EVOO for Liver Transplant Recipients

Overseen By Patrice Wiecek

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Malignancy, Hepatitis, Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is extra virgin olive oil (EVOO) safe for humans?

Extra virgin olive oil (EVOO) is generally considered safe for human consumption and has been shown to have antioxidant properties that may protect the liver. Studies in animals suggest it can reduce liver fat and improve insulin sensitivity, although it may not alleviate liver inflammation or fibrosis. ^{1 2 3 4 5}

How does extra virgin olive oil (EVOO) treatment differ from other treatments for liver transplant recipients?

Extra virgin olive oil (EVOO) is unique because it has strong antioxidant properties that help protect the liver from oxidative stress, which is damage caused by free radicals. Unlike other treatments, EVOO contains high levels of phenolic compounds, such as hydroxytyrosol, which may contribute to its protective effects on the liver. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment EVOO for liver transplant recipients?

Research shows that extra virgin olive oil (EVOO) can help protect the liver from damage in mice with fatty liver disease and improve liver health in people following a Mediterranean diet. This suggests that EVOO might also be beneficial for liver transplant recipients. ^{4 8 9 10 11}

Who Is on the Research Team?

Danielle Kirkman, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak and understand English and have received a liver transplant. It aims to explore cardiovascular health in these patients.

Inclusion Criteria

Speak and understand English

Have received and LT

I am older than 18 years.

Exclusion Criteria

Follow a vegetarian or vegan diet

Relapse of alcohol use after LT

Current pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dietary supplementation with 50g/day of Extra Virgin Olive Oil (EVOO) or standard of care

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for changes in frailty, diastolic function, arterial hemodynamics, microvascular function, conduit artery endothelial function, serum TMAO levels, and quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EVOO

Trial Overview The study tests the effects of Extra Virgin Olive Oil (EVOO) on heart health in liver transplant recipients, focusing on TMAO levels—a factor linked to cardiovascular disease.

How Is the Trial Designed?

Group I: EVOO supplementation Experimental Treatment 1 Intervention

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

Group II: Standard of Care Active Control 1 Intervention

Standard of care control

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Published Research Related to This Trial

In a study involving 70 rats, those receiving total parenteral nutrition (TPN) with olive oil showed significant improvements in liver tissue regeneration after hepatic resection, indicated by increased relative liver weight and enhanced mitotic activity.

Olive oil's antioxidant properties contributed to reduced lipid peroxidation and near-normal liver function parameters, suggesting that olive oil may be a beneficial component in TPN for promoting liver recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of olive oil based emulsions as an alternative to soybean oil based emulsions in total parenteral nutrition and their effects on liver regeneration following hepatic resection in rats. Ok, E., Yilmaz, Z., Karaküçük, I., et al.[2017]

In a study using C57BL/6J mice, replacing lard with extra virgin olive oil (EVOO) in a high-fat diet significantly reduced liver damage and inflammation associated with nonalcoholic fatty liver disease (NAFLD) over a 24-week period.

EVOO improved the mice's plasma lipid profiles, reduced body weight, and decreased inflammatory markers, suggesting that EVOO may have protective effects against high-fat diet-induced liver damage through anti-inflammatory mechanisms and beneficial changes in liver lipid composition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An extra virgin olive oil rich diet intervention ameliorates the nonalcoholic steatohepatitis induced by a high-fat "Western-type" diet in mice. Jurado-Ruiz, E., Varela, LM., Luque, A., et al.[2022]

A Mediterranean diet supplemented with nuts or extra virgin olive oil (EVOO) can help slow the progression of non-alcoholic fatty liver (NAFL) in older adults, as shown in a study of 276 participants over 6 years.

Participants on the Mediterranean diet with nuts experienced a significant reduction in fatty liver index (FLI) and a lower increase in body mass index (BMI) compared to those on a low-fat control diet, suggesting this diet may be effective for preventing and treating NAFL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in fatty liver index after consuming a Mediterranean diet: 6-year follow-up of the PREDIMED-Malaga trial. Cueto-Galán, R., Barón, FJ., Valdivielso, P., et al.[2018]

In a study involving 10 patients with chronic hepatitis B, supplementation with evening primrose oil (4 g daily for 12 months) did not lead to any significant improvement in liver damage indicators compared to a placebo group.

The results suggest that dietary supplementation with this specific dose of essential fatty acids is unlikely to provide any benefit for patients suffering from chronic hepatitis B.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential fatty acid supplementation in chronic hepatitis B. Jenkins, AP., Green, AT., Thompson, RP.[2021]

Pretreatment with L-glycine significantly reduced liver injury and improved liver function in a rat model undergoing major hepatectomy, as evidenced by lower levels of liver enzymes and bilirubin compared to controls.

In contrast, pretreatments with silibinin and high doses of alpha-tocopherol were less effective or even showed adverse effects, highlighting glycine as a potentially beneficial protective agent for liver donors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycine pretreatment ameliorates liver injury after partial hepatectomy in the rat. Benko, T., Frede, S., Gu, Y., et al.[2019]

In a study involving male C57BL/6J mice, supplementation with n-3 long-chain polyunsaturated fatty acids (LCPUFA) and extra virgin olive oil (EVOO) for 12 weeks significantly reduced liver fat accumulation and improved liver function in mice fed a high-fat diet.

