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Clinical Trials/NCT01292395
NCT01292395
Completed
Not Applicable

The Musculoskeletal Response to Energy Deficit: Defining Optimal Protein Intake

United States Army Research Institute of Environmental Medicine1 site in 1 country42 target enrollmentSeptember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Weight Loss
Sponsor
United States Army Research Institute of Environmental Medicine
Enrollment
42
Locations
1
Primary Endpoint
Change from weight maintenance in muscle metabolism after energy restriction
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
November 2011
Last Updated
8 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
United States Army Research Institute of Environmental Medicine
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change from weight maintenance in muscle metabolism after energy restriction

Time Frame: Measured after a 3 week energy deficit

Secondary Outcomes

  • Change from weight maintenance in bone metabolism after energy restriction(Measured after a 3 week energy deficit)

Study Sites (1)

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