Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-26 @ 10:47 PM
Study NCT ID:
NCT05998603
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2023-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-sleep Protein Supplementation and Load Carriage Recovery in British Army Recruits
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063806', 'term': 'Myalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-23', 'studyFirstSubmitDate': '2023-08-03', 'studyFirstSubmitQcDate': '2023-08-11', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in lower body muscle function', 'timeFrame': '40-hours', 'description': 'The change in maximal vertical jump height in participants before and after the load carriage test'}], 'secondaryOutcomes': [{'measure': 'The change in urinary myoglobin', 'timeFrame': '40-hours', 'description': 'The relative change in concentration of urinary myoglobin (ng/ml) in participants before and after the load carriage test'}, {'measure': 'The change in urinary 3-methylhistidine', 'timeFrame': '40-hours', 'description': 'The relative change in concentration of urinary 3-methylhistidine (nmol/ml) in participants before and after the load carriage test'}, {'measure': 'The change in perceived muscle soreness', 'timeFrame': '40-hours', 'description': 'The relative change in perceived muscle soreness assessed via visual analogue scale. The participants were asked to record their perceived muscle soreness using a 0-10 Likert scale (e.g., 0=no pain, 10=severe pain that limits the ability to move).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Protein-energy; Imbalance', 'Muscle Soreness']}, 'descriptionModule': {'briefSummary': 'Load carriage is a common military activity and has been shown to induce acute exercise-induced muscle damage (EIMD) and impair muscle function. Protein supplementation can accelerate muscle recovery by attenuating EIMD and muscle function loss. This study investigated the impact of an additional daily bolus of protein prior to sleep throughout training on acute muscle recovery following a load carriage test in British Army recruits. Muscle function (maximal jump height), perceived muscle soreness and urinary markers of muscle damage were assessed before (PRE), immediately post (POST), 24-hours post (24h-POST) and 40-hours post (40h-POST) a load carriage test.', 'detailedDescription': 'British Army basic training (BT) is physically demanding with new recruits completing multiple bouts of physical activity each day with limited recovery. Load carriage is one of the most physically demanding BT activities and has been shown to induce acute exercise-induced muscle damage (EIMD) and impair muscle function. Protein supplementation can accelerate muscle recovery by attenuating EIMD and muscle function loss. This study investigated the impact of an additional daily bolus of protein prior to sleep throughout training on acute muscle recovery following a load carriage test in United Kingdom (UK) British Army recruits. A mixed group (men/women) over over 120 new recruits were randomised to dietary control (CON), carbohydrate placebo (PLA), moderate (20g; MOD) or high (60g; HIGH) protein supplementation. Muscle function (maximal jump height), perceived muscle soreness and urinary markers of muscle damage were assessed before (PRE), immediately post (POST), 24-hours post (24h-POST) and 40-hours post (40h-POST) a load carriage test. The underlying aim of this study was to assess whether additional protein intake could attenuate aspects of muscle damage from an acute load carriage test including muscle function, muscle soreness and biomarkers of muscle damage during short term recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled into British Army basic training\n* Medically fit to train and complete the load carriage test\n\nExclusion Criteria:\n\n* Not taking any other nutritional supplement\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT05998603', 'briefTitle': 'Pre-sleep Protein Supplementation and Load Carriage Recovery in British Army Recruits', 'organization': {'class': 'OTHER', 'fullName': 'Anglia Ruskin University'}, 'officialTitle': 'Pre-sleep Protein Supplementation Does Not Improve Recovery From Load Carriage in British Army Recruits', 'orgStudyIdInfo': {'id': '1076/MODREC/20B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High protein intake supplementation', 'description': 'A 60g daily dose of whey protein supplementation', 'interventionNames': ['Dietary Supplement: High protein intake']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate protein intake supplementation', 'description': 'A 20g dose of whey protein supplementation', 'interventionNames': ['Dietary Supplement: Moderate protein intake']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Carbohydrate placebo', 'description': 'An isocaloic maltodextrin carbohydrate placebo', 'interventionNames': ['Dietary Supplement: Carbohydrate maltodextrin placebo']}, {'type': 'OTHER', 'label': 'Control group, no supplementation', 'description': 'Control group, not taking any supplementation, only completing basic training activities', 'interventionNames': ['Other: Control no supplementation']}], 'interventions': [{'name': 'High protein intake', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The participants received a 60g whey protein bolus each evening prior to sleep pre and post a military load carriage test.', 'armGroupLabels': ['High protein intake supplementation']}, {'name': 'Moderate protein intake', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The participants received a 20g whey protein bolus each evening prior to sleep pre and post a military load carriage test.', 'armGroupLabels': ['Moderate protein intake supplementation']}, {'name': 'Carbohydrate maltodextrin placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The participants received an isocaloric carbohydrate bolus each evening prior to sleep pre and post a military load carriage test.', 'armGroupLabels': ['Carbohydrate placebo']}, {'name': 'Control no supplementation', 'type': 'OTHER', 'description': 'Control group, no supplementation, only basic training', 'armGroupLabels': ['Control group, no supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB1 1PT', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Anglia Ruskin University', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': 'Justin D Roberts, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anglia Ruskin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anglia Ruskin University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Exeter', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}