The combination of n-3 LCPUFA and EVOO not only exhibited antioxidant and anti-inflammatory effects but also improved insulin sensitivity and restored the balance between fat breakdown and fat production in the liver, suggesting its potential as a therapeutic option for treating fatty liver disease in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-steatotic effects of an n-3 LCPUFA and extra virgin olive oil mixture in the liver of mice subjected to high-fat diet. Valenzuela, R., Espinosa, A., Llanos, P., et al.[2016]

Extra virgin olive oil (EVOO) significantly reduces oxidative stress markers, such as isoprostanoids and cholesterol oxidation products, in rats, indicating its protective effects against oxidative damage.

The study identifies hydroxytyrosol conjugated to fatty acids (HT-FA) as a key component in EVOO that contributes to its high antioxidant activity, although liver toxicity from carbon tetrachloride (CCl4) was not mitigated by the diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extra Virgin Olive Oil Reduced Polyunsaturated Fatty Acid and Cholesterol Oxidation in Rodent Liver: Is This Accounted for Hydroxytyrosol-Fatty Acid Conjugation? Lee, YY., Crauste, C., Wang, H., et al.[2018]

In a study of 2436 participants, higher daily consumption of extra virgin olive oil (EVOO) was linked to a lower prevalence of non-alcoholic fatty liver disease (NAFLD), with significant risk reductions observed especially in overweight and obese individuals.

Specifically, those consuming high amounts of EVOO (>37 g/day) had a 26% relative risk reduction for NAFLD compared to those with low consumption (0-24 g/day), highlighting the potential health benefits of EVOO in managing liver health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Extra Virgin Olive Oil Consumption Is Linked to a Lower Prevalence of NAFLD with a Prominent Effect in Obese Subjects: Results from the MICOL Study. Tedesco, CC., Bonfiglio, C., Notarnicola, M., et al.[2023]

In a study using female Ldlr-/-.Leiden mice, diets high in extra-virgin olive oil (EVOO) improved body weight and insulin sensitivity but did not reduce liver inflammation or fibrosis associated with non-alcoholic fatty liver disease (NAFLD).

The EVOO diets led to increased LDL-cholesterol and liver collagen content, indicating potential profibrotic effects, despite their benefits in weight management and insulin sensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extra virgin olive oil improved body weight and insulin sensitivity in high fat diet-induced obese LDLr-/-.Leiden mice without attenuation of steatohepatitis. Álvarez-Amor, L., Sierra, AL., Cárdenas, A., et al.[2021]

Incorporating 1% diallyl sulfide (DAS) into extra virgin olive oil (EVOO) enhances its antioxidant properties, showing superior free radical scavenging activities compared to regular EVOO or DAS alone.

In a mouse model of acute liver injury, DAS-rich EVOO significantly improved liver function by normalizing serum ALT and AST levels and reducing inflammation, indicating its potential as a hepatoprotective functional food.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antioxidant and protective effects of extra virgin olive oil incorporated with diallyl sulfide against CCl4-induced acute liver injury in mice. Habibi, E., Baâti, T., Njim, L., et al.[2021]

In a meta-analysis of 6 randomized controlled trials involving 306 postoperative patients, the new lipid emulsion SMOFlipid20% showed lower levels of hepatic enzymes compared to traditional soybean-based emulsions, indicating reduced toxicity.

SMOFlipid20% also resulted in lower levels of low-density lipoprotein triglycerides and C-reactive protein compared to Lipoven20%, suggesting better metabolic outcomes, while no significant differences in adverse events or hospital stay length were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a new parenteral lipid emulsion (SMOF) for surgical patients: a systematic review and meta-analysis of randomized controlled trials. Tian, H., Yao, X., Zeng, R., et al.[2018]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Use of olive oil based emulsions as an alternative to soybean oil based emulsions in total parenteral nutrition and their effects on liver regeneration following hepatic resection in rats. [2017]

2. Germany pubmed.ncbi.nlm.nih.gov

An extra virgin olive oil rich diet intervention ameliorates the nonalcoholic steatohepatitis induced by a high-fat "Western-type" diet in mice. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

Changes in fatty liver index after consuming a Mediterranean diet: 6-year follow-up of the PREDIMED-Malaga trial. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Essential fatty acid supplementation in chronic hepatitis B. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Glycine pretreatment ameliorates liver injury after partial hepatectomy in the rat. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Anti-steatotic effects of an n-3 LCPUFA and extra virgin olive oil mixture in the liver of mice subjected to high-fat diet. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Extra Virgin Olive Oil Reduced Polyunsaturated Fatty Acid and Cholesterol Oxidation in Rodent Liver: Is This Accounted for Hydroxytyrosol-Fatty Acid Conjugation? [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

High Extra Virgin Olive Oil Consumption Is Linked to a Lower Prevalence of NAFLD with a Prominent Effect in Obese Subjects: Results from the MICOL Study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Extra virgin olive oil improved body weight and insulin sensitivity in high fat diet-induced obese LDLr-/-.Leiden mice without attenuation of steatohepatitis. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Antioxidant and protective effects of extra virgin olive oil incorporated with diallyl sulfide against CCl4-induced acute liver injury in mice. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a new parenteral lipid emulsion (SMOF) for surgical patients: a systematic review and meta-analysis of randomized controlled trials. [2018]