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

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ClinicalTrials.gov Identifier: NCT03889158
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Elizabeth Schroeder, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Aging Inflammation Biological: Typhoid Vaccine/Ascorbic Acid Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Age and Fitness on Vascular Function and Oxidative Stress During Acute Inflammation
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
Experimental: Acute Inflammation/Antioxidant

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)].

Biological: Typhoid Vaccine/Ascorbic Acid
All participants will receive the typhoid vaccine and Vit C.
Other Names:
  • Typhim Vi
  • Typhoid Vi Polysaccharide Vaccine
  • Vitamin C




Primary Outcome Measures :
  1. Change in Endothelial function [ Time Frame: Visit 1: At baseline and 2 hours following Vitamin C consumption; Visit 2 (>72 hours after Visit 1): At baseline; Visit 3 (24 hours after Visit 2): At baseline and 2 hours following Vitamin C consumption ]

    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).

    We are interested in:

    1. How does endothelial function change before and during acute inflammation (Visit 2 baseline versus Visit 3 baseline) with varying fitness levels?
    2. Is the change in endothelial function during acute inflammation due to oxidative stress and does this vary by fitness level? We will compare the change in endothelial function at baseline from Visit 1 before and after the Vitamin C to the change during acute inflammation in Visit 3 before and after Vitamin C.

  2. Change in Oxidative Stress [ Time Frame: Visit 1: At baseline and 2 hours following Vitamin C consumption; Visit 2 (>72 hours after Visit 1): At baseline; Visit 3 (24 hours after Visit 2): At baseline and 2 hours following Vitamin C consumption ]

    Oxidized low-density lipoprotein, vitamin C and total antioxidant capacity will be assessed using standard ELISAs from a venous blood draw.

    We are interested in:

    1. How does oxidative stress change before and during acute inflammation (Visit 2 baseline versus Visit 3 baseline) with varying fitness levels?
    2. Is the change in endothelial function during acute inflammation due to oxidative stress and does this vary by fitness level? We will compare the change in oxidative stress at baseline from Visit 1 before and after the Vitamin C to the change during acute inflammation in Visit 3 before and after Vitamin C.


Secondary Outcome Measures :
  1. Change in Arterial stiffness [ Time Frame: Visit 1: At baseline and 2 hours following Vitamin C consumption; Visit 2 (>72 hours after Visit 1): At baseline; Visit 3 (24 hours after Visit 2): At baseline and 2 hours following Vitamin C consumption ]

    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.

    We are interested in:

    1. How does arterial stiffness change before and during acute inflammation (Visit 2 baseline versus Visit 3 baseline) with varying fitness levels?
    2. Is the change in arterial stiffness during acute inflammation due to oxidative stress and does this vary by fitness level? We will compare the change in arterial stiffness at baseline from Visit 1 before and after the Vitamin C to the change during acute inflammation in Visit 3 before and after Vitamin C.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889158


Contacts
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Contact: Elizabeth Schroeder, MS 312-996-9607 eschro7@uic.edu

Locations
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United States, Illinois
Integrative Physiology Laboratory, Suite 158 Recruiting
Chicago, Illinois, United States, 60608
Contact: Elizabeth Schroeder         
Sponsors and Collaborators
University of Illinois at Chicago

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Responsible Party: Elizabeth Schroeder, PhD Candidate, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03889158     History of Changes
Other Study ID Numbers: 2018-1550
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Elizabeth Schroeder, University of Illinois at Chicago:
Cardiorespiratory Fitness
Endothelial Function
Oxidative Stress
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Ascorbic Acid
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Nutrients
Growth Substances