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

Completed · Not applicable · Has a placebo group

Conditions studied: Immunosenescence, Sarcopenia

In brief

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.

Key facts

Study ID

NCT01935271

Run by

Central Arkansas Veterans Healthcare System

People needed

12

Starts

2013-01-01

Expected to finish

2013-08-01

Last updated by the study team

2013-11-13

Who can join

Age: 60 and older, up to 80. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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