Combined Effects of Nutritional and Exercise Countermeasures

NCT00447044 | Completed

• 1 other identifier: 72779
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscular Atrophy; Muscle Weakness

Keywords

Muscle loss and Maintenance of Muscle function

Outcome Measures

Primary Outcomes (1)

• Fractional synthetic rate of muscle growth.

  two days.

Study Arms (3)

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

Resistance Exercise BEHAVIORAL

Subjects will lift weights with their legs.

3

diet orange soda DIETARY_SUPPLEMENT

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

1

essential amino acids DIETARY_SUPPLEMENT

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

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Availability of transport and ability to report to Research Center at appointed times

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Muscular Atrophy; Muscle Weakness

Interventions

Resistance Training; Amino Acids, Essential

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Arny Ferrando, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 13, 2007
• Study Start: January 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 19, 2009

Record last verified: 2009-06

Locations

US (1)