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OpenTrials
Completed

NCT Number: NCT00968344

Muscle Mass During Space Exploration

The investigators will test the following hypotheses:

1. Bedrest will blunt the anabolic response to a mixed nutrient meal, facilitating a loss of muscle mass and functional capacity that is only partially restored during rehabilitation. 2. Enriching daily meals with leucine will promote protein synthesis and maintain the anabolic response to mixed nutrient meal ingestion. This will preserve lean muscle mass and function during bedrest and facilitate the recovery of functional and metabolic capacity during rehabilitation.

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Key information

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

About this study

Our long-term goal is to identify, prevent and remedy defects in the metabolic pathway that contribute to the loss of muscle mass and function during exposure to microgravity. Demographic data indicate that the average age of shuttle crew members has increased from 40.7 yrs in 1995 to 46.7 yrs in 2007 with an increasing number of astronauts over 50 yrs of age. We contend that the loss of muscle mass and function during spaceflight is facilitated by an age-associated, progressive impairment in the ability to mount an anabolic response to standard mixed nutrient meals. We propose that enriching daily meals with a low-volume leucine supplement will reduce the deleterious effects of microgravity on skeletal muscle and facilitate recovery during rehabilitation.

We will employ our established 14 day bed rest protocol to model the skeletal muscle unloading that occurs during microgravity. We will also examine recovery of muscle mass and functional capacity during a 7 day rehabilitation period. We will study 2 groups: CON (Bedrest/Recovery + Placebo; n=15), LEU (Bedrest/Recovery + Leucine; n=15). We will assess a) markers of translation initiation, b) muscle protein synthesis, c) muscle mass and body composition and d) strength and aerobic capacity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 45-60
  • Ability to sign informed consent

Exclusion criteria

  • Subjects with cardiac abnormalities considered exclusionary by the study physicians
  • Subjects with uncontrolled metabolic disease
  • A GFR <65 mL/min/1.73m2 or evidence of kidney disease or failure
  • Subjects with vascular disease or risk factors of peripheral atherosclerosis
  • Any history of hypo- or hyper-coagulation disorders. (e.g., Coumadin use or history of DVT or PE)
  • Subjects with chronically elevated systolic pressure >150 or a diastolic blood pressure > 100
  • Subjects with implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
  • Subjects with recently (6 months) treated cancer other than basal cell carcinoma
  • Any subject currently on a weight-loss diet or a body mass index > 30 kg/m2
  • Inability to abstain from smoking for duration of study
  • A history of > 20 pack per year smoking
  • Any subject that is HIV-seropositive or has active hepatitis
  • Recent anabolic or corticosteroids use (within 3 months)
  • Subjects with hemoglobin or hematocrit lower than accepted lab values
  • Agitation/aggression disorder
  • History of stroke with motor disability
  • A recent history (<12 months) of GI bleed
  • Any other condition or event considered exclusionary by the PI and faculty physician

Treatment and study plan

Leucine

Dietary Supplement

3-4g Leucine added to daily meals

Alanine

Dietary Supplement

Powered amino acid

Primary outcomes

  1. Lean Leg Mass

    Time frame: At baseline prior to beginning bed rest and after 14 days of bed rest

    DEXA scan of both legs pre/post bed rest

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

  • National Space Biomedical Research Institute

Registry information

Official study title

An Integrated Low-Volume Nutritional Countermeasure to Maintain Muscle Mass and Function During Space Exploration

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Aug 31, 2009
Registry last updated
May 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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