Targeting Trimethylamine N-Oxide for Cardiovascular Healt... | NCT06043531

Studies
Targeting Trimethylamine N-Oxide for Cardiovascular Health In Liver Transplant Recipients

NCT06043531

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

Jan 22, 2026Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Liver Transplant

Interventions

Experimental: EVOO

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 18, 2024Actual

Primary Completion Date

Oct 25, 2024Actual

Completion Date

Oct 25, 2024Actual

First Submitted Date

Sep 12, 2023

First Submission Date that Met QC Criteria

Sep 12, 2023

First Posted Date

Sep 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2026

Last Update Posted Date

Jan 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Despite medical and surgical advances, long-term survival in liver transplant (LT) recipients is compromised by an increased risk of cardiovascular disease (CVD) after transplant, the mechanisms of which are still not fully understood. TMAO is an attractive therapeutic target to improve vascular health and diastolic function toward preventing CVD in LT patients. Therefore, the purpose of this study is to better understand the role of TMAO in cardiovascular dysfunction patients with chronic kidney disease.

Detailed Description

Despite medical and surgical advances, long-term survival in liver transplant (LT) recipients is compromised by an increased risk of cardiovascular disease (CVD) after transplant, the mechanisms of which are still not fully understood. Following LT, patients have an increased incidence of atherosclerotic CVD. Notably, atherosclerotic CVD is an established risk factor for diastolic dysfunction and incident heart failure with preserved ejection fraction (HFpEF). There is a critical need to better understand the biological mechanisms of LT related vascular dysfunction and establish targeted interventions that will reduce the risk of CVD in this patient population. In the general population, there is strong epidemiological evidence linking high TMAO levels with atherosclerotic CVD and heart failure, and that it can modulated rapidly by diet within two weeks. Therefore, the purpose of this study is to better understand the role of TMAO in cardiovascular dysfunction patients with chronic kidney disease.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EVOO supplementation	Experimental	50g/day, dietary supplementation Extra Virgin Olive Oil (EVOO)	Other: Experimental: EVOO
Standard of Care	No Intervention	Standard of care control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental: EVOO	Other	Subjects will consume 50g of cold pressed EVOO per day for 28 days.	EVOO supplementation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum TMAO	Serum TMAO levels will be assessed by nuclear magnetic resonance (NMR)	Change from baseline at four weeks

Secondary Outcomes

Measure	Description	Time Frame
Conduit artery endothelial function changes	Conduit artery endothelial function assessed by flow mediated dilation	Change from baseline at four weeks
Microvascular function change	Skin blood flow response to local heating measured by laser doppler flowmetry

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged > 18 years
Speak and understand English
Have received and LT

Exclusion Criteria:

Acute cellular or chronic rejection within 3 months
Post-LT liver or non-liver related malignancy
Active viral hepatitis (B or C) or autoimmune hepatitis
Untreated biliary strictures or vascular complications (e.g. hepatic artery thrombosis)
Poorly controlled diabetes (HbA1c >8.5%)
Relapse of alcohol use after LT
Follow a vegetarian or vegan diet
Current pregnancy
Unable to provide informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Danielle Kirkman	Virginia Commonwealth University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University		Richmond	Virginia	23298	United States