Combined Effects of Nutritional and Exercise Countermeasures

Sponsor
University of Arkansas (Other)
Overall Status
Completed
CT.gov ID
NCT00447044
Collaborator
(none)
31
1
3
29
1.1

Study Details

Study Description

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 Phase
  • Behavioral: Resistance Exercise
  • Dietary Supplement: diet orange soda
  • Dietary Supplement: essential amino acids
N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2007
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Fractional synthetic rate of muscle growth. [two days.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00447044
Other Study ID Numbers:
  • 72779
First Posted:
Mar 13, 2007
Last Update Posted:
Jun 19, 2009
Last Verified:
Jun 1, 2009
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 19, 2009