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

NCT01935271 | Completed

• 1 other identifier: 391351
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

immunosenescence; sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in gene expression and protein levels in muscle and/or blood.

  Baseline and after 2-weeks of supplementation

Study Arms (2)

Muscle Armor Supplement

EXPERIMENTAL

Treatment with a commercially available over the counter nutritional supplement

Dietary Supplement: Muscle Armor Supplement

Placebo

PLACEBO COMPARATOR

Sugar-based placebo drink mix

Dietary Supplement: Placebo

Interventions

Muscle Armor Supplement DIETARY_SUPPLEMENT

Muscle Armor Supplement

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Arkansas Veterans Healthcare System: lead
• University of Arkansas: collaborator

Study Sites (1)

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• 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.

  PMID: 19435833 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Richard Dennis, PhD

  Central Arkansas Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: September 5, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

US (1)