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

Primary Purpose

Aging, Inflammation

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Typhoid Vaccine
Ascorbic Acid
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging focused on measuring Cardiorespiratory Fitness, Endothelial Function, Oxidative Stress

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Integrative Physiology Laboratory, Suite 158

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acute Inflammation

Ascorbic Acid

Arm Description

All participants will receive the typhoid vaccination (intramuscular injection, 0.5 mL, 1 time).

All participants will receive ascorbic acid (Vit C) on two occasions [oral pill, 2g, 2x (baseline, during acute inflammation)].

Outcomes

Primary Outcome Measures

Change in Endothelial Function
Flow-mediated dilation - Brachial artery vasodilator function will be noninvasively measured through assessment of brachial artery dilation using ultrasonography. The brachial artery will be imaged proximal to placement of a blood pressure cuff just below the antecubital fossa. Endothelium-dependent dilation of the brachial artery will be measured at baseline and again for 5 minutes following ischemic stimulus (inflation of a blood pressure cuff around the forearm to 250 mmHg for 5 minutes).
Change in Oxidative Stress
Oxidized low-density lipoprotein, vitamin C and total antioxidant capacity will be assessed using standard ELISAs from a venous blood draw. The analyses of the oxidized LDL and total antioxidant capacity failed. Only data on Vitamin C are presented.

Secondary Outcome Measures

Change in Arterial Stiffness
Central pulse wave velocity - Approximately 20-sec of pressure waveforms will be collected at the brachial, common carotid, and femoral arteries using a high-fidelity strain-gauge transducer. Pulse wave velocity will be calculated from the distances between measurement points and the measured time delay between proximal (carotid) and distal (femoral) waveforms.

Full Information

First Posted
March 20, 2019
Last Updated
October 15, 2021
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT03889158
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Inflammation
Keywords
Cardiorespiratory Fitness, Endothelial Function, Oxidative Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute Inflammation
Arm Type
Experimental
Arm Description
All participants will receive the typhoid vaccination (intramuscular injection, 0.5 mL, 1 time).
Arm Title
Ascorbic Acid
Arm Type
Experimental
Arm Description
All participants will receive ascorbic acid (Vit C) on two occasions [oral pill, 2g, 2x (baseline, during acute inflammation)].
Intervention Type
Biological
Intervention Name(s)
Typhoid Vaccine
Other Intervention Name(s)
Typhim Vi, Typhoid Vi Polysaccharide Vaccine
Intervention Description
All participants will receive the typhoid vaccine.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ascorbic Acid
Intervention Description
All participants will receive ascorbic acid.
Primary Outcome Measure Information:
Title
Change in Endothelial Function
Description
Flow-mediated dilation - Brachial artery vasodilator function will be noninvasively measured through assessment of brachial artery dilation using ultrasonography. The brachial artery will be imaged proximal to placement of a blood pressure cuff just below the antecubital fossa. Endothelium-dependent dilation of the brachial artery will be measured at baseline and again for 5 minutes following ischemic stimulus (inflation of a blood pressure cuff around the forearm to 250 mmHg for 5 minutes).
Time Frame
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]
Title
Change in Oxidative Stress
Description
Oxidized low-density lipoprotein, vitamin C and total antioxidant capacity will be assessed using standard ELISAs from a venous blood draw. The analyses of the oxidized LDL and total antioxidant capacity failed. Only data on Vitamin C are presented.
Time Frame
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 Outcome Measure Information:
Title
Change in Arterial Stiffness
Description
Central pulse wave velocity - Approximately 20-sec of pressure waveforms will be collected at the brachial, common carotid, and femoral arteries using a high-fidelity strain-gauge transducer. Pulse wave velocity will be calculated from the distances between measurement points and the measured time delay between proximal (carotid) and distal (femoral) waveforms.
Time Frame
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]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Schroeder, MS
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrative Physiology Laboratory, Suite 158
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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