Multiple clinical studies on the effectiveness of Endocalyx Pro™ and its ingredients have been either completed or are in progress.

Plus, there are many double-blind studies planned by researchers that will launch in the future. It takes years to complete these studies, and even after they are completed it can take months before the peer-reviewed research study is released to the public.

Glycocalyx Damage by Kidney Patients’ Plasma Restored with Endocalyx Pro

A peer-reviewed study published in the International Journal of Molecular Sciences on the use of Endocalyx Pro™ to protect the glycocalyx on endothelial cells exposed to kidney patients’ plasma.

This study, focused on kidney patients, reveals that the patented formulation of Endocalyx Pro restores the endothelial glycocalyx when exposed to toxic hemodialysis plasma. A healthy endothelial glycocalyx facilitates the exchange of nutrients, hormones, and oxygen, along with removal of waste and carbon dioxide, from all vital organs.

The study is titled “A Dietary Supplement Containing Fucoidan Preserves Endothelial Glycocalyx through ERK/MAPK Signaling and Protects against Damage Induced by CKD Serum,” The authors of the study included researchers from University Hospital Münster, Maastricht University.

Patients with Chronic Kidney Disease (CKD) have a very high risk of cardiovascular disease and premature death when they need to be treated with hemodialysis to detoxify their blood when their kidneys are failing. The toxins in the blood of hemodialysis CKD patients damage their blood vessels, and many recent studies have demonstrated that the increased cardiovascular risk is associated with damage of the endothelial glycocalyx, a protective gel-like polysaccharide matrix on the luminal surface of the vascular endothelium.

Although many studies confirm that a damaged glycocalyx is related to cardiovascular complications and is associated with poor outcomes for critically ill patients in the ICU, therapeutic options that target to protect, repair, or restore the endothelial glycocalyx are still lacking. It is therefore very exciting that the published study by Manuel Regier and Carolin Drost investigated the potential of the dietary supplement Endocalyx Pro to protect and restore the endothelial glycocalyx in the presence of toxic hemodialysis plasma.

Not only was Endocalyx Pro able to restore the dimension of the endothelial glycocalyx after damage by the hemodialysis plasma samples, but the study also demonstrated that Endocalyx Pro could prevent endothelial glycocalyx damage in the presence of the glycocalyx degrading enzyme heparinase, levels of which are high in the blood of hemodialysis patients.

In addition to these exciting, protective, and restorative properties of Endocalyx Pro in an acute model of endothelial glycocalyx damage by exposure to toxic hemodialysis plasma, the authors also demonstrated that adding Endocalyx Pro to the food of mice for only two weeks, resulted in significant uptake of Endocalyx Pro in the blood of these mice, which resulted in a thicker glycocalyx in mice eating the supplement as measured using the GlycoCheck patented software.

Finally, the study demonstrated that several specific cellular pathways, as well as inhibition of the enzyme heparinase, are involved in the protective and restorative effect of Endocalyx in the context of enzymatic and chronic kidney disease-induced damage of the endothelial glycocalyx.

Additional Endocalyx Pro Studies

Endocalyx Pro has completed and has ongoing studies that been running since 2015. These studies are in cell cultures, animals, and in humans. The studies in humans include double-blind placebo designs. These studies are on the following health conditions and diseases:

Type keywords in the search function to narrow your search to specific conditions and diseases:

Additional studies are being written and in the approval process will be devoted to these conditions:
  • Scleroderma
  • Erectile Dysfunction
  • Emergency Room Admissions
  • Arterial Plaque Development
  • Hair Growth

Dietary Interventions on Glycocalyx Dimensions in South Asian Patients With Diabetic Nephropathy. (Glycotreat)

Sponsor:
Leiden University Medical Center

Collaborators:
Dutch Kidney Foundation
Health Holland
Radboud University

Subsidizing Party:
Health Holland (Dutch Top Sector Life Sciences & Health)
Laan van Nieuw Oost-Indië 334,
2593 CE Den Haag
The Netherlands

Dutch Kidney Foundation
Groot Hertoginnelaan 34
1405 EE, Bussum
The Netherlands

Laboratory Sites:
Leiden University Medical Center, The Netherlands
Radboud University Medical Center, The Netherlands

Objective:
To investigate whether intervention with the dietary supplement Endocalyx™ improves the
Microvascular Health Index between baseline and 3 months in type 2 diabetic South Asian patients with
microalbuminuria in comparison to the placebo group.

Read the full trial information here.


