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

Primary Purpose

Immunosenescence, Sarcopenia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Muscle Armor Supplement

Placebo

About this trial

This is an interventional treatment trial for Immunosenescence focused on measuring immunosenescence, sarcopenia

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Central Arkansas Veterans Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Muscle Armor Supplement

Placebo

Arm Description

Treatment with a commercially available over the counter nutritional supplement

Sugar-based placebo drink mix

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01935271

First Posted

February 20, 2013

Last Updated

November 8, 2013

Sponsor

Central Arkansas Veterans Healthcare System

Collaborators

University of Arkansas

1. Study Identification

Unique Protocol Identification Number

NCT01935271

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Arkansas Veterans Healthcare System

Collaborators

University of Arkansas

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immunosenescence, Sarcopenia

Keywords

immunosenescence, sarcopenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Muscle Armor Supplement

Arm Type

Experimental

Arm Description

Treatment with a commercially available over the counter nutritional supplement

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Sugar-based placebo drink mix

Intervention Type

Dietary Supplement

Intervention Name(s)

Muscle Armor Supplement

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change in antibody titer to tetanus, diptheria, pertussis antigen post-vaccination.

Description

Time Frame

Baseline, 1 and 2 weeks post-vaccination

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline and after 2-weeks of supplementation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Dennis, PhD

Organizational Affiliation

Central Arkansas Veterans Healthcare System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Central Arkansas Veterans Healthcare System

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19435833

Citation

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.

Results Reference

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

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