Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Weight Loss Muscle Loss Bone Loss |
Other: Dietary Protein Intake |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | The Musculoskeletal Response to Energy Deficit: Defining Optimal Protein Intake |
- Change from weight maintenance in muscle metabolism after energy restriction [ Time Frame: Measured after a 3 week energy deficit ] [ Designated as safety issue: No ]
- Change from weight maintenance in bone metabolism after energy restriction [ Time Frame: Measured after a 3 week energy deficit ] [ Designated as safety issue: No ]
| Enrollment: | 42 |
| Study Start Date: | September 2010 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Protein level 1 |
Other: Dietary Protein Intake
Protein intakes within the current recommendation
|
| Experimental: Protein level 2 |
Other: Dietary Protein Intake
Protein intakes within the current recommendation
|
| Experimental: Protein level 3 |
Other: Dietary Protein Intake
Protein intakes within the current recommendation
|
Eligibility| Ages Eligible for Study: | 18 Years to 42 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, North Dakota | |
| USDA Grand Forks Human Nutrition Research Center | |
| Grand Forks, North Dakota, United States, 58202 | |
| Principal Investigator: | Stefan M Pasiakos, PhD | United States Army Research Institute of Environmental Medicine |
More Information
No publications provided
| Responsible Party: | United States Army Research Institute of Environmental Medicine |
| ClinicalTrials.gov Identifier: | NCT01292395 History of Changes |
| Other Study ID Numbers: | H10-03, 502 |
| Study First Received: | January 19, 2011 |
| Last Updated: | October 23, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by United States Army Research Institute of Environmental Medicine:
|
dietary supplement protein metabolism bone turnover |
Additional relevant MeSH terms:
|
Weight Loss Body Weight Changes Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013