Clinical trial NCT03889158: Effect of Age and Fitness on Vascular Function and Oxidative Stress During Acute Inflammation
Official title: Effect of Age and Fitness on Vascular Function and Oxidative Stress During Acute Inflammation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Aging
Inflammation
Keywords: Cardiorespiratory Fitness
Endothelial Function
Oxidative Stress
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The vascular response to acute inflammation and oxidative stress is non-invasively assessed in individuals who are young with low fitness, older with low fitness, or older with high fitness.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Endothelial Function
timeFrame: Visit 1: At [BASELINE] and 2 hours following Vit C [BASELINE+VIT C]; Visit 2 (>72 hours after Visit 1): At baseline [PRE-INFLAMMATION BASELINE]; Visit 3 (24 hours after Visit 2): At baseline [INFLAMMATION] and 2 hours following Vit C [INFLAMMATION+VIT C]
measure: Change in Oxidative Stress
timeFrame: Visit 1: At [BASELINE] and 2 hours following Vit C [BASELINE+VIT C]; Visit 2 (>72 hours after Visit 1): At baseline [PRE-INFLAMMATION BASELINE]; Visit 3 (24 hours after Visit 2): At baseline [INFLAMMATION] and 2 hours following Vit C [INFLAMMATION+VIT C]
Secondary outcomes:
measure: Change in Arterial Stiffness
timeFrame: Visit 1: At [BASELINE] and 2 hours following Vit C [BASELINE+VIT C]; Visit 2 (>72 hours after Visit 1): At baseline [PRE-INFLAMMATION BASELINE]; Visit 3 (24 hours after Visit 2): At baseline [INFLAMMATION] and 2 hours following Vit C [INFLAMMATION+VIT C]
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Integrative Physiology Laboratory, Suite 158
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Elizabeth Schroeder, MS
role: PRINCIPAL_INVESTIGATOR
References: