Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-31 @ 5:43 PM
Study NCT ID:
NCT02057094
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2013-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Protein Supplementation on Lean Body Mass Recovery From Extreme Military Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000067796', 'term': 'Whey'}], 'ancestors': [{'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-19', 'studyFirstSubmitDate': '2013-12-05', 'studyFirstSubmitQcDate': '2014-02-04', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in lean body mass following SERE and recovery nutrition', 'timeFrame': 'days 1-2, days 18-19, and days 45-46', 'description': 'Days 1-2: baseline Days 18-19: completion of SERE training Days 45-46: completion of a 26 day recovery nutrition intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Military Operational Stress Reaction', 'Malnutrition (Calorie)', 'Weight Loss', 'Muscle Wasting']}, 'referencesModule': {'references': [{'pmid': '28385919', 'type': 'BACKGROUND', 'citation': 'Berryman CE, Sepowitz JJ, McClung HL, Lieberman HR, Farina EK, McClung JP, Ferrando AA, Pasiakos SM. Supplementing an energy adequate, higher protein diet with protein does not enhance fat-free mass restoration after short-term severe negative energy balance. J Appl Physiol (1985). 2017 Jun 1;122(6):1485-1493. doi: 10.1152/japplphysiol.01039.2016. Epub 2017 Apr 6.'}, {'pmid': '36117330', 'type': 'DERIVED', 'citation': 'Berryman CE, McClung HL, Sepowitz JJ, Gaffney-Stomberg E, Ferrando AA, McClung JP, Pasiakos SM. Testosterone status following short-term, severe energy deficit is associated with fat-free mass loss in U.S. Marines. Physiol Rep. 2022 Sep;10(18):e15461. doi: 10.14814/phy2.15461.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the physiological consequences of extreme military training and determine whether protein supplementation enhances recovery by promoting gains in lean body mass. This study will be conducted at the US Marine Survive, Evade, Resist, Escape (SERE) school at Camp Lejeune, North Carolina.\n\nSERE school may be an ideal setting to assess nutritional interventions that promote recovery from severe military operational stress, and identify innate or experiential variables that may lead to increased levels of resilience in Warfighters. Our laboratory has recently demonstrated the detrimental effects and stressful nature of SERE. Heart rates and stress-related hormones increased dramatically, with concomitant reductions in circulating anabolic hormones. Additionally, SERE causes significant weight loss (15-20 lbs), which probably included lean body mass. The effects of severe operational stress induced by SERE, particularly the loss of lean mass, may degrade physical performance, increase injury risk, and compromise military readiness. Under controlled laboratory conditions, consuming high protein diets or supplemental high-quality protein promotes muscle protein retention, enhances muscle protein synthesis, and protects lean body mass in response to stress. Whether consuming supplemental protein promotes lean mass recovery and physiological resilience following a 'real-world' military stress has not been determined. Further, the level of supplemental protein necessary to optimize recovery from extreme military operational stress has not been elucidated.\n\nUp to 90 US Marines will be enrolled in a 46-day double-blind, placebo-controlled trial. Using complex body composition measurements, kinetic modeling of human metabolism, blood sampling and cognitive and nutrition questionnaires, the consequences of SERE and the efficacy of protein recovery nutrition on lean mass accretion and Warfighter resilience will be assessed.\n\nWe hypothesize that consuming a specially formulated, high-quality supplemental protein ration item will speed recovery of lean body mass, physiological, and psychological resilience following extreme military operational stress."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* US Marines at least 18 years old, enrolled in US Marine SERE school\n\nExclusion Criteria:\n\n* Self-reported allergies to dairy products'}, 'identificationModule': {'nctId': 'NCT02057094', 'briefTitle': 'Effects of Protein Supplementation on Lean Body Mass Recovery From Extreme Military Training', 'organization': {'class': 'FED', 'fullName': 'United States Army Research Institute of Environmental Medicine'}, 'officialTitle': 'Effect of Protein Supplementation on Lean Body Mass Recovery and Physiological Resilience Following Survive, Evade, Resist, Escape (SERE) School', 'orgStudyIdInfo': {'id': '14-02H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Dining facility recovery feeding only, no supplemental protein consumed (an isoenergetic, carbohydrate supplement will be consumed by those assigned to the Control group)', 'interventionNames': ['Dietary Supplement: Protein, High-Protein, and Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Protein', 'description': 'Consume dining facility food with:\n\n2, 20 g whey protein supplements daily (for \\~27 days)\n\n1, 40 g casein protein supplement daily (for \\~27 days)', 'interventionNames': ['Dietary Supplement: Protein, High-Protein, and Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High-Protein', 'description': 'Consume dining facility food with:\n\n2, 40 g whey protein supplements daily (\\~27 days)\n\n1, 50 g casein protein supplement daily (\\~27 days)', 'interventionNames': ['Dietary Supplement: Protein, High-Protein, and Control']}], 'interventions': [{'name': 'Protein, High-Protein, and Control', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Whey and Casein protein', 'Carbohydrate-based control'], 'armGroupLabels': ['Control', 'High-Protein', 'Protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28546', 'city': 'Marine Corps Base Camp Lejeune', 'state': 'North Carolina', 'country': 'United States', 'facility': 'US Marine SERE School', 'geoPoint': {'lat': 34.58769, 'lon': -77.39259}}], 'overallOfficials': [{'name': 'Stefan M Pasiakos, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USARIEM Military Nutrition Division'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Army Research Institute of Environmental Medicine', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}