Combined Effects of Nutritional and Exercise Countermeasures - Full Text View

Sponsored by:	University of Arkansas
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00447044

Purpose

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	Intervention
Muscular Atrophy Muscle Weakness	Behavioral: Resistance Exercise Dietary Supplement: diet orange soda Dietary Supplement: essential amino acids

Genetics Home Reference related topics: adenosine monophosphate deaminase deficiency

MedlinePlus related topics: Dietary Supplements Exercise and Physical Fitness

Drug Information available for: Amino acids, branched-chain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment
Official Title:	Combined Effects of Nutritional and Exercise Countermeasures

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Fractional synthetic rate of muscle growth. [ Time Frame: two days. ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental 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.
1: Placebo Comparator Subjects receive inert substance versus protein supplement.	Dietary Supplement: diet orange soda Subjects drink diet orange soda 3x day for 2 days.
3: Experimental Resistance exercise.	Behavioral: Resistance Exercise Subjects will lift weights with their legs.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447044

Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator:

Arny Ferrando, PhD

University of Arkansas

More Information

Responsible Party:	UAMS ( Arny A. Ferrando, PhD )
Study ID Numbers:	72779
Study First Received:	March 12, 2007
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00447044
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Arkansas:

Muscle loss and Maintenance of Muscle function

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Asthenia

Neurologic Manifestations
Atrophy
Muscle Weakness
Muscular Atrophy

Additional relevant MeSH terms:

Neuromuscular Manifestations
Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009