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| Name | Class |
|---|---|
| University of Arkansas | OTHER |
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The ability of older adults to improve their muscle strength through exercise training appears related to how well their immune system functions. Thus, a nutritional supplement which improves immune function could theoretically boost strength gained for older adults from exercise. The purpose of this pilot study is to determine if a nutritional supplement has any effect on immune function.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Muscle Armor Supplement | Experimental | Treatment with a commercially available over the counter nutritional supplement |
|
| Placebo | Placebo Comparator | Sugar-based placebo drink mix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muscle Armor Supplement | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in antibody titer to tetanus, diptheria, pertussis antigen post-vaccination. | The study will randomize subjects to consume supplement or placebo for 4-weeks. After two weeks of consumption, subjects will be vaccinated against tetanus, pertussis, and diphtheria. Blood will be drawn before and at two time points after vaccination. Change in antibody titer against the vaccine antigens will be calculated. A comparison between groups will determine if supplementation improves the antibody response to vaccination. | Baseline, 1 and 2 weeks post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gene expression and protein levels in muscle and/or blood. | The study will determine whether markers of inflammation in serum (e.g. C-reactive protein and cytokines) or blood mononuclear cells are decreased by the nutritional supplement. Blood will be drawn before and after periods of supplementation. The groups will be compared for protein and gene expression levels. The study will also determine whether supplementation affects muscle expression of genes associated with inflammation or tissue growth and remodeling. Muscle biopsies will be collected before and after two weeks of supplementation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Dennis, PhD | Central Arkansas Veterans Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Veterans Healthcare System | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19435833 | Background | 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. |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Dietary Supplement |
|
| Baseline and after 2-weeks of supplementation |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |