Effect of Plasma Ceramides on Peripheral Vascular Function
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2021
CompletedFirst Posted
Study publicly available on registry
November 4, 2021
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedJune 15, 2026
June 1, 2026
2.3 years
October 4, 2021
June 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Cardiovascular Conductance
Use laser Doppler flowmetry to measure blood flow
6 hours
Endothelial-Dependent Total Vessel Density
Use a microscope (CytoCam) to look at blood vessels
6 hours
Study Arms (2)
Medium Chain Fatty Acid High Fat Meal
ACTIVE COMPARATORThis arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a medium chain fatty acid high fat meal.
Long Chain Fatty Acid High Fat Meal
EXPERIMENTALThis arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a long chain fatty acid high fat meal.
Interventions
High saturated fat meal
Eligibility Criteria
You may qualify if:
- Health adults aged 18-40 years
- English-speaking only
- Not pregnant
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Froedtert Hospital
Wauwatosa, Wisconsin, 53226, United States
Related Publications (7)
Freed JK, Beyer AM, LoGiudice JA, Hockenberry JC, Gutterman DD. Ceramide changes the mediator of flow-induced vasodilation from nitric oxide to hydrogen peroxide in the human microcirculation. Circ Res. 2014 Aug 15;115(5):525-32. doi: 10.1161/CIRCRESAHA.115.303881. Epub 2014 Jun 11.
PMID: 24920698RESULTAkhiyat N, Vasile V, Ahmad A, Sara JD, Nardi V, Lerman LO, Jaffe A, Lerman A. Plasma Ceramide Levels Are Elevated in Patients With Early Coronary Atherosclerosis and Endothelial Dysfunction. J Am Heart Assoc. 2022 Apr 5;11(7):e022852. doi: 10.1161/JAHA.121.022852. Epub 2022 Mar 18.
PMID: 35301857RESULTLemaitre RN, Jensen PN, Hoofnagle A, McKnight B, Fretts AM, King IB, Siscovick DS, Psaty BM, Heckbert SR, Mozaffarian D, Sotoodehnia N. Plasma Ceramides and Sphingomyelins in Relation to Heart Failure Risk. Circ Heart Fail. 2019 Jul;12(7):e005708. doi: 10.1161/CIRCHEARTFAILURE.118.005708. Epub 2019 Jul 12.
PMID: 31296099RESULTHavulinna AS, Sysi-Aho M, Hilvo M, Kauhanen D, Hurme R, Ekroos K, Salomaa V, Laaksonen R. Circulating Ceramides Predict Cardiovascular Outcomes in the Population-Based FINRISK 2002 Cohort. Arterioscler Thromb Vasc Biol. 2016 Dec;36(12):2424-2430. doi: 10.1161/ATVBAHA.116.307497. Epub 2016 Oct 20.
PMID: 27765765RESULTAl-Badri A, Kim JH, Liu C, Mehta PK, Quyyumi AA. Peripheral Microvascular Function Reflects Coronary Vascular Function. Arterioscler Thromb Vasc Biol. 2019 Jul;39(7):1492-1500. doi: 10.1161/ATVBAHA.119.312378. Epub 2019 Apr 25.
PMID: 31018659RESULTPaulus WJ, Tschope C. A novel paradigm for heart failure with preserved ejection fraction: comorbidities drive myocardial dysfunction and remodeling through coronary microvascular endothelial inflammation. J Am Coll Cardiol. 2013 Jul 23;62(4):263-71. doi: 10.1016/j.jacc.2013.02.092. Epub 2013 May 15.
PMID: 23684677RESULTvan de Hoef TP, van Lavieren MA, Damman P, Delewi R, Piek MA, Chamuleau SA, Voskuil M, Henriques JP, Koch KT, de Winter RJ, Spaan JA, Siebes M, Tijssen JG, Meuwissen M, Piek JJ. Physiological basis and long-term clinical outcome of discordance between fractional flow reserve and coronary flow velocity reserve in coronary stenoses of intermediate severity. Circ Cardiovasc Interv. 2014 Jun;7(3):301-11. doi: 10.1161/CIRCINTERVENTIONS.113.001049. Epub 2014 Apr 29.
PMID: 24782198RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Director of Clinical Research
Study Record Dates
First Submitted
October 4, 2021
First Posted
November 4, 2021
Study Start
May 1, 2023
Primary Completion
August 1, 2025
Study Completion
October 1, 2025
Last Updated
June 15, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share