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Combined Effects of Nutritional and Exercise Countermeasures

Primary Purpose

Muscular Atrophy, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Exercise
diet orange soda
essential amino acids
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Muscular Atrophy focused on measuring Muscle loss and Maintenance of Muscle function

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

2

1

3

Arm Description

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

Subjects receive inert substance versus protein supplement.

Resistance exercise.

Outcomes

Primary Outcome Measures

Fractional synthetic rate of muscle growth.

Secondary Outcome Measures

Full Information

First Posted
March 12, 2007
Last Updated
June 17, 2009
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT00447044
Brief Title
Combined Effects of Nutritional and Exercise Countermeasures
Official Title
Combined Effects of Nutritional and Exercise Countermeasures
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Arkansas

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Atrophy, Muscle Weakness
Keywords
Muscle loss and Maintenance of Muscle function

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
Subjects drink essential amino acid supplement 3x day for 2 days.
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Subjects receive inert substance versus protein supplement.
Arm Title
3
Arm Type
Experimental
Arm Description
Resistance exercise.
Intervention Type
Behavioral
Intervention Name(s)
Resistance Exercise
Intervention Description
Subjects will lift weights with their legs.
Intervention Type
Dietary Supplement
Intervention Name(s)
diet orange soda
Intervention Description
Subjects drink diet orange soda 3x day for 2 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
essential amino acids
Intervention Description
Subjects drink 15 grams of EAA mixed into diet orange soda 3x day for 2 days.
Primary Outcome Measure Information:
Title
Fractional synthetic rate of muscle growth.
Time Frame
two days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arny Ferrando, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

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Combined Effects of Nutritional and Exercise Countermeasures

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