Effect of Plasma Ceramides on Peripheral Vascular Function

NCT05107869 | Completed

• 1 other identifier: 00041566
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 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.

Conditions

Peripheral Vascular Disease; Lipid Disorder; Endothelial Dysfunction

Keywords

Ceramide; Endothelium

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 COMPARATOR

This arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a medium chain fatty acid high fat meal.

Other: High Saturated Fat

Long Chain Fatty Acid High Fat Meal

EXPERIMENTAL

This arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a long chain fatty acid high fat meal.

Other: High Saturated Fat

Interventions

High Saturated Fat OTHER

High saturated fat meal

Long Chain Fatty Acid High Fat Meal; Medium Chain Fatty Acid High Fat Meal

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Wauwatosa, Wisconsin, 53226, United States

Location

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: 24920698 BACKGROUND

• Akhiyat 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: 35301857 BACKGROUND

• Lemaitre 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: 31296099 BACKGROUND

• Havulinna 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: 27765765 BACKGROUND

• Al-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: 31018659 BACKGROUND

• Paulus 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: 23684677 BACKGROUND

• van 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: 24782198 BACKGROUND

MeSH Terms

Conditions

Peripheral Vascular Diseases; Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

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: May 7, 2025
• Study Completion: May 7, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)