Effect of Plasma Ceramides on Peripheral Vascular Function

Not Applicable

Active, not recruiting

• Conditions: Peripheral Vascular Disease; Endothelial Dysfunction; Lipid Disorder
• Interventions: Other: High Saturated Fat

• Registration Number: NCT05107869
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

The goal of this clinical trial is to determine the effect of elevated plasma ceramides on peripheral vascular function. Subjects will consume a high fat meal consisting of long chain fatty acids (to increase plasma ceramides) or medium chain fatty acids (control). Subjects' vascular function will be assessed with laser Doppler flowmetry to measure their artery function and with the CytoCam device to assess their peripheral microvascular endothelial function.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-04
• Study Start: 2023-05-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Health adults aged 18-40 years
2. English-speaking only
3. Not pregnant

Exclusion Criteria

1. Healthy individuals under 18 years or over 40 years of age
2. Non-English speaking
3. Pregnant individuals
4. Heart rate <60 or >100
5. Systolic blood pressure <100 or >160
6. Subjects with visible open sores or wounds in mouth
7. Lactose intolerant or allergy to dairy products
8. Diabetes Mellitus
9. Coronary Artery Disease
10. High blood pressure
11. High cholesterol
12. Heart failure
13. Current tobacco use
14. Chemotherapy within the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Long Chain Fatty Acid High Fat Meal	High Saturated Fat	This arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a long chain fatty acid high fat meal.
Medium Chain Fatty Acid High Fat Meal	High Saturated Fat	This arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a medium chain fatty acid high fat meal.

Primary Outcome Measures

Name	Time	Method
Endothelial-Dependent Total Vessel Density	6 hours	Use a microscope (CytoCam) to look at blood vessels
Percentage of Cardiovascular Conductance	6 hours	Use laser Doppler flowmetry to measure blood flow

Trial Locations

Locations (1)

Froedtert Hospital; 🇺🇸 Wauwatosa, Wisconsin, United States