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Effect of Age and Fitness on Vascular Function and Oxidative Stress During Acute Inflammation

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University of Illinois

Status and phase

Terminated
Phase 4

Conditions

Aging
Inflammation

Treatments

Dietary Supplement: Ascorbic Acid
Biological: Typhoid Vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT03889158
2018-1550

Details and patient eligibility

About

This study focuses on whether high cardiorespiratory fitness in older adults has a protective effect on the vascular response to acute inflammation in comparison to low-fit older and young adults.

Full description

Acute and chronic inflammation both increase cardiovascular disease risk, especially with aging, which may be due to vascular dysfunction. Aging and inflammation also lead to increased oxidative stress, which impairs vascular function. During acute inflammation, endothelial function is altered differently in younger and older adults with decreases in endothelial function in younger, but not older adults. However, cardiorespiratory fitness is cardio-protective, impacting inflammation, vascular function, and oxidative stress. During acute inflammation, moderately fit older adults exhibit similar responses to younger adults, suggesting preserved endothelial reactivity. However, whether the protective mechanism is oxidative stress has not been confirmed. Furthermore, it is undetermined whether the vascular dysfunction is further propagated down the arterial tree during acute inflammation to the microvasculature.

The aims of this research study are to determine if age and fitness moderate the vascular response to acute inflammation and to determine if antioxidant administration eliminates vascular dysfunction during acute inflammation. The results from this study will help to elucidate if fitness is a protective and preventive measure to ameliorate the detrimental cardiovascular response to acute inflammation. Thus, this study may provide health professionals with a behavioral intervention to reduce cardiovascular disease burden in the rapidly growing aging population.

Enrollment

35 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Males and females willing to provide informed consent
  • 18-35 or 55-75 years of age
  • Non-smoker
  • No use of anti-inflammatory medication within last 2 weeks
  • Aerobically trained (defined as performing aerobic exercise on ≥4 days/week, for ≥30 minutes, for at least the past 3 months AND a VO2max ≥75th age- and sex-specific percentile according to ACSM)
  • /// OR /// Sedentary (defined as being involved in less than 30 minutes of moderately-intense physical activity per day, < 3 days/week AND a VO2max ≤ 50th age- and sex-specific percentile according to ACSM)

Exclusion criteria

  • Body mass index >35 kg/m2
  • Pregnancy, hormone replacement therapy, or peri-menopausal
  • Known cardiovascular (i.e. atherosclerosis, uncontrolled hypertension, stroke, myocardial infarction, etc.), inflammatory (i.e. Crohn's disease, arthritis, etc.), or metabolic (i.e. Diabetes mellitus) disease
  • Medications known to influence cardiovascular outcomes (i.e. heart rate, blood pressure, endothelial function, etc)
  • Regular use of medications to reduce inflammation (NSAIDS, aspirin, steroids, etc)
  • Bleeding disorders
  • Illness, other vaccination, or antioxidant use within 2 weeks prior to screening
  • Typhoid vaccination within previous 2 years or prior adverse reaction
  • VO2max in 51st - 74th age- and sex-specific percentile according to ACSM (measured during first testing visit)
  • Non-English speaking participants

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 2 patient groups

Acute Inflammation
Experimental group
Description:
All participants will receive the typhoid vaccination (intramuscular injection, 0.5 mL, 1 time).
Treatment:
Biological: Typhoid Vaccine
Ascorbic Acid
Experimental group
Description:
All participants will receive ascorbic acid (Vit C) on two occasions \[oral pill, 2g, 2x (baseline, during acute inflammation)\].
Treatment:
Dietary Supplement: Ascorbic Acid

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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