Palmitic Acid and Human Microvascular Function

NCT06683534 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: PRO00053081
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Obesity; Supplement

Outcome Measures

Primary Outcomes (1)

• 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.

  2 hours

Secondary Outcomes (1)

• Change in Perfused Vessel Density

  0.5 hours

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

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.

Use of oral quercetin to improve human microvascular function

Placebo DRUG

Subjects randomized to receive placebo will be administered a standard placebo sugar pill.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Obesity (BMI\>30)
• Aged 18-40 years
• English Speaking

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Wauwatosa, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Obesity; Overweight

Interventions

Quercetin; Dietary Supplements

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Julia A Vogt

CONTACT

4149552348; jvogt@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Vice Chair

Model Details: Subjects will be randomized to receive the supplement quercetin or placebo for 30 days to determine its effect on microvascular function.

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)