Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency
Primary Purpose
Weight Loss, Muscle Loss, Bone Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Protein Intake
Sponsored by

About this trial
This is an interventional basic science trial for Weight Loss focused on measuring dietary supplement, protein metabolism, bone turnover
Eligibility Criteria
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
Sites / Locations
- USDA Grand Forks Human Nutrition Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Protein level 1
Protein level 2
Protein level 3
Arm Description
Outcomes
Primary Outcome Measures
Change from weight maintenance in muscle metabolism after energy restriction
Secondary Outcome Measures
Change from weight maintenance in bone metabolism after energy restriction
Full Information
NCT ID
NCT01292395
First Posted
January 19, 2011
Last Updated
August 10, 2017
Sponsor
United States Army Research Institute of Environmental Medicine
Collaborators
USDA Grand Forks Human Nutrition Research Center, Eastern Michigan University
1. Study Identification
Unique Protocol Identification Number
NCT01292395
Brief Title
Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency
Official Title
The Musculoskeletal Response to Energy Deficit: Defining Optimal Protein Intake
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Army Research Institute of Environmental Medicine
Collaborators
USDA Grand Forks Human Nutrition Research Center, Eastern Michigan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Muscle Loss, Bone Loss
Keywords
dietary supplement, protein metabolism, bone turnover
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Protein level 1
Arm Type
Experimental
Arm Title
Protein level 2
Arm Type
Experimental
Arm Title
Protein level 3
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Dietary Protein Intake
Intervention Description
Protein intakes within the current recommendation
Primary Outcome Measure Information:
Title
Change from weight maintenance in muscle metabolism after energy restriction
Time Frame
Measured after a 3 week energy deficit
Secondary Outcome Measure Information:
Title
Change from weight maintenance in bone metabolism after energy restriction
Time Frame
Measured after a 3 week energy deficit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan M Pasiakos, PhD
Organizational Affiliation
United States Army Research Institute of Environmental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Grand Forks Human Nutrition Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22516719
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.
Results Reference
background
PubMed Identifier
24284444
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.
Results Reference
result
PubMed Identifier
24166063
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.
Results Reference
result
PubMed Identifier
23965841
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.
Results Reference
result
PubMed Identifier
23739654
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.
Results Reference
result
PubMed Identifier
25479571
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.
Results Reference
derived
PubMed Identifier
24641883
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.
Results Reference
derived
Learn more about this trial
Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency
We'll reach out to this number within 24 hrs