Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-08 @ 11:18 PM
Study NCT ID:
NCT02954367
Status:
UNKNOWN
Last Update Posted:
2016-11-03
First Post:
2016-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meat and Whey Protein Supplementation in Endurance Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000069466', 'term': 'Red Meat'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'C008315', 'term': 'maltodextrin'}], 'ancestors': [{'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008460', 'term': 'Meat'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2016-10-19', 'studyFirstSubmitQcDate': '2016-11-01', 'lastUpdatePostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% Fat Mass (Body composition)', 'timeFrame': '10 weeks', 'description': 'Estimated with Densitometry (DEXA)'}, {'measure': 'Visceral Adipose Tissue Mass (g) (Body composition)', 'timeFrame': '10 weeks', 'description': 'Estimated with DEXA'}, {'measure': 'Total Fat Free mass (g) (Body composition)', 'timeFrame': '10 weeks', 'description': 'Estimated with DEXA'}, {'measure': 'Bone mineral density (g/cm3) (Body composition)', 'timeFrame': '10 weeks', 'description': 'Estimated with DEXA'}], 'secondaryOutcomes': [{'measure': 'Blood Glucose (mg/dl)', 'timeFrame': '10 weeks'}, {'measure': 'Creatine Kinase (Ul/l) -Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'Creatinine (mg/dl) - Blood markers -', 'timeFrame': '10 weeks'}, {'measure': 'Myoglobin (ng/ml) - Blood markers -', 'timeFrame': '10 weeks'}, {'measure': 'Total cholesterol (mg/dl) -Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'HDL cholesterol (mg/dl) -Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'LDL cholesterol (mg/dl) -Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'Aspartate amino transferasa (Ul/l) -Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'Triglycerides (mg/dl) -Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'Hemoglobin (g/dl) -Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'Erythrocyte (M/µL) -Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'Haematocrit (%) -Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'Mean corpuscular volume (cubic millimeter)-Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'Serum Transferrin (mg/dl) -Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'Transferrin saturation (%) -Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'Neutrophils (%) -Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'Lymphocyte (%) -Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'Monocytes (%) -Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'Ferritin, serum (ng/ml) -Blood markers-', 'timeFrame': '10 weeks'}, {'measure': 'Progressive maximal oxygen consumption test (Cardiorespiratory test)', 'timeFrame': '10 weeks', 'description': '\\- Maximum oxygen uptake (ml/kg/min)'}, {'measure': 'Time to exhaustion at maximal aerobic (min)', 'timeFrame': '10 weeks'}, {'measure': 'Gut microbiota determination by 16S rRNA Sequencing', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dietary Modification']}, 'referencesModule': {'references': [{'pmid': '36918416', 'type': 'DERIVED', 'citation': 'Moreno-Perez D, Lopez-Samanes A, Larrosa M, Larumbe-Zabala E, Centeno A, Roberts J, Naclerio F. Effects of protein-carbohydrate vs. carbohydrate alone supplementation on immune inflammation markers in endurance athletes: a randomized controlled trial. Eur J Appl Physiol. 2023 Jul;123(7):1495-1505. doi: 10.1007/s00421-023-05168-6. Epub 2023 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this project is to investigate the potential benefits of combining a new protein meat hydrolysates extract with a regular endurance training programme on (a) body composition (b) performance (c) muscle structure (d) immunology and (e) microbiota (f) haematological markers in endurance athletes', 'detailedDescription': 'PROYECT DESIGN This investigation involves a 10-week randomised, balanced, double blind parallel group between-subjects design, aimed to analyse the effects of combining endurance exercise and a post exercise nutrition strategy (hydrolysates meat protein (MEAT) + whey protein (W) or a isocaloric only carbohydrate placebo) on training outcomes, immunity and haematological variables after regular training and feeding intervention.\n\nParticipants will be divided in two-treatment groups 1) Hydrolysed meat-protein + whey (PROT); and 2) non-protein iso-energetic placebo (CHO). Once considered eligible for the study, and after an initial familiarisation period plus baseline tests (endurance performance body composition and blood extractions) participants will be randomly assigned to one of the intervention groups: PROT and CHO. Each group will follow a 10-week periodised endurance training intervention combined with one of the two specific supplementation treatments (PROT or CHO). Measurements of performance (VO2peak, vetilatory threshold and time to exhaustion at maximal aerobic intensity), body composition (fat and fat free mass), microbiota and haematology will be determined before and after the 10-week intervention period.