AgingRESTORENCT06071728
Restoring Glycocalyx Thickness in Older Adults to Improve Vascular Function
A study testing Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572) in people with Aging and Vascular Stiffness, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Vascular Stiffness, Endothelial Dysfunction
- What is being tested?
- Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572) |
| Placebo | Placebo comparator | Subjects will ingest placebo pills Receives: Dietary Supplement: Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow-mediated dilation (FMD)
Conduit artery vascular endothelial function
Measured: Baseline and 12 weeks
Perfused boundary region (PBR)
Microvascular endothelial glycocalyx thickness
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start10 Oct 2022
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary L. Pierce, PhD, University of Iowa
- Investigators
- Gary Pierce, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071728
- Sponsor's protocol ID
- 202204445
- Acronym
- RESTORE
- Status last verified
- Feb 2024
- First submitted
- 1 Oct 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual deidentified data will be shared with other researchers upon reasonable request.
Publications
Gimblet CJ, Donato AJ, Jalal DI, Pierce GL. Sex differences in endothelial glycocalyx thickness and the response to glycocalyx-targeted therapy among older adults. Physiol Rep. 2025 Jun;13(12):e70428. doi: 10.14814/phy2.70428.
PubMed 40526020
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Glycocalyx Thickness in Older Adults to Improve Vascular Function
- ClinicalTrials.gov ID
- NCT06071728
- Acronym / sponsor ID
- RESTORE / 202204445
- Conditions
- Aging, Vascular Stiffness, Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endocalyx Pro | Active comparator | Dietary Supplement: Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572)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 |
| Placebo | Placebo comparator | Dietary Supplement: Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572)Subjects will ingest placebo pills |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572)Subjects will receive Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572) (3,712mg) or placebo for 12 weeks. | Dietary supplement | Endocalyx Pro, Placebo |
Primary outcome
Brachial artery flow-mediated dilation (FMD)
Time frame: Baseline and 12 weeks
Conduit artery vascular endothelial function
Perfused boundary region (PBR)
Time frame: Baseline and 12 weeks
Microvascular endothelial glycocalyx thickness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 40526020Gimblet CJ, Donato AJ, Jalal DI, Pierce GL. Sex differences in endothelial glycocalyx thickness and the response to glycocalyx-targeted therapy among older adults. Physiol Rep. 2025 Jun;13(12):e70428. doi: 10.14814/phy2.70428.
- Individual participant dataSharing planned: No. Individual deidentified data will be shared with other researchers upon reasonable request.
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Pierce, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocalyx Pro (Microvascular Health Solutions, US Patent Number: 9943572) in people with Aging and Vascular Stiffness, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial artery flow-mediated dilation (FMD) (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06071728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.