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OpenTrials
Completed

NCT Number: NCT01292395

Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency

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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Key information

Conditions

Weight Loss Atrophy Body Weight Body Weight Changes Bone Diseases Bone Diseases, Metabolic Bone Loss Metabolic Diseases Muscle Loss Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–42 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Protein Intake

Other

Protein intakes within the current recommendation

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

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Collaborators

  • Eastern Michigan University
  • USDA Grand Forks Human Nutrition Research Center

Registry information

Official study title

The Musculoskeletal Response to Energy Deficit: Defining Optimal Protein Intake

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 9, 2011
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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