Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT05210205
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2021-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physiological Response to Protein and Energy-enhanced Food Products During Winter 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2022-01-25', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Protein balance', 'timeFrame': '10 hours', 'description': 'Use stable isotope methodologies to measure whole-body protein balance'}, {'measure': 'Energy Expenditure', 'timeFrame': '8 days', 'description': 'Use stable isotope methodologies to measure energy expenditure during the training exercise.'}, {'measure': 'Energy intake', 'timeFrame': '8 days', 'description': 'Use food logs and collect food wrappers to measure energy intake during the training exercise.'}], 'secondaryOutcomes': [{'measure': 'Intestinal Permeability', 'timeFrame': '24 hours', 'description': 'Use dual sugar test (i.e., sucralose and erythritol) to measure intestinal permeability'}, {'measure': 'Gut microbiome composition', 'timeFrame': 'Study days -1 and 9', 'description': 'Measure changes in fecal bacterial community, diversity, and relative abundance'}, {'measure': 'Vertical jump', 'timeFrame': 'Study day 0 and 9', 'description': 'Measure changes in physical performance as determined by a vertical jump test'}, {'measure': 'Pull Strength Test', 'timeFrame': 'Study day 0 and 9', 'description': 'Measure changes in physical performance as determined by a pull strength test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Military Operational Stress Reaction', 'Malnutrition (Calorie)', 'Weight Loss', 'Muscle Wasting']}, 'descriptionModule': {'briefSummary': 'Soldiers commonly lose muscle mass during training and combat operations that produce large energy deficits (i.e., calories burned \\> calories consumed). Developing new combat ration products that increase energy intake (i.e., energy dense foods) or the amount and quality of protein consumed (i.e., essential amino acid \\[EAA\\] content) may prevent muscle breakdown and stimulate muscle repair and muscle maintenance during unavoidable energy deficit. The primary objective of this study is to determine the effects of prototype recovery food products that are energy dense or that provide increased amounts of EAAs (anabolic component of dietary protein) on energy balance, whole-body net protein balance, and indices of physiological status during strenuous winter military training.', 'detailedDescription': 'Up to 96 Norwegian Soldiers participating in a winter training exercise at the Garrison in Sør-Varanger (GSV) will be enrolled in an approximately 11-day, randomized controlled study. Participants will be randomly assigned at the beginning of the training exercise to groups provided 3 Norwegian Army arctic combat rations and approximately 1500 supplemental calories from food products with increased energy density (EN-DENSE), increased essential amino acids (EAA), or low energy density (CONTROL) each day. Participants will be instructed to consume all of the supplemental food products provided to them and consume the arctic combat rations ad libitum. The effect of consuming EN-DENSE, EAA, or CONTROL food products during strenuous military training on physiological status and recovery will be assessed using dietary analysis, stable isotope methodologies, physical performance measures, gut health analyses, blood sampling, and questionnaires. This design will test the hypothesis that 1) EN-DENSE ration products will attenuate the energy deficit during the training, thereby limiting whole-body protein losses and decrements in physiological status; and 2) the protein-sparing benefit of EAA will limit whole-body protein loss regardless of the energy deficit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale and female Norwegian Soldiers aged 18 years or older participating in the winter training exercise at the Garrison in Sør-Varanger.\n\nExclusion Criteria:\n\n* Any injury or health condition limiting full participation in the training program.\n* Allergies or intolerance to foods used in the study (including but not limited to lactose intolerance/milk allergy) or vegetarian practices.'}, 'identificationModule': {'nctId': 'NCT05210205', 'briefTitle': 'Physiological Response to Protein and Energy-enhanced Food Products During Winter Military Training', 'organization': {'class': 'FED', 'fullName': 'United States Army Research Institute of Environmental Medicine'}, 'officialTitle': 'Physiological Efficacy and Acceptability of Essential Amino Acid-enhanced and Energy Density-enhanced Combat Ration Products During Multi-stressor Operations', 'orgStudyIdInfo': {'id': '21-19HC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EAA-enhanced food products', 'description': 'Consume approximately 1500 calories of EAA-enhanced food products plus ad libitum consumption of 3 combat rations each day during training.', 'interventionNames': ['Dietary Supplement: EAA']}, {'type': 'EXPERIMENTAL', 'label': 'Energy dense food products', 'description': 'Consume approximately 1500 calories of energy dense food products plus ad libitum consumption of 3 combat rations each day during training.', 'interventionNames': ['Dietary Supplement: Energy Dense']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control food products', 'description': 'Consume approximately 1500 calories of low energy dense food products plus ad libitum consumption of 3 combat rations each day during training.', 'interventionNames': ['Dietary Supplement: Control']}], 'interventions': [{'name': 'EAA', 'type': 'DIETARY_SUPPLEMENT', 'description': 'EAA-enhanced protein snack bars', 'armGroupLabels': ['EAA-enhanced food products']}, {'name': 'Energy Dense', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Energy dense snack bars (same calories in a smaller volume of food)', 'armGroupLabels': ['Energy dense food products']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Low energy dense snack bars (same calories in a greater volume of food)', 'armGroupLabels': ['Control food products']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kirkenes', 'country': 'Norway', 'facility': 'Garrison in Sør-Varanger', 'geoPoint': {'lat': 69.72706, 'lon': 30.04578}}], 'overallOfficials': [{'name': 'Emily E Howard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'United States Army Research Institute of Environmental Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Army Research Institute of Environmental Medicine', 'class': 'FED'}, 'collaborators': [{'name': 'Norwegian Defense Research Establishment', 'class': 'UNKNOWN'}, {'name': 'University of Arkansas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}