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Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency

The Musculoskeletal Response to Energy Deficit: Defining Optimal Protein Intake

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01292395
Enrollment
42
Registered
2011-02-09
Start date
2010-09-30
Completion date
2011-11-30
Last updated
2017-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Loss, Muscle Loss, Weight Loss

Keywords

dietary supplement, protein metabolism, bone turnover

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.

Interventions

Protein intakes within the current recommendation

Sponsors

USDA Grand Forks Human Nutrition Research Center
CollaboratorFED
Eastern Michigan University
CollaboratorOTHER
United States Army Research Institute of Environmental Medicine
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 42 Years
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

* 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

Design outcomes

Primary

MeasureTime frame
Change from weight maintenance in muscle metabolism after energy restrictionMeasured after a 3 week energy deficit

Secondary

MeasureTime frame
Change from weight maintenance in bone metabolism after energy restrictionMeasured after a 3 week energy deficit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026