Nutritional Supplementation and Muscle Health: A Pilot Study on Immune Function
NCT ID: NCT01935271
Last Updated: 2013-11-13
Study Results
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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COMPLETED
NA
12 participants
INTERVENTIONAL
2013-01-31
2013-08-31
Brief Summary
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Veterans (age 60-80 yrs, N=12) be randomized in a double-blind placebo-controlled fashion to consume supplement or placebo for four weeks. After two weeks of consumption, subjects will be treated with a vaccine for tetanus, diphtheria, and pertussis. Blood will be drawn from each subject before and after vaccination to determine the effects of the supplement on immune response to vaccination. Additionally, subjects will undergo blood draw and muscle biopsy before and after two weeks of supplementation to determine the effects of supplementation on other measures of immune function (e.g. cytokine and growth factor levels). This is an important issue due to the serious health consequences associated with muscle loss in older adults and the need for improved strategies for rehabilitation.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Muscle Armor Supplement
Treatment with a commercially available over the counter nutritional supplement
Muscle Armor Supplement
Placebo
Sugar-based placebo drink mix
Placebo
Interventions
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Muscle Armor Supplement
Placebo
Eligibility Criteria
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Inclusion Criteria
* Age 60-80 years
* Body Mass Index of 18.5 - 29.9 kg/m2
Exclusion Criteria
* Smokes tobacco products
* Pains, tightness or pressure in chest during physical activity
* Participated in a weight-lifting targeting the thighs in last 3 months
* Problems walking or exercising with both legs
* Taking heparin, plavix / clopidogrel, or coumadin / warfarin
* Allergic to lidocaine
* Significant problem with fainting
* Allergic to vaccination
* Tetanus/diptheria/pertussis vaccine in previous two years
* Seizure in past 3 months
* Guillain-Barre Syndrome in past 3 months
* Enrolled in another interventional study
* Metastatic cancer or undergoing chemotherapy
* Cerebral aneurysm or intracranial bleed in past year
* End-stage congestive heart failure
* Unstable abdominal or thoracic aortic aneurysm
* Renal disease requiring dialysis
* Acute retinal hemorrhage or ophthalmologic surgery in past 3 months
* Bone fractures in the pelvis, legs, or feet in the last 3 months
* Hernia that causes pain during physical activity
* Myocardial infarction or cardiac surgery in past 3 months
* Pulmonary embolism or deep venous thrombosis in past 3 months
* Proliferative diabetic retinopathy or severe nonproliferative retinopathy
* Active suicidality or suicidal ideation
* Systemic bacterial infection
* Taking aspirin (in any form) and unable/unwilling to discontinue
* Unwilling to halt concurrent use of amino acid or protein supplements
* Unwilling to halt new use of nutritional supplements
* Unwilling to maintain current normal diet
* Encephalopathy in past 7 days
* Active oral or genital herpes
* Current use of appetite stimulants
* Current treatment for mania or bipolar disorder or taking lithium
* Diagnosis of a significant cognitive deficit
* Untreated severe aortic stenosis
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension or hypotension (\>160/100, \<100 systolic)
* Uncontrolled malignant cardiac arrhythmia
* Unstable angina (at rest or increased pattern in past month)
* Allergic to latex or tape
* Bleeding or clotting disorders
* Taking any nonsteroidal anti-inflammatories and unable to discontinue use
* Taking certain supplements and unable or unwilling to discontinue use
* Significant problems with chronic pain
* Uncontrolled asthma or allergies
* Taking lactulose, nitrates plus hypertension medications, or Viagra
* Liver cirrhosis or other severe liver disease
* History of peripheral artery disease
* Steroid or androgen use in past 3 months
* Other physician judgment
60 Years
80 Years
ALL
Yes
Sponsors
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University of Arkansas
OTHER
Central Arkansas Veterans Healthcare System
FED
Responsible Party
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Principal Investigators
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Richard Dennis, PhD
Role: PRINCIPAL_INVESTIGATOR
Central Arkansas Veterans Healthcare System
Locations
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Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States
Countries
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References
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Dennis RA, Zhu H, Kortebein PM, Bush HM, Harvey JF, Sullivan DH, Peterson CA. Muscle expression of genes associated with inflammation, growth, and remodeling is strongly correlated in older adults with resistance training outcomes. Physiol Genomics. 2009 Jul 9;38(2):169-75. doi: 10.1152/physiolgenomics.00056.2009. Epub 2009 May 12.
Other Identifiers
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391351
Identifier Type: -
Identifier Source: org_study_id