Combined Effects of Nutritional and Exercise Countermeasures

University of Arkansas

Status: Completed

Conditions: Muscle Weakness; Muscular Atrophy

Treatments: Dietary Supplement: essential amino acids; Behavioral: Resistance Exercise; Dietary Supplement: diet orange soda

Study type: Interventional

Funder types: Other

Identifiers

NCT00447044

72779

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 3 patient groups, including a placebo group

2

Experimental group

Description:

Subjects drink essential amino acid supplement 3x day for 2 days.

Treatment:

Dietary Supplement: essential amino acids

1

Placebo Comparator group

Description:

Subjects receive inert substance versus protein supplement.

Treatment:

Dietary Supplement: diet orange soda

3

Experimental group

Description:

Resistance exercise.

Treatment:

Behavioral: Resistance Exercise