Combined Effects of Nutritional and Exercise Countermeasures

Muscle Weakness Clinical Trial

Official title:

Combined Effects of Nutritional and Exercise Countermeasures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447044
• Other study ID #: 72779
• Status: Completed
• Phase: N/A
• First received: March 12, 2007
• Last updated: June 17, 2009
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Muscle Weakness
• Muscular Atrophy
• Paresis

Intervention

Behavioral:
• Resistance Exercise
Subjects will lift weights with their legs.

Dietary Supplement:
• diet orange soda
Subjects drink diet orange soda 3x day for 2 days.
• essential amino acids
Subjects drink 15 grams of EAA mixed into diet orange soda 3x day for 2 days.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional synthetic rate of muscle growth.		two days.	No