\n\nOnce informed consent and health history have been obtained, after the baseline assessment (t1), participants will be divided into two similar profile groups, matched by body mass, age, sex and maximal oxygen uptake (VO2peak): (1) PROT (2) CHO\n\nINTERVENTION The intervention will comprise of a 10-week combined supplementation (MEAT + W and CHO) regular endurance-training programme.\n\nEndurance training Participants will commit to follow a polarised triphasic endurance-training model. This model contains three intensity zones calculated as low intensity \\[\\< the first ventilatory threshold (VT1), \\~ 70% HRmax\\]; moderate intensity \\[between VT1 and respiratory compensation point or ventilatory threshold 2 (VT2), \\>70 \\< 90% HRmax\\]; and high intensity \\[\\>VT2, 90% HRmax\\]. Participants will train 5 to 6 times per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity.\n\nCardiorespiratory test Participants will perform a maximal cardiorespiratory exercise test before the training period to determine peak oxygen uptake (VO2peak) and ventilatory thresholds. Percentage of HRmax and the 15 points (6 to 20) Borg Scale Rate of Perceive Exertion (RPE) will be used to appropriately select the load along the training intervention.\n\nSupplementation protocol Training days: Immediately (\\<10 min) after completing each training session, participants will consume a beverage containing 20g of supplement (10g MEAT + 10g W) plus 200 ml of orange juice or only carbohydrate placebo (maltodextrine and orange juice).\n\nNon-training days: before breakfast.\n\nSupplements and placebo will be provided in powder form and should be mixed with 200ml of orange juice and water at the moment of consumption.\n\nThe supplements and placebo will look and taste identical.\n\nThus a total of one 20g doses will be administered on a daily base. Participants are required to ingest a total of 70 for the total of 10 weeks of the study intervention.\n\nSupplements will be provided in 14 days intervals and distributed by a blinded researcher after participants return the empty bag of the supplement/placebo consumed during the previous 14 day period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years to 45\n* Vo2max \\>50ml/kg/min\n* Regularly trained athletes,\n* Minimum 3 years of experience in resistance training exercise,\n* Volunteers,\n\nExclusion Criteria:\n\n* any musculoskeletal injuries, metabolic conditions, or diseases;\n* use of medications, smoking, and nutritional supplements known to affect physical performance, muscle damage or recovery process (e.g., creatine, whey protein, and amino acids) within 6 weeks prior to the start of the study.'}, 'identificationModule': {'nctId': 'NCT02954367', 'briefTitle': 'Meat and Whey Protein Supplementation in Endurance Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Madrid'}, 'officialTitle': 'Effects of Meat Protein Administration on Body Composition, Strength, Immunological, Microbiota and Haematological Markers in Endurance Athletes', 'orgStudyIdInfo': {'id': 'BEEF-UEM-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PROTEIN (MEAT + WHEY)', 'description': 'Post workout (training days) or breakfast (non training days) 20g of meat protein (10g meat + 10g whey) mixed with 200ml of orange juice and water', 'interventionNames': ['Dietary Supplement: PROTEIN']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CARBOHYDRATE (CHO)', 'description': 'Post workout (training days) or breakfast (non training days) 20g of maltodextrin mixed with 200ml orange juice and water', 'interventionNames': ['Dietary Supplement: CARBOHYDRATE']}], 'interventions': [{'name': 'PROTEIN', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['100% BEEF'], 'description': 'Immediately (\\<10 min) after completing each training session (resistance training) participants will consume a beverage containing 20g of meat protein (10g) plus whey (10g) mixed with 200 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.', 'armGroupLabels': ['PROTEIN (MEAT + WHEY)']}, {'name': 'CARBOHYDRATE', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Maltodextrin'], 'description': 'Immediately (\\<10 min) after completing each training session (resistance training), participants will consume a beverage containing about 20g of maltodextrin mixed with 200 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.', 'armGroupLabels': ['CARBOHYDRATE (CHO)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'DIEGO MORENO, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Europea de Madrid'}, {'name': 'FERNANDO NACLERIO, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Greenwich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Greenwich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'DIEGO MORENO PÉREZ', 'investigatorAffiliation': 'Universidad Europea de Madrid'}}}}