Restoring Glycocalyx Thickness in Older Adults to Improve Vascular Function

Last updated: February 26, 2024
Sponsor: University of Iowa
Overall Status: Completed

Phase

N/A

Condition

Aging

Atherosclerosis

Treatment

Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572)

Clinical Study ID

NCT06071728
202204445
  • Ages 60-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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 glycocalyx protects endothelial cells from oxidative stress and inflammation and enables blood vessel dilation, which is largely dependent on the bioavailability of the vasodilatory molecule nitric oxide. Importantly, glycocalyx thickness decreases with age and is predictive of major adverse cardiovascular events in older adults free of cardiovascular disease. Therefore, interventions aimed at restoring glycocalyx thickness in older adults are desperately needed. Endocalyx Pro is a commercially available glycocalyx precursor supplement, manufactured by Microvascular Health Solutions, designed to

  1. repair a damaged glycocalyx, 2) protect against damage to the glycocalyx, and 3) synthesize new glycocalyx components, and has been used to increase glycocalyx thickness in humans. However, no study has tested if glycocalyx thickness restores glycocalyx thickness in older adults and improves blood vessel function. Thus, the purpose of this investigation is to determine if 12-weeks of Endocalyx Pro supplementation alters glycocalyx thickness and blood vessel function in older adults. The investigators will use a camera placed under the tongue to determine glycocalyx thickness. The investigators will measure blood vessel function by measuring brachial artery dilation with ultrasound and arterial stiffness using pressure probes placed on the carotid and femoral artery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 60-85 years
  • Able to undergo cardiovascular testing procedures including fasting overnight andholding 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

Exclusion Criteria:

  • Current or history of CVD disease (heart attack, stroke, heart failure, cardiomyopathyor peripheral artery disease, heart angioplasty/stent or bypass surgery, valvereplacement, carotid endarterectomy, heart transplant.
  • Medical history of stroke or other neurological disorder or systemic illness thatcould potentially affect cognition or brain function (outside of a diagnosis of MCI,Alzheimer's Disease) or could affect their safety or comfort while undergoing theimaging or cardiovascular studies.
  • Subjects with evidence of cardiovascular disease at baseline or during the exercisetest (evidence of myocardial infarction, abnormal cardiac arrhythmia, myocardialischemia, conduction delays, >1mm ST segment depression or elevation; >3 beatventricular 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 psychiatricdisease (other than dementia).
  • Unable to provide informed consent due to cognitive impairment
  • Current clinically abnormal thyroid function not adequately regulated by thyroidhormone 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 whosmokes/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 requiringchemotherapy 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 toenrollment and maintain throughout the duration of the study.
  • Inability to comply with experimental instructions.
  • Uncontrolled intercurrent illness that would limit compliance with study requirementsper 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 orintervention.
  • Initiation of a new prescription medication or change in dose/frequency in the pastthree months. Individuals will be become eligible after the medication/dose/frequencyhas been stable for 3 months.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572)
Phase:
Study Start date:
October 10, 2022
Estimated Completion Date:
January 31, 2024

Connect with a study center

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

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