Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency

Weight Loss Clinical Trial

Official title:

The Musculoskeletal Response to Energy Deficit: Defining Optimal Protein Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292395
• Other study ID #: H10-03
• Secondary ID: 503
• Status: Completed
• Phase: N/A
• First received: January 19, 2011
• Last updated: August 10, 2017
• Start date: September 2010
• Est. completion date: November 2011

Study information

• Verified date: August 2017
• Source: United States Army Research Institute of Environmental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Loss
• Muscle Loss
• Weight Loss

Intervention

Other:
• Dietary Protein Intake
Protein intakes within the current recommendation

Locations

Country	Name	City	State
United States	USDA Grand Forks Human Nutrition Research Center	Grand Forks	North Dakota

Sponsors (3)

Lead Sponsor	Collaborator
United States Army Research Institute of Environmental Medicine	Eastern Michigan University, USDA Grand Forks Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 — View 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. do — View 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. Review. — View 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. 201 — View 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/i — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from weight maintenance in muscle metabolism after energy restriction		Measured after a 3 week energy deficit
Secondary	Change from weight maintenance in bone metabolism after energy restriction		Measured after a 3 week energy deficit