- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00968344
Muscle Mass During Space Exploration
An Integrated Low-Volume Nutritional Countermeasure to Maintain Muscle Mass and Function During Space Exploration
The investigators will test the following hypotheses:
- 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.
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Galveston, Texas, United States, 77555
- The University of Texas Medical Branch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 45-60
- Ability to sign informed consent
Exclusion Criteria:
- Subjects with cardiac abnormalities considered exclusionary by the study physicians
- Subjects with uncontrolled metabolic disease
- A GFR <65 mL/min/1.73m2 or evidence of kidney disease or failure
- Subjects with vascular disease or risk factors of peripheral atherosclerosis
- Any history of hypo- or hyper-coagulation disorders. (e.g., Coumadin use or history of DVT or PE)
- Subjects with chronically elevated systolic pressure >150 or a diastolic blood pressure > 100
- Subjects with implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
- Subjects with recently (6 months) treated cancer other than basal cell carcinoma
- Any subject currently on a weight-loss diet or a body mass index > 30 kg/m2
- Inability to abstain from smoking for duration of study
- A history of > 20 pack per year smoking
- Any subject that is HIV-seropositive or has active hepatitis
- Recent anabolic or corticosteroids use (within 3 months)
- Subjects with hemoglobin or hematocrit lower than accepted lab values
- Agitation/aggression disorder
- History of stroke with motor disability
- A recent history (<12 months) of GI bleed
- Any other condition or event considered exclusionary by the PI and faculty physician
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Leucine
3-4 g Leucine added to daily meals during bed rest
|
3-4g Leucine added to daily meals
|
Placebo Comparator: Placebo
3-4 g Alanine added to daily meals during bed rest
|
Powered amino acid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lean Leg Mass
Time Frame: At baseline prior to beginning bed rest and after 14 days of bed rest
|
DEXA scan of both legs pre/post bed rest
|
At baseline prior to beginning bed rest and after 14 days of bed rest
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Douglas Paddon-Jones, PhD, The University of Texas Medical Branch at Galveston
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 09-121
- MA02001 (Other Grant/Funding Number: NSBRI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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