Nutritional Supplementation and Muscle Health: A Pilot Study on Immune Function

This study has been completed.
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01935271
First received: February 20, 2013
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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 Intervention
Immunosenescence
Sarcopenia
Dietary Supplement: Muscle Armor Supplement
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nutritional Supplementation and Muscle Health: A Pilot Study on Immune Function

Resource links provided by NLM:


Further study details as provided by Central Arkansas Veterans Healthcare System:

Primary Outcome Measures:
  • Change in antibody titer to tetanus, diptheria, pertussis antigen post-vaccination. [ Time Frame: Baseline, 1 and 2 weeks post-vaccination ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in gene expression and protein levels in muscle and/or blood. [ Time Frame: Baseline and after 2-weeks of supplementation ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: January 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Veteran
  • Age 60-80 years
  • Body Mass Index of 18.5 - 29.9 kg/m2

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01935271

Locations
United States, Arkansas
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
Central Arkansas Veterans Healthcare System
University of Arkansas
Investigators
Principal Investigator: Richard Dennis, PhD Central Arkansas Veterans Healthcare System
  More Information

Publications:
Responsible Party: Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT01935271     History of Changes
Other Study ID Numbers: 391351
Study First Received: February 20, 2013
Last Updated: November 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Central Arkansas Veterans Healthcare System:
immunosenescence
sarcopenia

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014