Nutritional Supplementation and Muscle Health: A Pilot Study on Immune Function
|ClinicalTrials.gov Identifier: NCT01935271|
Recruitment Status : Completed
First Posted : September 5, 2013
Last Update Posted : November 13, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Immunosenescence Sarcopenia||Dietary Supplement: Muscle Armor Supplement Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Nutritional Supplementation and Muscle Health: A Pilot Study on Immune Function|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Experimental: Muscle Armor Supplement
Treatment with a commercially available over the counter nutritional supplement
|Dietary Supplement: Muscle Armor Supplement|
Placebo Comparator: Placebo
Sugar-based placebo drink mix
|Dietary Supplement: Placebo|
- Change in antibody titer to tetanus, diptheria, pertussis antigen post-vaccination. [ Time Frame: Baseline, 1 and 2 weeks 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.
- Change in gene expression and protein levels in muscle and/or blood. [ Time Frame: Baseline and after 2-weeks of supplementation ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935271
|United States, Arkansas|
|Central Arkansas Veterans Healthcare System|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Richard Dennis, PhD||Central Arkansas Veterans Healthcare System|