Muscle Mass During Space Exploration

Completed · Not applicable · Has a placebo group

Conditions studied: Muscle Loss

In brief

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.

Key facts

Study ID

NCT00968344

Run by

The University of Texas Medical Branch, Galveston

People needed

40

Starts

2009-08-01

Expected to finish

2015-04-01

Last updated by the study team

2019-05-31

Who can join

Age: 45 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age between 45-60
• Ability to sign informed consent

You may not qualify if…

• 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

Where it is running

• The University of Texas Medical Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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