Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-25 @ 10:36 PM
Study NCT ID:
NCT01776359
Status:
COMPLETED
Last Update Posted:
2015-06-09
First Post:
2013-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of High Protein Intake With Intense Exercise and Energy Deficit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018753', 'term': 'Diet, Protein-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-06', 'studyFirstSubmitDate': '2013-01-14', 'studyFirstSubmitQcDate': '2013-01-23', 'lastUpdatePostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Composition', 'timeFrame': '4 weeks', 'description': 'To compare the effect of normal protein intake (1.2 g/kg per day) and increased protein intake (2.4 g/kg per day) on body composition over a 4 week period of energy restriction in young males (18-30), with intense exercise training. Body composition will be measured via DXA, Bod Pod, Bio-impedance, skin folds.'}], 'secondaryOutcomes': [{'measure': 'Psychological state', 'timeFrame': '4 weeks', 'description': 'To compare the psychological state of the participants, before, during and after the intervention. To see if the mind will grow with the body as high intensity exercise is performed, or whether the mind will tire and scores will be reduced. Measurement tactics will in include POMS, and PANAS questionnaires for mood, and stroop, isometric hand grip, operation span test, and vigilance task.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Muscle', 'Protein', 'Diet', 'Exercise'], 'conditions': ['Overweight']}, 'referencesModule': {'references': [{'pmid': '19927027', 'type': 'BACKGROUND', 'citation': 'Mettler S, Mitchell N, Tipton KD. Increased protein intake reduces lean body mass loss during weight loss in athletes. Med Sci Sports Exerc. 2010 Feb;42(2):326-37. doi: 10.1249/MSS.0b013e3181b2ef8e.'}, {'pmid': '10838463', 'type': 'BACKGROUND', 'citation': 'Demling RH, DeSanti L. Effect of a hypocaloric diet, increased protein intake and resistance training on lean mass gains and fat mass loss in overweight police officers. Ann Nutr Metab. 2000;44(1):21-9. doi: 10.1159/000012817.'}, {'pmid': '6704368', 'type': 'BACKGROUND', 'citation': 'Butterfield GE, Calloway DH. Physical activity improves protein utilization in young men. Br J Nutr. 1984 Mar;51(2):171-84. doi: 10.1079/bjn19840021.'}, {'pmid': '26817506', 'type': 'DERIVED', 'citation': 'Longland TM, Oikawa SY, Mitchell CJ, Devries MC, Phillips SM. Higher compared with lower dietary protein during an energy deficit combined with intense exercise promotes greater lean mass gain and fat mass loss: a randomized trial. Am J Clin Nutr. 2016 Mar;103(3):738-46. doi: 10.3945/ajcn.115.119339. Epub 2016 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'A four week intervention will take place with the participants. They will undergo 6 days a week of high intensity training. They will also be at a 40% energy deficiency. One group will have a normal intake of protein, 1.2g/kg, while the other will have 2.4g/kg. It is our thesis that the participants with the higher protein will retain more lean mass.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-30 males\n* Healthy\n\nExclusion Criteria:\n\n* more than 15% body fat\n* 35-50ml/kg/min VO2\n* BMI grater than 27'}, 'identificationModule': {'nctId': 'NCT01776359', 'acronym': 'RIPPED', 'briefTitle': 'Effects of High Protein Intake With Intense Exercise and Energy Deficit', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Effects of High Protein Intake With Intense Exercise and Energy Deficit', 'orgStudyIdInfo': {'id': 'REB 12-670'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Protein', 'description': 'High Protein', 'interventionNames': ['Dietary Supplement: High Protein']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low Protein', 'description': 'Low Protein', 'interventionNames': ['Dietary Supplement: Low Protein']}], 'interventions': [{'name': 'High Protein', 'type': 'DIETARY_SUPPLEMENT', 'description': '2.4g/kg of protein', 'armGroupLabels': ['High Protein']}, {'name': 'Low Protein', 'type': 'DIETARY_SUPPLEMENT', 'description': '1.2g/kg of protein', 'armGroupLabels': ['Low Protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S 4L8', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Stuart M Phillips, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Stuart M. Phillips', 'investigatorAffiliation': 'McMaster University'}}}}