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?

This trial explores how extra virgin olive oil (EVOO) might improve heart health in individuals who have undergone a liver transplant. Researchers focus on a substance called TMAO, which may link to heart problems in these patients. Participants will either receive EVOO daily or continue with their usual care to determine if EVOO makes a difference. The trial seeks individuals who have had a liver transplant and do not have current liver issues or severe diabetes. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance heart health for liver transplant recipients.

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 there any evidence suggesting that EVOO is likely to be safe for humans?

Research has shown that extra virgin olive oil (EVOO) is generally safe for consumption. Known for its antioxidant properties, it might help protect the liver. Studies suggest that high consumption of EVOO can prevent fatty liver disease, a condition characterized by fat accumulation in the liver.

No major reports of harmful effects from consuming EVOO have emerged in the reviewed studies. Overall, EVOO appears well-tolerated and safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for liver transplant recipients, which typically involves immunosuppressive medications to prevent organ rejection, EVOO (Extra Virgin Olive Oil) offers a novel dietary approach. Researchers are excited because EVOO is rich in antioxidants and anti-inflammatory compounds, which might support liver health and reduce inflammation naturally. This could potentially enhance patient outcomes without the side effects commonly associated with long-term medication use.

What evidence suggests that EVOO might be an effective treatment for cardiovascular disease in liver transplant recipients?

This trial will evaluate the effects of extra virgin olive oil (EVOO) supplementation in liver transplant recipients. Research has shown that EVOO can protect the liver from damage, particularly in cases of fatty liver disease. Studies suggest that high consumption of EVOO can lower the risk of developing fatty liver by improving liver health. EVOO also benefits the heart and blood vessels, which is crucial for individuals with liver transplants. One study found that daily olive oil consumption was linked to a lower risk of death from any cause, indicating it might help people live longer. This is promising because it suggests EVOO might support overall health in liver transplant patients. ^{1 5 6 7 8}

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

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 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 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 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 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 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]

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]

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 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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1756464623004152

Effects of olive oil on hepatic steatosis and liver enzymes Olive oil may help alleviate hepatic steatosis and modulate liver enzyme levels. Olive oil with higher polyphenols may be superior.

2. withpower.com withpower.com/trial/phase-transplantation-liver-8-2023-338c8

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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10647576/

High Extra Virgin Olive Oil Consumption Is Linked to a ... Our data suggest that a high intake of EVOO prevents fatty liver, and interestingly, the risk of the disease seems to reach a maximum decrease ...

4. researchgate.net researchgate.net/publication/393296240_Effect_of_Extra_Virgin_Olive_Oil_Supplementation_on_Gut-Derived_Metabolite_Trimethylamine-N-Oxide_and_Vascular_Function_in_Liver_Transplant_Recipients

Effect of Extra Virgin Olive Oil Supplementation on Gut ... Every 25 g/day OO intake was associated with an 11% lower relative risk of all‐cause mortality (95% CI: 0.85, 0.93). Additionally, each 10 g/day ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0333698

Exosomes combined with extra virgin olive oil reduces ... The combined effect of exosomes derived from MSCs, and extra virgin olive oil had a much improved effect on the reduction of lipid accumulation in the liver ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7607500/

NAFLD and liver transplantation: Disease burden, current ... Moreover, data on re-LT outcomes in patients with NASH seem to suggest lower survival rates at 5-years after re-LT when compared to other aetiologies.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12558531/

Exosomes combined with extra virgin olive oil reduces ... In the present study we aimed to combine the beneficial effects of Extra Virgin Olive Oil (EVOO) and MSCs-Exo on a model of high-fat-diet ...

8. mdpi.com mdpi.com/2072-6643/15/21/4673

High Extra Virgin Olive Oil Consumption Is Linked to a ... Our data suggest that a high intake of EVOO prevents fatty liver, and interestingly, the risk of the disease seems to reach a maximum decrease with an 85 g ...