Combined Effects of Nutritional and Exercise Countermeasures

Study Overview
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Brief Summary
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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.

Official Title
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Combined Effects of Nutritional and Exercise Countermeasures

Conditions
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Muscular Atrophy, Muscle Weakness

Intervention / Treatment
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* Behavioral: Resistance Exercise
* Dietary Supplement: diet orange soda
* Dietary Supplement: essential amino acids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>Subjects drink essential amino acid supplement 3x day for 2 days. | Dietary Supplement: essential amino acids<br>* Subjects drink 15 grams of EAA mixed into diet orange soda 3x day for 2 days.<br>|
| Placebo Comparator: 1<br>Subjects receive inert substance versus protein supplement. | Dietary Supplement: diet orange soda<br>* Subjects drink diet orange soda 3x day for 2 days.<br>|
| Experimental: 3<br>Resistance exercise. | Behavioral: Resistance Exercise<br>* Subjects will lift weights with their legs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional synthetic rate of muscle growth. |  | two days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle loss and Maintenance of Muscle function