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

NCT ID: NCT06043531

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2025-12-31

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.

Conditions

Liver Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EVOO supplementation

50g/day, dietary supplementation Extra Virgin Olive Oil (EVOO)

Group Type: EXPERIMENTAL

Experimental: EVOO

Intervention Type: OTHER

Subjects will consume 50g of cold pressed EVOO per day for 28 days.

Standard of Care

Standard of care control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Experimental: EVOO

Subjects will consume 50g of cold pressed EVOO per day for 28 days.

Intervention Type: OTHER

Other Intervention Names

Dietary EVOO

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Kirkman

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Patrice Wiecek

Role: CONTACT

wiecekpj@vcu.edu

(804) 827-1815

Facility Contacts

Danielle Kirkman

Role: primary

dlkirkman@vcu.edu

Patrice Wiecek

Role: backup

wiecekpj@vcu.edu

Other Identifiers

HM20027920

Identifier Type: -

Identifier Source: org_study_id