ImmunosenescenceNCT01935271
Nutritional Supplementation and Muscle Health: A Pilot Study on Immune Function
A study testing Muscle Armor Supplement in people with Immunosenescence and Sarcopenia, run by Central Arkansas Veterans Healthcare System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunosenescence, Sarcopenia
- What is being tested?
- Muscle Armor Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veteran
- Age 60-80 years
- Body Mass Index of 18.5 - 29.9 kg/m2
Who cannot join
- Participating in any other research study involving an intervention
- 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
Show all 51Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
About this study
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.
- Conditions
- Immunosenescence, Sarcopenia
- Being tested
- Muscle Armor Supplement, Placebo
- Keywords
- immunosenescence, sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Armor SupplementDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Muscle Armor Supplement | Experimental | Treatment with a commercially available over the counter nutritional supplement Receives: Dietary Supplement: Muscle Armor Supplement |
| Placebo | Placebo comparator | Sugar-based placebo drink mix Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 and 2 weeks post-vaccination
Secondary outcomes (1)
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.
Measured: Baseline and after 2-weeks of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImmunosenescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Arkansas Veterans Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- University of Arkansas
- Responsible party
- Sponsor
- Investigators
- Richard Dennis, PhD, Principal investigator, Central Arkansas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935271
- Sponsor's protocol ID
- 391351
- Status last verified
- Nov 2013
- First submitted
- 20 Feb 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19435833
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Supplementation and Muscle Health: A Pilot Study on Immune Function
- ClinicalTrials.gov ID
- NCT01935271
- Acronym / sponsor ID
- 391351
- Conditions
- Immunosenescence, Sarcopenia
- Keywords
- immunosenescence, sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Central Arkansas Veterans Healthcare SystemUS federal agency
- Collaborators
- University of Arkansas
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle Armor Supplement | Experimental | Dietary Supplement: Muscle Armor SupplementTreatment with a commercially available over the counter nutritional supplement |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSugar-based placebo drink mix |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veteran
- Age 60-80 years
- Body Mass Index of 18.5 - 29.9 kg/m2
Key exclusion criteria (51 listed)
- Participating in any other research study involving an intervention
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle Armor Supplement | Dietary supplement | Muscle Armor Supplement |
| Placebo | Dietary supplement | Placebo |
Primary outcome
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.
1 secondary outcome
Change in gene expression and protein levels in muscle and/or blood.
Time frame: Baseline and after 2-weeks of supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Background: PubMed 19435833Dennis 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Dennis, PhD principal investigator
Central Arkansas Veterans Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Armor Supplement in people with Immunosenescence and Sarcopenia, run by Central Arkansas Veterans Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in antibody titer to tetanus, diptheria, pertussis antigen post-vaccination. (time frame: Baseline, 1 and 2 weeks post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01935271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.