MedDataX Logo

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

NCT ID: NCT03889158

Last Updated: 2021-11-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-25

Study Completion Date

2020-03-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aging Inflammation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cardiorespiratory Fitness Endothelial Function Oxidative Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acute Inflammation

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

Group Type EXPERIMENTAL

Typhoid Vaccine

Intervention Type BIOLOGICAL

All participants will receive the typhoid vaccine.

Ascorbic Acid

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

Group Type EXPERIMENTAL

Ascorbic Acid

Intervention Type DIETARY_SUPPLEMENT

All participants will receive ascorbic acid.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Typhoid Vaccine

All participants will receive the typhoid vaccine.

Intervention Type BIOLOGICAL

Ascorbic Acid

All participants will receive ascorbic acid.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Typhim Vi Typhoid Vi Polysaccharide Vaccine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Elizabeth Schroeder

PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elizabeth Schroeder, MS

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Integrative Physiology Laboratory, Suite 158

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-1550

Identifier Type: -

Identifier Source: org_study_id