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CompletedNCT00447044Updated Jun 19, 2009

Combined Effects of Nutritional and Exercise Countermeasures

An interventional study of Resistance Exercise and diet orange soda in Muscular Atrophy and Muscle Weakness, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-06-19.

Sponsored by University of Arkansas · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Muscular Atrophy
  • Muscle Weakness

Keywords

  • Muscle loss and Maintenance of Muscle function
03

In context

Muscle Weakness

601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.

This study's enrollment of 31 is below the median of 46 across 444 interventional studies indexed under Muscle Weakness.

Browse Muscle Weakness studies →

Lead sponsor

University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    2

    Subjects drink essential amino acid supplement 3x day for 2 days.

    Dietary Supplement: essential amino acids

  • Placebo comparator
    1

    Subjects receive inert substance versus protein supplement.

    Dietary Supplement: diet orange soda

  • Experimental
    3

    Resistance exercise.

    Behavioral: Resistance Exercise

Interventions

  • BehavioralResistance Exercise

    Subjects will lift weights with their legs.

  • Dietary supplementdiet orange soda

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

  • Dietary supplementessential amino acids

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

06

What researchers measure

Primary outcomes

  1. Fractional synthetic rate of muscle growth.

    Time frame: two days.

07

Study locations

1 site
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00447044
Lead sponsor
University of Arkansas
First posted
Mar 13, 2007
Start date
Jan 2007
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Jun 19, 2009

Study contacts

Arny Ferrando, PhD
principal investigator · University of Arkansas
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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