Clinical trial NCT00447044: Combined Effects of Nutritional and Exercise Countermeasures
Official title: Combined Effects of Nutritional and Exercise Countermeasures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Atrophy
Muscle Weakness
Keywords: Muscle loss and Maintenance of Muscle function
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2007-03-13
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see if a combination of resistance exercises and amino acid capsules can reduce muscle loss and maintain muscle function during bedrest. This experiment will imitate many of the physical conditions experienced by astronauts during space flight by examining the effects of resistance exercise or nutrition on muscle during 2 days of bedrest. The diet of astronauts will also be imitated by providing diets in the General Clinic Research Center.


Eligibility criteria: Inclusion Criteria:

* 18-50 years of age
* Availability of transport and ability to report to Research Center at appointed times

Exclusion Criteria:

* Subjects with limiting or unstable angina or a cardiology confirmed ECG which demonstrates cardiac abnormalities such as \> 0.2 mV horizontal or downsloping ST segment depression, frequent arrhythmia's (\>10 PVC/min), or valvular disease.
* Subjects with vascular disease as determined by a combination of risk factors of peripheral atherosclerosis, namely hypertension, obesity, diabetes, hypercholesterolemia and/or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal, and pedal arteries.
* Any history of hypo- or hyper-coagulation disorders including subjects taking Coumadin or with a history of DVT or PE at any point in their lifetime.
* Any subject that has a chronically elevated systolic pressure \>170 or a diastolic blood pressure \> 100 will be excluded. Subjects may be included if they are taking blood pressure medication and have a blood pressure below these criteria.
* Any subject with an uncontrolled metabolic disease including liver or renal disease.
* Fasting blood glucose of \>126 mg/dl on two separate occasions
* Presence of acute illness or metabolically unstable chronic illness.
* Any subject currently on weight-loss diet.
* Inability to abstain from smoking for duration of study.
* Recent ingestion of anabolic steroids (within 6 months).
* Subjects with atrial fibrillation, history of syncope, angina or congestive heart failure.
* Subjects with a recently (6 months) treated cancer other than Basal Cell Carcinoma.
* Pregnancy/lactation.
* Any other condition or event considered exclusionary by the PI and covering faculty

Primary outcomes:
measure: Fractional synthetic rate of muscle growth.
timeFrame: two days.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Arny Ferrando, PhD
role: PRINCIPAL_INVESTIGATOR
References: