Combined Effects of Nutritional and Exercise Countermeasures | NCT00447044

Studies
Combined Effects of Nutritional and Exercise Countermeasures

NCT00447044

Sponsor

University of Arkansas

Status

Completed

Last Update Posted

Jun 19, 2009Estimated

Enrollment

31Actual

Phase

Not Applicable

Conditions

Muscular Atrophy
Muscle Weakness

Interventions

Resistance Exercise
diet orange soda
essential amino acids

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Mar 12, 2007

First Submission Date that Met QC Criteria

Mar 12, 2007

First Posted Date

Mar 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2009

Last Update Posted Date

Jun 19, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Experimental	Subjects drink essential amino acid supplement 3x day for 2 days.	Dietary Supplement: essential amino acids
1	Placebo Comparator	Subjects receive inert substance versus protein supplement.	Dietary Supplement: diet orange soda
3	Experimental	Resistance exercise.	Behavioral: Resistance Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resistance Exercise	Behavioral	Subjects will lift weights with their legs.	3

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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D001284	Atrophy

ID	Term
D055070	Resistance Training
D000601	Amino Acids, Essential

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

ID	Term
D009133	Muscular Atrophy
D018908	Muscle Weakness