Palmitic Acid and Human Microvascular Function

Phase 2

Not yet recruiting

• Conditions: Microvascular Dysfunction; Microvasculature; Cardiovascular Diseases; Cardiovascular Diseases (CVD); Microvascular Health; Obesity and Overweight
• Interventions: Dietary Supplement: Quercetin (dietary supplement); Drug: Placebo

• Registration Number: NCT06683534
• Lead Sponsor: Medical College of Wisconsin

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-08
• Study First Submitted QC: 2024-11-08
• Study First Posted: 2024-11-12
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30
• Study Start: 2025-10
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Obesity (BMI>30)
• Aged 18-60 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Use of oral quercetin to improve human microvascular function	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	A placebo will be administered for 30 days followed by assessment of the subject's microvascular function.

Primary Outcome Measures

Name	Time	Method
Change in blood vessel dilation	2 hours	Peripheral microvascular dilation in response to acetylcholine, L-NAME, and sodium nitroprusside infusions will be measured using laser Doppler flowmetry with microdialysis.

Secondary Outcome Measures

Name	Time	Method
Change in Perfused Vessel Density	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%).

Trial Locations

Locations (1)

Froedtert Hospital; 🇺🇸 Wauwatosa, Wisconsin, United States