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CompletedNCT01292395Updated Aug 14, 2017

Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency

An interventional study of Dietary Protein Intake in Weight Loss, Muscle Loss and Bone Loss, sponsored by United States Army Research Institute of Environmental Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-14.

Sponsored by United States Army Research Institute of Environmental Medicine · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 42 Years
Sex
All
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Study 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.

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Conditions studied

  • Weight Loss
  • Muscle Loss
  • Bone Loss

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Keywords

  • dietary supplement
  • protein metabolism
  • bone turnover
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In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's enrollment of 42 is below the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

United States Army Research Institute of Environmental Medicine is the lead sponsor of 67 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Protein level 1

    Other: Dietary Protein Intake

  • Experimental
    Protein level 2

    Other: Dietary Protein Intake

  • Experimental
    Protein level 3

    Other: Dietary Protein Intake

Interventions

  • OtherDietary Protein Intake

    Protein intakes within the current recommendation

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What researchers measure

Primary outcomes

  1. Change from weight maintenance in muscle metabolism after energy restriction

    Time frame: Measured after a 3 week energy deficit

Secondary outcomes

  1. Change from weight maintenance in bone metabolism after energy restriction

    Time frame: Measured after a 3 week energy deficit

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Study locations

1 site
  • USDA Grand Forks Human Nutrition Research Center
    Grand Forks, North Dakota 58202, United States
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References and documents

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. PubMed 22516719 ↗
  • 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. PubMed 24284444 ↗
  • 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. PubMed 24166063 ↗
  • 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. PubMed 23965841 ↗
  • 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. PubMed 23739654 ↗
  • 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. PubMed 25479571 ↗
  • 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. PubMed 24641883 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01292395
Lead sponsor
United States Army Research Institute of Environmental Medicine
Collaborators
USDA Grand Forks Human Nutrition Research Center, Eastern Michigan University
Responsible party
Sponsor
First posted
Feb 9, 2011
Start date
Sep 2010
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Aug 14, 2017

Study contacts

Stefan M Pasiakos, PhD
principal investigator · United States Army Research Institute of Environmental Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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