Microvascular DysfunctionPhase 2NCT06683534
Palmitic Acid and Human Microvascular Function
A Phase 2 study testing Quercetin (dietary supplement) in people with Microvascular Dysfunction and Microvasculature, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The goal of this study is to learn how a supplement Quercetin can affect microvascular function. Participants will: give two blood draws of 5 mL each have a camera placed under the tongue to take pictures of blood vessels have 2 laser Doppler microdialysis catheters placed on the forearm to monitor blood vessels… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Microvascular Dysfunction, Microvasculature, Cardiovascular Diseases
- What is being tested?
- Quercetin (dietary supplement)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Obesity (BMI>30)
- Aged 18-40 years
- English Speaking
Who cannot join
- BMI>60
- Resting SBP ≥180 mmHg or DBP ≥ 110mmHg
- Pregnancy or breastfeeding.
- Prior history of myocardial infarction
- Diagnosis of more than 1 risk factor for coronary artery disease (active smoker, diabetes mellitus- type 1 or 2, congestive heart failure, hyperlipidemia, hypertension)
- Active mouth sores that affect the buccal mucosa.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Froedtert Hospital
Wauwatosa, Wisconsin, 53226
Julia Vogt, 4149552348, jvogt@mcw.edu
Julie Freed, MD, PhD
About this study
Official title: Use of Quercetin to Increase Resiliency to Palmitic Acid in the Human Microvasculature
The goal of this study is to learn how a supplement Quercetin can affect microvascular function.
Participants will:
- give two blood draws of 5 mL each
- have a camera placed under the tongue to take pictures of blood vessels
- have 2 laser Doppler microdialysis catheters placed on the forearm to monitor blood vessels before and after local drug infusion
Researchers will compare blood vessel function of those who take estrogen supplements to those who do not.
- Conditions
- Microvascular Dysfunction, Microvasculature, Cardiovascular Diseases, Cardiovascular Diseases (CVD), Microvascular Health, Obesity and Overweight
- Being tested
- Quercetin (dietary supplement), Placebo
- Keywords
- Obesity, Supplement
- Medical subject headings
- Cardiovascular Diseases, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quercetin (dietary supplement)Dietary supplement
Quercetin will be provided to take one Quercetin per day for 30 days to look for differences in microvascular function.
PlaceboDrug
Subjects randomized to receive placebo will be administered a standard placebo sugar pill.
| Study group | Role | What they receive |
|---|---|---|
| Use of oral quercetin to improve human microvascular function | Experimental | Quercetin is a non-FDA approved, over-the-counter supplement that has been shown to improve oxidative capacity in blood vessels. Receives: Dietary Supplement: Quercetin (dietary supplement) |
| Placebo | Placebo comparator | A placebo will be administered for 30 days followed by assessment of the subject's microvascular function. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood vessel dilation
Peripheral microvascular dilation in response to acetylcholine, L-NAME, and sodium nitroprusside infusions will be measured using laser Doppler flowmetry with microdialysis.
Measured: 2 hours
Secondary outcomes (1)
Change in Perfused Vessel Density
Total vessel density (TVD) will be calculated using the DeBacker Score manual analysis on all images that have a minimum microcirculation image quality score (MIQS) of 10. Perfused vessel density (PVD) will be calculated by multiplying total vessel density (TVD) x proportion of perfused vessels (PPV%).
Measured: 0.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study startJul 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular DysfunctionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to receive the supplement quercetin or placebo for 30 days to determine its effect on microvascular function.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie K. Freed, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683534
- Sponsor's protocol ID
- PRO00053081
- Status last verified
- Apr 2026
- First submitted
- 8 Nov 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Quercetin to Increase Resiliency to Palmitic Acid in the Human Microvasculature
- ClinicalTrials.gov ID
- NCT06683534
- Acronym / sponsor ID
- PRO00053081
- Conditions
- Microvascular Dysfunction, Microvasculature, Cardiovascular Diseases, Cardiovascular Diseases (CVD), Microvascular Health, Obesity and Overweight
- Keywords
- Obesity, Supplement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 Nov 2024 (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 goal of this study is to learn how a supplement Quercetin can affect microvascular function.
Participants will:
- give two blood draws of 5 mL each
- have a camera placed under the tongue to take pictures of blood vessels
- have 2 laser Doppler microdialysis catheters placed on the forearm to monitor blood vessels before and after local drug infusion
Researchers will compare blood vessel function of those who take estrogen supplements to those who do not.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to receive the supplement quercetin or placebo for 30 days to determine its effect on microvascular function.
| Arm | Type | Receives |
|---|---|---|
| Use of oral quercetin to improve human microvascular function | Experimental | Dietary Supplement: Quercetin (dietary supplement)Quercetin is a non-FDA approved, over-the-counter supplement that has been shown to improve oxidative capacity in blood vessels. |
| Placebo | Placebo comparator | Drug: PlaceboA placebo will be administered for 30 days followed by assessment of the subject's microvascular function. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Obesity (BMI>30)
- Aged 18-40 years
- English Speaking
Key exclusion criteria (6 listed)
- BMI>60
- Resting SBP ≥180 mmHg or DBP ≥ 110mmHg
- Pregnancy or breastfeeding.
- Prior history of myocardial infarction
- Diagnosis of more than 1 risk factor for coronary artery disease (active smoker, diabetes mellitus- type 1 or 2, congestive heart failure, hyperlipidemia, hypertension)
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 |
|---|---|---|
| Quercetin (dietary supplement)Quercetin will be provided to take one Quercetin per day for 30 days to look for differences in microvascular function. | Dietary supplement | Use of oral quercetin to improve human microvascular function |
| PlaceboSubjects randomized to receive placebo will be administered a standard placebo sugar pill. | Drug | Placebo |
Primary outcome
Change in blood vessel dilation
Time frame: 2 hours
Peripheral microvascular dilation in response to acetylcholine, L-NAME, and sodium nitroprusside infusions will be measured using laser Doppler flowmetry with microdialysis.
1 secondary outcome
Change in Perfused Vessel Density
Time frame: 0.5 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quercetin (dietary supplement) in people with Microvascular Dysfunction and Microvasculature, run by Medical College of Wisconsin 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 29 Apr 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia A Vogt (4149552348, jvogt@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood vessel dilation (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.