- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06683534
Palmitic Acid and Human Microvascular Function
April 28, 2026 updated by: Julie K. Freed, Medical College of Wisconsin
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Julia A Vogt
- Phone Number: 4149552348
- Email: jvogt@mcw.edu
Study Locations
-
-
Wisconsin
-
Wauwatosa, Wisconsin, United States, 53226
- Froedtert Hospital
-
Principal Investigator:
- Julie Freed, MD, PhD
-
Contact:
- Julia Vogt
- Phone Number: 4149552348
- Email: jvogt@mcw.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Obesity (BMI>30)
- Aged 18-40 years
- English Speaking
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Use of oral quercetin to improve human microvascular function
Quercetin is a non-FDA approved, over-the-counter supplement that has been shown to improve oxidative capacity in blood vessels.
|
Quercetin will be provided to take one Quercetin per day for 30 days to look for differences in microvascular function.
|
|
Placebo Comparator: Placebo
A placebo will be administered for 30 days followed by assessment of the subject's microvascular function.
|
Subjects randomized to receive placebo will be administered a standard placebo sugar pill.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Perfused Vessel Density
Time Frame: 0.5 hours
|
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%).
|
0.5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Study Registration Dates
First Submitted
November 8, 2024
First Submitted That Met QC Criteria
November 8, 2024
First Posted (Actual)
November 12, 2024
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 28, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Overweight
- Obesity
- Cardiovascular Diseases
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Pyrans
- Food
- Diet, Food, and Nutrition
- Physiological Phenomena
- Food and Beverages
- Benzopyrans
- Flavonols
- Flavonoids
- Chromones
- Quercetin
- Dietary Supplements
Other Study ID Numbers
- PRO00053081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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