Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency

United States Army Research Institute of Environmental Medicine

Status: Completed

Conditions: Weight Loss; Muscle Loss; Bone Loss

Treatments: Other: Dietary Protein Intake

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01292395

503

H10-03

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Protein level 1

Experimental group

Treatment:

Other: Dietary Protein Intake

Protein level 2

Experimental group

Treatment:

Other: Dietary Protein Intake

Protein level 3

Experimental group

Treatment:

Other: Dietary Protein Intake