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Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency

This study has been completed.
Sponsor:
Collaborators:
USDA Grand Forks Human Nutrition Research Center
Eastern Michigan University
Information provided by (Responsible Party):
United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier:
NCT01292395
First received: January 19, 2011
Last updated: December 5, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by United States Army Research Institute of Environmental Medicine:

Primary Outcome Measures:
  • Change from weight maintenance in muscle metabolism after energy restriction [ Time Frame: Measured after a 3 week energy deficit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292395

Locations
United States, North Dakota
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, United States, 58202
Sponsors and Collaborators
United States Army Research Institute of Environmental Medicine
USDA Grand Forks Human Nutrition Research Center
Eastern Michigan University
Investigators
Principal Investigator: Stefan M Pasiakos, PhD United States Army Research Institute of Environmental Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: December 5, 2013
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
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014