Back to resultsEffect of Plasma Ceramides on Peripheral Vascular Function
Primary Purpose
Peripheral Vascular Disease, Lipid Disorder, Endothelial Dysfunction
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Saturated Fat
Sponsored by
About this trial
This is an interventional basic science trial for Peripheral Vascular Disease focused on measuring Ceramide, Endothelium
Eligibility Criteria
Inclusion Criteria:
- Health adults aged 18-40 years
- English-speaking only
- Not pregnant
Exclusion Criteria:
- Health individuals under 18 years or over 40 years of age
- Non-English speaking
- Pregnant individuals
- Individuals on erectile dysfunction medications within the last 24 hours
- Heart rate <60 or >100
- Systolic blood pressure <100 or >160
- Subjects with visible open sores or wounds in mouth
- Subjects with severe environmental allergies requiring medication as well as subjects with allergies to medications
- Subjects taking nitrates or vasodilating medications
- Lactose intolerant or allergy to dairy products.
Sites / Locations
- Froedtert HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Medium Chain Fatty Acid High Fat Meal
Long Chain Fatty Acid High Fat Meal
Arm Description
This arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a medium chain fatty acid high fat meal.
This arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a long chain fatty acid high fat meal.
Outcomes
Primary Outcome Measures
Percentage of Cardiovascular Conductance
Use laser Doppler flowmetry to measure blood flow
Endothelial-Dependent Total Vessel Density
Use a microscope (CytoCam) to look at blood vessels
Secondary Outcome Measures
Full Information
NCT ID
NCT05107869
First Posted
October 4, 2021
Last Updated
May 15, 2023
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT05107869
Brief Title
Effect of Plasma Ceramides on Peripheral Vascular Function
Official Title
Effect of Plasma Ceramides on Peripheral Vascular Function
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease, Lipid Disorder, Endothelial Dysfunction
Keywords
Ceramide, Endothelium
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Medium Chain Fatty Acid High Fat Meal
Arm Type
Active Comparator
Arm Description
This arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a medium chain fatty acid high fat meal.
Arm Title
Long Chain Fatty Acid High Fat Meal
Arm Type
Experimental
Arm Description
This arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a long chain fatty acid high fat meal.
Intervention Type
Other
Intervention Name(s)
High Saturated Fat
Intervention Description
High saturated fat meal
Primary Outcome Measure Information:
Title
Percentage of Cardiovascular Conductance
Description
Use laser Doppler flowmetry to measure blood flow
Time Frame
6 hours
Title
Endothelial-Dependent Total Vessel Density
Description
Use a microscope (CytoCam) to look at blood vessels
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Health adults aged 18-40 years
English-speaking only
Not pregnant
Exclusion Criteria:
Healthy individuals under 18 years or over 40 years of age
Non-English speaking
Pregnant individuals
Heart rate <60 or >100
Systolic blood pressure <100 or >160
Subjects with visible open sores or wounds in mouth
Lactose intolerant or allergy to dairy products
Diabetes Mellitus
Coronary Artery Disease
High blood pressure
High cholesterol
Heart failure
Current tobacco use
Chemotherapy within the last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie K. Freed, MD, PhD
Phone
414-955-7487
Email
jfreed@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shona Hang, MSPH
Phone
414-955-2348
Email
shang@mcw.edu
Facility Information:
Facility Name
Froedtert Hospital
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shona
Phone
414-955-2348
Email
shang@mcw.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effect of Plasma Ceramides on Peripheral Vascular Function
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