- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00447044
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 72779
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.
Clinical Trials on Muscle Weakness
-
St. Luke's-Roosevelt Hospital CenterCompletedFall Risk | Quadriceps Muscle Weakness | Adductor Muscle WeaknessUnited States
-
Association Pro-arteActive, not recruitingWeakness, Muscle | AmyotrophiaFrance
-
University of Central ArkansasCompletedPelvic Floor Muscle WeaknessUnited States
-
Ludwig Boltzmann Institute of Electrical Stimulation...Medical University of Vienna; European Union; Comenius University; Ministry of...CompletedMuscle Weakness Condition | Therapy EffectAustria, Slovakia
-
Rutgers, The State University of New JerseyRecruitingPhysical Disability | Muscle Atrophy or Weakness | Muscle Loss | Physical Inactivity | Delirium in Old Age | Hospital Acquired Condition | Weakness, MuscleUnited States
-
University of Central FloridaCompletedMuscle Weakness | Muscle Atrophy | Muscle Loss | Weakness, Muscle | Injury, KneeUnited States
-
University of MilanCompleted
-
University of Texas Southwestern Medical CenterTerminatedMuscle Cramp | Statin Adverse Reaction | Weakness, Muscle | AcheUnited States
-
Damanhour UniversityCompletedNeuromuscular Electrical Stimulation | ICU Acquired Muscle WeaknessEgypt
-
Messiah CollegeNot yet recruiting
Clinical Trials on essential amino acids
-
Texas A&M UniversityRecruiting
-
University of TorontoCompletedHealthy | Increased Metabolic Requirement
-
University of BirminghamUnknown
-
The Swedish School of Sport and Health SciencesRecruitingObesity | Sarcopenia | Aging | Sarcopenic ObesitySweden
-
Coordinación de Investigación en Salud, MexicoFresenius KabiCompleted
-
University of ArkansasWithdrawn
-
Arizona State UniversityMayo ClinicTerminatedHeart Failure, DiastolicUnited States
-
University of NottinghamAjinomoto Co., Inc.Unknown
-
University of TorontoAjinomoto Co., Inc.CompletedHealthy | Increased Metabolic Requirement
-
Dr. Chris McGlory, PhDRecruitingMuscular Atrophy | Anterior Cruciate Ligament ReconstructionCanada