Dietary Glycocalyx Precursor Supplementation Ameliorates Age-Related Vascular Dysfunction

 

Daniel R Machin, Daniel Nguyen, R Colton Bramwell, Lisa A Lesniewski, and Anthony J Donator

Daniel Machin and Tony Donato published an abstract at the Experimental Biology 2019 meeting on the effect of Endocalyx on aging in mice:

Published in The FASEB Journal (volume 33, Issue 1_supplement, 01 April 2019):

Published Online: 1 Apr 2019 Abstract Number: 828.1

Abstract

Large elastic artery stiffening and endothelial dysfunction, and associated reductions in nitric oxide (NO) bioavailability, are central features of vascular aging. We have recently demonstrated that the glycocalyx, a gel-like structure that is bound to the luminal surface of the vascular endothelium, is dysfunctional in the aged vasculature. The glycocalyx has several functions that are critical for the maintenance of a healthy vasculature. We sought to determine if chronic dietary supplementation of glycocalyx precursors (glucosamine sulfate, fucoidan, superoxide dismutase, and high molecular weight hyaluronan) could restore glycocalyx function, while concomitantly ameliorating age-related vascular dysfunction. Young (Y: 7 mo) and old (O: 30 mo) male B6D2F1 mice consumed a control (C) or glycocalyx precursor (GP: 37 mg/kg encapsulated chow provided courtesy of MicroVascular Health Solutions, LLC [U.S. Patent Serial No. 9,943,572]) diet ad libitum for 10 weeks. Glycocalyx barrier function (perfused boundary region [PBR]) was evaluated in the mesenteric microcirculation using an intravital microscope equipped with an automated capture and analysis system. PBR was ~13% higher in OC compared to YC, suggestive of an age-related impairment in glycocalyx barrier function, and this was normalized in OGP mice (Both P<0.05; Figure 1). At baseline, aortic pulse wave velocity (PWV), a measure of large artery stiffness, was higher in OC and OGP compared with YC mice (Both P<0.05; Figure 2). However, after the dietary intervention, PWV decreased by ~13% in OGP (P<0.05), whereas, PWV was unchanged in OC and YC mice after the 10 week period (P>0.05). We assessed endothelial function by endothelium-dependent dilation (EDD, maximal response to acetylcholine [ACh]) in the carotid artery. Carotid artery EDD was higher in YC and OGP compared to OC mice (92.5±2.4 and 90.7±2.3 vs. 69.0±4.9%, respectively, P<0.05). EDD of OGP was similar to YC mice (P>0.05). After incubation with the nitric oxide (NO) synthase inhibitor, L-NAME, the dilatory response did not differ between groups (P>0.05). NO bioavailability (max ACh dilation - max ACh+L-NAME dilation) was ~10–14 fold higher in YC and OGP compared to OC mice (Both P<0.05; Figure 3). Endothelium-independent dilation (vasodilation to sodium nitroprusside) was not different between groups (P>0.05). In young mice, GP diet did not affect any of the aforementioned measurements (P>0.05). In conclusion, 10 weeks of dietary GP supplementation in old mice restores glycocalyx barrier function that is accompanied by reduced aortic stiffness and augmented EDD and NO bioavailability, suggesting that the glycocalyx may be an effective therapeutic target for vascular dysfunction in older adults.

Support or Funding Information

This study was funded in part by grants from the National Institute of Health (R01 AG040297, R01 AG048366, K02 AG045339, K99 AT010017) and US Department of Veterans Affairs (1I01BX002151).

Read the Abstract here.


Pilot Study in 13 Healthy Volunteers


Summary of Findings from Clinical Studies

6.3.2 Food supplement
A pilot study was conducted among 13 healthy volunteers receiving the Endocalyx food supplement. After 3 months, the Microvascular Health Index measured by SDF imaging improved by 31%. After 4 months, the Microvascular Health Index in the volunteers improved by 50%. This showed the beneficial effects of the food supplement on the microvasculature as it significantly increased capillary density and red blood cell filling percentage, and reduced the perfused boundary region (unpublished data, H. Vink).

Summary of Known and Potential Risks and Benefits

6.4.2 Food supplement
In the pilot study with Endocalyx, no serious adverse effects were reported. One side effect that was reported was dizziness, as the Endocalyx supplement lowered the systolic blood pressure. The supplement is already used in general practitioners’ offices in the United States and to date; no one reported any major side effects. Studies conducted with the individual ingredients also did not report any serious adverse effects. A possible side effect may be an unknown allergic reaction to one of the ingredients of the supplement. Benefits of the Endocalyx food supplement in diabetic patients remain to be established but are mainly improving the microvascular health by supporting endothelial glycocalyx function.

Read more about the Endocalyx Use Study Report here.

As stated above, it takes years to complete studies like these, and even after they are completed it can take months before the peer-reviewed research study is released to the public. As soon as results are available, we will share them publicly on this page.