- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01292395
Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency
August 10, 2017 updated by: United States Army Research Institute of Environmental Medicine
The Musculoskeletal Response to Energy Deficit: Defining Optimal Protein Intake
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Dakota
-
Grand Forks, North Dakota, United States, 58202
- USDA Grand Forks Human Nutrition Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 42 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Weight stable with body mass index 22-29 kg/m2
- Physically active
- Refrain from NSAIDS and other aspirin containing medications
- Refrain from alcohol and nicotine
Exclusion Criteria:
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders
- Disease or medication that affects metabolism and/or exercise
- Allergies or intolerance to foods, vegetarian practices, or medications to be used in the study
- Anemia and Sickle Cell Anemia/Trait; abnormal PT/PTT test or problems with blood clotting
- Present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues
- Musculoskeletal injuries that compromise the ability to exercise
- Blood donation within 8 weeks of beginning the study
- Pregnancy and women not on contraceptives
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Protein level 1
|
Protein intakes within the current recommendation
|
Experimental: Protein level 2
|
Protein intakes within the current recommendation
|
Experimental: Protein level 3
|
Protein intakes within the current recommendation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from weight maintenance in muscle metabolism after energy restriction
Time Frame: Measured after a 3 week energy deficit
|
Measured after a 3 week energy deficit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from weight maintenance in bone metabolism after energy restriction
Time Frame: Measured after a 3 week energy deficit
|
Measured after a 3 week energy deficit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stefan M Pasiakos, PhD, United States Army Research Institute of Environmental Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
January 19, 2011
First Submitted That Met QC Criteria
February 7, 2011
First Posted (Estimate)
February 9, 2011
Study Record Updates
Last Update Posted (Actual)
August 14, 2017
Last Update Submitted That Met QC Criteria
August 10, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H10-03
- 503 (Other Identifier: USDA GFHNRC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Weight Loss
-
Case Comprehensive Cancer CenterUniversity Hospitals Seidman Cancer CenterRecruitingUnintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking CombinUnintended Weight LossUnited States
-
Zhen Jun WangUnknownSleeve Gastrectomy | Excessive Weight Loss | Total Weight Loss | Jejunojejunal Bypass | UncutChina
-
HealthPartners InstituteNational Cancer Institute (NCI)Completed
-
Dana-Farber Cancer InstituteCompletedWeight Loss Program After Cancer DiagnosisUnited States
-
Medical University of ViennaCompleted
-
University at BuffaloHarvard Medical School (HMS and HSDM)TerminatedWeight Loss | Appetite LossUnited States
-
Power Life Sciences Inc.Not yet recruitingGastric Bypass | Weight Loss Surgery
-
Duke UniversityNational Institute on Aging (NIA)Suspended
-
University of AarhusToyota-Fonden; Orkla Health; Tømmerhandler Vilhelm Bangs FondCompletedMuscle Loss
-
Drexel UniversityUniversity of PennsylvaniaCompletedObesity | Overweight | Weight Loss MaintenanceUnited States
Clinical Trials on Dietary Protein Intake
-
University of CopenhagenMaastricht University Medical CenterRecruitingDiet, Healthy | Protein DeficiencyDenmark
-
University of ArkansasCompletedSarcopeniaUnited States
-
King Saud Bin Abdulaziz University for Health SciencesCompleted
-
University of TorontoCompletedProtein/Amino Acid Metabolism | Indicator Amino Acid Oxidation MethodCanada
-
Anglia Ruskin UniversityUniversity of ExeterCompletedMuscle Soreness | Protein-energy; ImbalanceUnited Kingdom
-
University of ArkansasDairy Research InstituteCompletedMetabolic Syndrome
-
Purdue UniversityAmerican Egg BoardCompletedIngestive Behavior | Brain Activity | Appetite | Cholesterol | Glucose ControlUnited States
-
Arkansas Children's Hospital Research InstituteRecruiting
-
University of ArkansasCompleted