Status:

COMPLETED

Restoring Glycocalyx Thickness in Older Adults to Improve Vascular Function

Lead Sponsor:

University of Iowa

Conditions:

Aging

Vascular Stiffness

Eligibility:

All Genders

60-85 years

Phase:

NA

Brief Summary

The glycocalyx serves as the interface between flowing blood and endothelial cells, the single cell layer that lines blood vessels, and is crucial for normal blood vessel function. Specifically, the g...

Eligibility Criteria

Inclusion

  • Age 60-85 years
  • Able to undergo cardiovascular testing procedures including fasting overnight and holding selected morning medication doses.
  • Ability to understand and willingness to sign a written informed consent document.
  • Ability to lie comfortably for up to 90 minutes
  • Women only: Post-menopausal

Exclusion

  • Current or history of CVD disease (heart attack, stroke, heart failure, cardiomyopathy or peripheral artery disease, heart angioplasty/stent or bypass surgery, valve replacement, carotid endarterectomy, heart transplant.
  • Medical history of stroke or other neurological disorder or systemic illness that could potentially affect cognition or brain function (outside of a diagnosis of MCI, Alzheimer's Disease) or could affect their safety or comfort while undergoing the imaging or cardiovascular studies.
  • Subjects with evidence of cardiovascular disease at baseline or during the exercise test (evidence of myocardial infarction, abnormal cardiac arrhythmia, myocardial ischemia, conduction delays, \>1mm ST segment depression or elevation; \>3 beat ventricular tachycardia; atrial fibrillation) will be excluded from the study.
  • Wilson's disease, hemochromatosis
  • Individuals taking clonidine or other short-acting beta blocker
  • Resting blood pressure \> 149 mmHg systolic and/or 99mmHg diastolic
  • BMI \> 40 kg/m2
  • Medical history of chronic major psychiatric or current diagnosis of major psychiatric disease (other than dementia).
  • Unable to provide informed consent due to cognitive impairment
  • Current clinically abnormal thyroid function not adequately regulated by thyroid hormone supplementation or medication.
  • Allergic to olives, artichokes, grapes or melons
  • Current tobacco user or history of tobacco use within the past 3 months (cigarettes, cigars, chewing tobacco, hookah, electronic cigarettes) or living with someone who smokes/has smoked in the past 3 months.
  • Current diagnosis of diabetes (Type I or insulin dependent Type II)
  • Current diagnosis of COPD, cystic fibrosis, emphysema, chronic bronchitis
  • History of renal failure, dialysis or kidney transplant
  • Current diagnosis or history of liver disease or HIV/AIDS, or cancer requiring chemotherapy or radiation.
  • Current diagnosis or history of rheumatoid arthritis, systemic lupus erythematosus, Wegener's granuomatosis
  • Vulnerable populations (prisoners, etc) will not be eligible.
  • Unwillingness to wash out from a vitamin or dietary supplement regime prior to enrollment and maintain throughout the duration of the study.
  • Inability to comply with experimental instructions.
  • Uncontrolled intercurrent illness that would limit compliance with study requirements per investigator.
  • Inability to fast or hold morning medications doses until after testing is complete.
  • Hormone replacement use within the past 6 months
  • Currently enrolled in another study using an study medication, supplement, device or intervention.
  • Initiation of a new prescription medication or change in dose/frequency in the past three months. Individuals will be become eligible after the medication/dose/frequency has been stable for 3 months.

Key Trial Info

Start Date :

October 10 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 31 2024

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT06071728

Start Date

October 10 2022

End Date

January 31 2024

Last Update

February 28 2024

Active Locations (1)

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University of Iowa

Iowa City, Iowa, United States, 52242