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OpenTrials
Completed

NCT Number: NCT00447044

Combined Effects of Nutritional and Exercise Countermeasures

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance exercise

Behavioral

Subjects will lift weights with their legs.

diet orange soda

Dietary Supplement

Subjects drink diet orange soda 3x day for 2 days.

Essential Amino Acids

Dietary Supplement

Subjects drink 15 grams of EAA mixed into diet orange soda 3x day for 2 days.

Primary outcomes

  1. Fractional synthetic rate of muscle growth.

    Time frame: two days.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 13, 2007
Registry last updated
Jun 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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