Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-30 @ 4:54 AM
Study NCT ID:
NCT01292395
Status:
COMPLETED
Last Update Posted:
2017-08-14
First Post:
2011-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'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'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-10', 'studyFirstSubmitDate': '2011-01-19', 'studyFirstSubmitQcDate': '2011-02-07', 'lastUpdatePostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from weight maintenance in muscle metabolism after energy restriction', 'timeFrame': 'Measured after a 3 week energy deficit'}], 'secondaryOutcomes': [{'measure': 'Change from weight maintenance in bone metabolism after energy restriction', 'timeFrame': 'Measured after a 3 week energy deficit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dietary supplement', 'protein metabolism', 'bone turnover'], 'conditions': ['Weight Loss', 'Muscle Loss', 'Bone Loss']}, 'referencesModule': {'references': [{'pmid': '22516719', 'type': 'BACKGROUND', 'citation': 'Carbone JW, McClung JP, Pasiakos SM. Skeletal muscle responses to negative energy balance: effects of dietary protein. Adv Nutr. 2012 Mar 1;3(2):119-26. doi: 10.3945/an.111.001792.'}, {'pmid': '24284444', 'type': 'RESULT', 'citation': 'Cao JJ, Pasiakos SM, Margolis LM, Sauter ER, Whigham LD, McClung JP, Young AJ, Combs GF Jr. Calcium homeostasis and bone metabolic responses to high-protein diets during energy deficit in healthy young adults: a randomized controlled trial. Am J Clin Nutr. 2014 Feb;99(2):400-7. doi: 10.3945/ajcn.113.073809. Epub 2013 Nov 27.'}, {'pmid': '24166063', 'type': 'RESULT', 'citation': 'Pasiakos SM, Margolis LM, McClung JP, Cao JJ, Whigham LD, Combs GF, Young AJ. Whole-body protein turnover response to short-term high-protein diets during weight loss: a randomized controlled trial. Int J Obes (Lond). 2014 Jul;38(7):1015-8. doi: 10.1038/ijo.2013.197. Epub 2013 Oct 29.'}, {'pmid': '23965841', 'type': 'RESULT', 'citation': 'Carbone JW, Margolis LM, McClung JP, Cao JJ, Murphy NE, Sauter ER, Combs GF Jr, Young AJ, Pasiakos SM. Effects of energy deficit, dietary protein, and feeding on intracellular regulators of skeletal muscle proteolysis. FASEB J. 2013 Dec;27(12):5104-11. doi: 10.1096/fj.13-239228. Epub 2013 Aug 21.'}, {'pmid': '23739654', 'type': 'RESULT', 'citation': 'Pasiakos SM, Cao JJ, Margolis LM, Sauter ER, Whigham LD, McClung JP, Rood JC, Carbone JW, Combs GF Jr, Young AJ. Effects of high-protein diets on fat-free mass and muscle protein synthesis following weight loss: a randomized controlled trial. FASEB J. 2013 Sep;27(9):3837-47. doi: 10.1096/fj.13-230227. Epub 2013 Jun 5.'}, {'pmid': '25479571', 'type': 'DERIVED', 'citation': 'Karl JP, Thompson LA, Niro PJ, Margolis LM, McClung JP, Cao JJ, Whigham LD, Combs GF Jr, Young AJ, Lieberman HR, Pasiakos SM. Transient decrements in mood during energy deficit are independent of dietary protein-to-carbohydrate ratio. Physiol Behav. 2015 Feb;139:524-31. doi: 10.1016/j.physbeh.2014.11.068. Epub 2014 Dec 3.'}, {'pmid': '24641883', 'type': 'DERIVED', 'citation': 'Henning PC, Margolis LM, McClung JP, Young AJ, Pasiakos SM. High protein diets do not attenuate decrements in testosterone and IGF-I during energy deficit. Metabolism. 2014 May;63(5):628-32. doi: 10.1016/j.metabol.2014.02.007. Epub 2014 Feb 17.'}]}, 'descriptionModule': {'briefSummary': 'Military personnel face many physiological challenges, including sustained physical activity and prolonged periods of negative energy balance. Chronic energy deficiency often results in a loss of skeletal muscle mass and can reduce overall bone health. Recent evidence suggests that dietary interventions that provide protein in excess of the current national dietary recommendation may confer protection against the negative effects of energy deficiency on the musculoskeletal system. The primary objective of this randomized, controlled study is to assess the effects dietary protein intake spanning the current acceptable macronutrient distribution range on musculoskeletal health following prolonged energy deficiency. Findings from this investigation will improve current understanding of dietary conditions necessary to reduce the damaging effects of caloric deficiency on musculoskeletal health in warfighters. Furthermore, given the rise in obesity in military populations, findings may aid in the development of nutritional weight management strategies that promote healthy weight loss without compromising musculoskeletal health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight stable with body mass index 22-29 kg/m2\n* Physically active\n* Refrain from NSAIDS and other aspirin containing medications\n* Refrain from alcohol and nicotine\n\nExclusion Criteria:\n\n* Metabolic or cardiovascular abnormalities, gastrointestinal disorders\n* Disease or medication that affects metabolism and/or exercise\n* Allergies or intolerance to foods, vegetarian practices, or medications to be used in the study\n* Anemia and Sickle Cell Anemia/Trait; abnormal PT/PTT test or problems with blood clotting\n* Present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues\n* Musculoskeletal injuries that compromise the ability to exercise\n* Blood donation within 8 weeks of beginning the study\n* Pregnancy and women not on contraceptives'}, 'identificationModule': {'nctId': 'NCT01292395', 'briefTitle': 'Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency', 'organization': {'class': 'FED', 'fullName': 'United States Army Research Institute of Environmental Medicine'}, 'officialTitle': 'The Musculoskeletal Response to Energy Deficit: Defining Optimal Protein Intake', 'orgStudyIdInfo': {'id': 'H10-03'}, 'secondaryIdInfos': [{'id': '503', 'type': 'OTHER', 'domain': 'USDA GFHNRC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protein level 1', 'interventionNames': ['Other: Dietary Protein Intake']}, {'type': 'EXPERIMENTAL', 'label': 'Protein level 2', 'interventionNames': ['Other: Dietary Protein Intake']}, {'type': 'EXPERIMENTAL', 'label': 'Protein level 3', 'interventionNames': ['Other: Dietary Protein Intake']}], 'interventions': [{'name': 'Dietary Protein Intake', 'type': 'OTHER', 'description': 'Protein intakes within the current recommendation', 'armGroupLabels': ['Protein level 1', 'Protein level 2', 'Protein level 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58202', 'city': 'Grand Forks', 'state': 'North Dakota', 'country': 'United States', 'facility': 'USDA Grand Forks Human Nutrition Research Center', 'geoPoint': {'lat': 47.92526, 'lon': -97.03285}}], 'overallOfficials': [{'name': 'Stefan M Pasiakos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'United States Army Research Institute of Environmental Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Army Research Institute of Environmental Medicine', 'class': 'FED'}, 'collaborators': [{'name': 'USDA Grand Forks Human Nutrition Research Center', 'class': 'FED'}, {'name': 'Eastern Michigan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}