Restoring Glycocalyx Thickness in Older Adults to Improve Vascular Function

NCT06071728 | Completed

• 1 other identifier: 202204445
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Aging; Vascular Stiffness; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (2)

• Brachial artery flow-mediated dilation (FMD)

  Conduit artery vascular endothelial function

  Baseline and 12 weeks

• Perfused boundary region (PBR)

  Microvascular endothelial glycocalyx thickness

  Baseline and 12 weeks

Study Arms (2)

Endocalyx Pro

ACTIVE COMPARATOR

Subjects will receive 6 capsules per day (3,712mg) of Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572), a commercially available supplement that includes a proprietary blend of glycocalyx precursors and antioxidants

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

Placebo

PLACEBO COMPARATOR

Subjects will ingest placebo pills

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

Interventions

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

Subjects will receive Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572) (3,712mg) or placebo for 12 weeks.

Endocalyx Pro; Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Study Officials

• Gary Pierce, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 6, 2023
• Study Start: October 10, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)