Combined Effects of Nutritional and Exercise Countermeasures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Muscular Atrophy Muscle Weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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2

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

Group Type EXPERIMENTAL

essential amino acids

Intervention Type DIETARY_SUPPLEMENT

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

1

Subjects receive inert substance versus protein supplement.

Group Type PLACEBO_COMPARATOR

diet orange soda

Intervention Type DIETARY_SUPPLEMENT

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

3

Resistance exercise.

Group Type EXPERIMENTAL

Resistance Exercise

Intervention Type BEHAVIORAL

Subjects will lift weights with their legs.

Interventions

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Resistance Exercise

Subjects will lift weights with their legs.

Intervention Type BEHAVIORAL

diet orange soda

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

Intervention Type DIETARY_SUPPLEMENT

essential amino acids

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes