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NCT05107869 Clinical Trial

Effect of Plasma Ceramides on Peripheral Vascular Function

Endothelial Dysfunction Clinical Trial

Official title:
Effect of Plasma Ceramides on Peripheral Vascular Function

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05107869
Other study ID # 00041566
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date December 31, 2027

Study information
Verified date May 2023
Source Medical College of Wisconsin
Contact Julie K. Freed, MD, PhD
Phone 414-955-7487
Email jfreed@mcw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 31, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• High Saturated Fat
High saturated fat meal

Locations
Country Name City State
United States Froedtert Hospital Wauwatosa Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Cardiovascular Conductance Use laser Doppler flowmetry to measure blood flow 6 hours
Primary Endothelial-Dependent Total Vessel Density Use a microscope (CytoCam) to look at blood vessels 6 hours
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