletal muscle sampled by microbiopsy.', 'interventionNames': ['Dietary Supplement: CONTROL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PROTEIN', 'description': 'Intervention: Dietary Supplement: Whey Protein Concentrate A group of subjects ingesting a liquid beverage (per kilogram body mass: 0.33g of Whey Protein Concentrate dissolved in water ) prior to completion of a prescribed resistance exercise training (RET) session.\n\nMuscle Contractile Function to be conducted prior to and following the RET session by laboratory-based ergometry. Muscle Protein Synthesis induced by RET to be measured by deuterium incorporation in to skeletal muscle sampled by microbiopsy.', 'interventionNames': ['Dietary Supplement: Whey Protein Concentrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HYDROLYSATE', 'description': 'Intervention: Dietary Supplement: Whey Protein Hydrolysate A group of subjects ingesting a liquid beverage (per kilogram body mass: 0.33g of Whey Protein Hydrolysate dissolved in water ) prior to completion of a prescribed resistance exercise training (RET) session.\n\nMuscle Contractile Function to be conducted prior to and following the RET session by laboratory-based ergometry. Muscle Protein Synthesis induced by RET to be measured by deuterium incorporation in to skeletal muscle sampled by microbiopsy.', 'interventionNames': ['Dietary Supplement: Whey Protein Hydrolysate']}], 'interventions': [{'name': 'CONTROL', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Food grade mixture of non-essential amino acids in powdered form, flavoured and instantised to be dissolved in water.\n\nSupplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Product Reference Number 10955', 'armGroupLabels': ['CONTROL']}, {'name': 'Whey Protein Concentrate', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Carbelac80 Instant'], 'description': 'Whey protein concentrate in powdered form, flavoured and instantised to be dissolved in water.\n\nSupplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Trade name of product is Carbelac80 Instant Product Reference Number 10431', 'armGroupLabels': ['PROTEIN']}, {'name': 'Whey Protein Hydrolysate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Whey protein concentrate hydrolysate (degree of hydrolysate 27%) in powdered form, flavoured and instantised to be dissolved in water.\n\nSupplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Product Reference Number 10468', 'armGroupLabels': ['HYDROLYSATE']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Limerick', 'state': 'Co Limerick', 'country': 'Ireland', 'facility': 'University of Limerick', 'geoPoint': {'lat': 52.66472, 'lon': -8.62306}}], 'overallOfficials': [{'name': 'Philip M Jakeman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Limerick'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Limerick', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}