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NCT06071728: RESTORE
Restoring Glycocalyx Thickness in Older Adults to Improve Vascular Function
NA trial testing Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572) in Aging in 24 participants. Completed in 31 January 2024.
31 December 2023
Quick facts
| Lead sponsor | University of Iowa |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 10 October 2022 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 January 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572)
Conditions studied
- Aging — all drugs for Aging →
- Vascular Stiffness — all drugs for Vascular Stiffness →
- Endothelial Dysfunction — all drugs for Endothelial Dysfunction →
Sponsor
University of Iowa
Who can join
Adults 60 to 85, any sex, with Aging or Vascular Stiffness. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effect of glycocalyx-targeted therapy on vascular function in older adults: a randomized controlled trial.
Gimblet CJ, Ernst JW, Bell B, Bos KD, et al · · 2024 · cited 7× · PMID 38722754 · DOI 10.1152/japplphysiol.00150.2024 -
Sex differences in endothelial glycocalyx thickness and the response to glycocalyx-targeted therapy among older adults.
Gimblet CJ, Donato AJ, Jalal DI, Pierce GL. · · 2025 · cited 1× · PMID 40526020 · DOI 10.14814/phy2.70428
Verify or expand the search:
- PubMed search for NCT06071728
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06071728 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Iowa
- Last refreshed: 28 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06071728.
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