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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Lipid Disorder
• Lipid Metabolism Disorders
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

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