N/A
N=40
Muscle Mass During Space Exploration
Muscle Loss
Bottom Line
View on ClinicalTrials.gov: NCT00968344 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Lean Leg Mass — -1.2; -0.9 g
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Leucine (Dietary_supplement); Alanine (Dietary_supplement)
- Age
- Adult · 45+ yrs
- Sex
- All
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lean Leg Mass |
-1.2; -0.9 | — |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00968344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.