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

NCT03889158 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2018-1550
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Inflammation

Keywords

Cardiorespiratory Fitness; Endothelial Function; Oxidative Stress

Outcome Measures

Primary Outcomes (2)

• 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).

  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]

• 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.

  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 (1)

• Change in Arterial Stiffness

  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]

Study Arms (2)

Acute Inflammation

EXPERIMENTAL

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

Biological: Typhoid Vaccine

Ascorbic Acid

EXPERIMENTAL

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

Dietary Supplement: Ascorbic Acid

Interventions

Typhoid Vaccine BIOLOGICAL

All participants will receive the typhoid vaccine.

Also known as: Typhim Vi, Typhoid Vi Polysaccharide Vaccine

Acute Inflammation

Ascorbic Acid DIETARY_SUPPLEMENT

All participants will receive ascorbic acid.

Ascorbic Acid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females willing to provide informed consent
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

Integrative Physiology Laboratory, Suite 158

Chicago, Illinois, 60608, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Typhoid-Paratyphoid Vaccines; Vi polysaccharide vaccine, typhoid; Ascorbic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salmonella Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Dr. Elizabeth Lefferts
• Organization: University of Illinois at Chicago

eschro7@uic.edu

312-996-9607

Study Officials

• Elizabeth Schroeder, MS

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 26, 2019
• Study Start: March 25, 2019
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: November 12, 2021
• Results First Posted: November 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)