Combined Effects of Nutritional and Exercise Countermeasures

June 17, 2009 updated by: University of Arkansas
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Subjects drink essential amino acid supplement 3x day for 2 days.
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.
Subjects drink diet orange soda 3x day for 2 days.
Experimental: 3
Resistance exercise.
Subjects will lift weights with their legs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fractional synthetic rate of muscle growth.
Time Frame: two days.
two days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arny Ferrando, PhD, University of Arkansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

March 12, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (Estimate)

March 13, 2007

Study Record Updates

Last Update Posted (Estimate)

June 19, 2009

Last Update Submitted That Met QC Criteria

June 17, 2009

Last Verified

June 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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