Improving heart health in liver transplant recipients by targeting TMAO levels
Targeting Trimethylamine N-Oxide for Cardiovascular Health In Liver Transplant Recipients
This study is testing if changing the diet of liver transplant recipients by adding extra virgin olive oil can lower TMAO levels and improve their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06043531 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the role of trimethylamine N-oxide (TMAO) in cardiovascular dysfunction among liver transplant recipients. It focuses on understanding how elevated TMAO levels may contribute to the increased risk of cardiovascular disease in these patients. The intervention involves dietary modifications, specifically the use of extra virgin olive oil (EVOO), to potentially lower TMAO levels and improve vascular health. By exploring this relationship, the study seeks to establish targeted interventions that could enhance long-term cardiovascular outcomes for liver transplant patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have received a liver transplant and can communicate in English.
Not a fit: Patients with recent acute rejection, active malignancies, or those following a vegetarian or vegan diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health and reduced risk of heart disease in liver transplant recipients.
How similar studies have performed: While the specific approach of targeting TMAO in liver transplant recipients is novel, there is existing evidence linking TMAO to cardiovascular disease in the general population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Danielle Kirkman — Virginia Commonwealth University
- Study coordinator: Patrice Wiecek
- Email: wiecekpj@vcu.edu
- Phone: (804) 827-1815
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.