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Muscle Mass During Space Exploration

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ClinicalTrials.gov Identifier: NCT00968344
Recruitment Status : Completed
First Posted : August 31, 2009
Last Update Posted : May 28, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The investigators will test the following hypotheses:

  1. Bedrest will blunt the anabolic response to a mixed nutrient meal, facilitating a loss of muscle mass and functional capacity that is only partially restored during rehabilitation.
  2. Enriching daily meals with leucine will promote protein synthesis and maintain the anabolic response to mixed nutrient meal ingestion. This will preserve lean muscle mass and function during bedrest and facilitate the recovery of functional and metabolic capacity during rehabilitation.

Condition or disease Intervention/treatment Phase
Muscle Loss Dietary Supplement: Leucine Phase 3

Detailed Description:

Our long-term goal is to identify, prevent and remedy defects in the metabolic pathway that contribute to the loss of muscle mass and function during exposure to microgravity. Demographic data indicate that the average age of shuttle crew members has increased from 40.7 yrs in 1995 to 46.7 yrs in 2007 with an increasing number of astronauts over 50 yrs of age. We contend that the loss of muscle mass and function during spaceflight is facilitated by an age-associated, progressive impairment in the ability to mount an anabolic response to standard mixed nutrient meals. We propose that enriching daily meals with a low-volume leucine supplement will reduce the deleterious effects of microgravity on skeletal muscle and facilitate recovery during rehabilitation.

We will employ our established 14 day bed rest protocol to model the skeletal muscle unloading that occurs during microgravity. We will also examine recovery of muscle mass and functional capacity during a 7 day rehabilitation period. We will study 2 groups: CON (Bedrest/Recovery + Placebo; n=15), LEU (Bedrest/Recovery + Leucine; n=15). We will assess a) markers of translation initiation, b) muscle protein synthesis, c) muscle mass and body composition and d) strength and aerobic capacity.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: An Integrated Low-Volume Nutritional Countermeasure to Maintain Muscle Mass and Function During Space Exploration
Study Start Date : August 2009
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Leucine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Leucine Dietary Supplement: Leucine
3-4g Leucine added to daily meals
Placebo Comparator: Placebo Dietary Supplement: Leucine
Powered amino acid
Other Name: Alanine


Outcome Measures

Primary Outcome Measures :
  1. Muscle protein synthesis [ Time Frame: 4 yrs ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age between 45-60
  2. Ability to sign informed consent

Exclusion Criteria:

  1. Subjects with cardiac abnormalities considered exclusionary by the study physicians
  2. Subjects with uncontrolled metabolic disease
  3. A GFR <65 mL/min/1.73m2 or evidence of kidney disease or failure
  4. Subjects with vascular disease or risk factors of peripheral atherosclerosis
  5. Any history of hypo- or hyper-coagulation disorders. (e.g., Coumadin use or history of DVT or PE)
  6. Subjects with chronically elevated systolic pressure >150 or a diastolic blood pressure > 100
  7. Subjects with implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
  8. Subjects with recently (6 months) treated cancer other than basal cell carcinoma
  9. Any subject currently on a weight-loss diet or a body mass index > 30 kg/m2
  10. Inability to abstain from smoking for duration of study
  11. A history of > 20 pack per year smoking
  12. Any subject that is HIV-seropositive or has active hepatitis
  13. Recent anabolic or corticosteroids use (within 3 months)
  14. Subjects with hemoglobin or hematocrit lower than accepted lab values
  15. Agitation/aggression disorder
  16. History of stroke with motor disability
  17. A recent history (<12 months) of GI bleed
  18. Any other condition or event considered exclusionary by the PI and faculty physician
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968344


Locations
United States, Texas
The University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
National Space Biomedical Research Institute
Investigators
Principal Investigator: Douglas Paddon-Jones, PhD The University of Texas Medical Branch at Galveston
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00968344     History of Changes
Other Study ID Numbers: 09-121
MA02001
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015