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Combined Effects of Nutritional and Exercise Countermeasures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00447044
Recruitment Status : Completed
First Posted : March 13, 2007
Last Update Posted : June 19, 2009
Information provided by:
University of Arkansas

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.

Condition or disease Intervention/treatment
Muscular Atrophy Muscle Weakness Behavioral: Resistance Exercise Dietary Supplement: diet orange soda Dietary Supplement: essential amino acids

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Combined Effects of Nutritional and Exercise Countermeasures
Study Start Date : January 2007
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Fractional synthetic rate of muscle growth. [ Time Frame: two days. ]

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00447044

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Principal Investigator: Arny Ferrando, PhD University of Arkansas

Responsible Party: Arny A. Ferrando, PhD, UAMS Identifier: NCT00447044     History of Changes
Other Study ID Numbers: 72779
First Posted: March 13, 2007    Key Record Dates
Last Update Posted: June 19, 2009
Last Verified: June 2009

Keywords provided by University of Arkansas:
Muscle loss and Maintenance of Muscle function

Additional relevant MeSH terms:
Muscular Atrophy
Muscle Weakness
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Pathologic Processes