Targeting Trimethylamine N-Oxide for Cardiovascular Health In Liver Transplant Recipients
1 other identifier
interventional
19
1 country
1
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.
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 Jan 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
January 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2024
CompletedJanuary 22, 2026
January 1, 2026
9 months
September 12, 2023
January 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Serum TMAO
Serum TMAO levels will be assessed by nuclear magnetic resonance (NMR)
Change from baseline at four weeks
Secondary Outcomes (6)
Conduit artery endothelial function changes
Change from baseline at four weeks
Microvascular function change
Change from baseline at four weeks
Arterial hemodynamics changes
Change from baseline at four weeks
Diastolic Function change
Change from baseline at four weeks
Frailty outcome hanges
Change from baseline at four weeks
- +1 more secondary outcomes
Study Arms (2)
EVOO supplementation
EXPERIMENTAL50g/day, dietary supplementation Extra Virgin Olive Oil (EVOO)
Standard of Care
NO INTERVENTIONStandard of care control
Interventions
Subjects will consume 50g of cold pressed EVOO per day for 28 days.
Eligibility Criteria
You may qualify if:
- Aged \> 18 years
- Speak and understand English
- Have received and LT
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Danielle Kirkman
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2023
First Posted
September 21, 2023
Study Start
January 18, 2024
Primary Completion
October 25, 2024
Study Completion
October 25, 2024
Last Updated
January 22, 2026
Record last verified: 2026-01