Dietary Intervention for Post-Liver Transplant Health

Overseen By Kymberly Watt, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Hepatocellular carcinoma, Uncontrolled diabetes, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a Mediterranean diet can help maintain health after a liver transplant. The diet emphasizes fruits, vegetables, whole grains, nuts, and lean proteins such as fish and poultry. It aims to prevent weight gain, enhance heart health, and prevent the development of fatty liver disease. Individuals with a liver transplant and a BMI of 25 or more might be suitable candidates. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance post-transplant health for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Mediterranean Diet is safe for post-liver transplant patients?

Research has shown that a Mediterranean diet is safe and easy to follow for people who have had a liver transplant. This diet can help reduce the risk of liver issues like NAFLD (non-alcoholic fatty liver disease) and NASH (non-alcoholic steatohepatitis), which are types of liver damage. One study found that people who followed a Mediterranean diet after their liver transplant had a 100% survival rate at one and three years, and an 85.7% survival rate at five years. These findings suggest that the diet is not only safe but may also support long-term health. Overall, the Mediterranean diet is considered a safe and healthy option for those recovering from a liver transplant. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring the modified Mediterranean diet for post-liver transplant health because it offers a holistic approach focusing on dietary patterns rather than just medication. Unlike the standard of care, which includes a general nutrition class and lifestyle counseling, this intervention involves personalized one-on-one sessions with a dietician. These sessions emphasize consuming more fruits, vegetables, whole grains, beans, nuts, and lean proteins, aligning with heart-healthy principles. The diet's emphasis on low salt and moderate monounsaturated fats could lead to improved overall health and potentially reduce transplant-related complications.

What evidence suggests that the Mediterranean Diet is effective for post-liver transplant health?

Research has shown that a structured Mediterranean diet can benefit individuals who have undergone a liver transplant. This trial includes a treatment arm where participants follow a structured Modified Mediterranean Diet, emphasizing fruits, vegetables, whole grains, and healthy fats like olive oil. Studies have found that this diet can lower the risk of heart disease and help prevent weight gain after a liver transplant. Some participants on this diet demonstrated better long-term heart health. Additionally, the Mediterranean diet is associated with a lower risk of developing fatty liver disease. These findings suggest that the Mediterranean diet may be a good option for maintaining health after a liver transplant. ^{2 6 7 8 9}

Who Is on the Research Team?

Kymberly Watt, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had a liver transplant, have a BMI ≥ 25 adjusted for fluid in the belly (ascites), and good graft function. It's not for those with certain types of liver cancer, multiple organ transplants, heavy protein loss in urine, uncontrolled diabetes, pregnancy or plans to become pregnant soon, history of weight-loss surgery, untreated post-transplant complications or conditions that make it unsafe to follow a special diet.

Inclusion Criteria

My liver is functioning well, with normal bilirubin levels and clear blood vessels.

My BMI is 25 or higher, adjusted for fluid in my abdomen.

I am 18 or older and am getting my first liver transplant.

Exclusion Criteria

Pregnancy or planning on pregnancy in the next year

I do not have any health conditions that would make it unsafe for me to join a nutrition study.

I have received transplants for more than one organ.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the Dietary Intervention arm or the Standard of Care arm and followed for dietary and lifestyle interventions

12 months

Regular visits for dietary counseling and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Mediterranean Diet

Trial Overview The study is testing how following a structured Mediterranean diet affects people after they've had a liver transplant. The goal is to see if this diet can prevent weight gain and promote heart health while also preventing fatty liver disease.

How Is the Trial Designed?

Group I: Behavioral: Structured Modified Mediterranean Diet Experimental Treatment 1 Intervention

Subjects will participate in a one-on-one counselling session with a dietician, as opposed to attending the standardized Transplant Nutrition class. Counselling will be provided on the elements of the modified Mediterranean diet which emphasizes consumption of fruits, vegetables, whole grains, beans and nuts, in addition to low salt, moderate amounts of lean protein (primarily fish and poultry) in addition to low to moderate quantities of monounsaturated fats.

Group II: Standard of Care Group Active Control 1 Intervention

Subjects will participate in a standardized Transplant Nutrition class between day 21-40 as per institutional protocol and will be counseled as per the Mayo Clinic standard of care vis a vis dietary intervention, standard aerobic and resistance exercise recommendations (consistent with AASLD guidelines) and other lifestyle interventions.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Clinicians involved in the long-term management of kidney and liver transplant recipients do not routinely incorporate the Mediterranean dietary pattern into post-transplant nutrition care, citing competing clinical priorities and a lack of consistent nutrition advice.

There is significant variation in clinicians' knowledge and acceptance of the Mediterranean diet, which affects their ability to provide patient-centered nutrition recommendations, highlighting the need for targeted intervention strategies to promote this dietary approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Qualitative Study of Clinician Barriers and Enablers to Implementing the Mediterranean Dietary Pattern with Kidney and Liver Transplant Recipients. McLaren-Hedwards, T., Hickman, IJ., Campbell, KL., et al.[2022]

In a study of 37 young adults who had undergone liver transplantation, a significant number (54%) were found to be osteopenic, indicating that bone health is a concern in this population, especially since many were also overweight or obese.

The research highlighted a strong correlation between lean body mass and bone mineral density, particularly in females, suggesting that maintaining muscle mass could be important for preserving bone health after liver transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of nutrition and body composition on bone density after liver transplantation. Khan, KM., Mulia, S., Kaul, R., et al.[2015]

Liver transplant recipients (LTR) consume a high-energy diet averaging 1998 kcal per day, but their nutritional quality is poor, with low intake of fruits, vegetables, and fiber, which are essential for cardiovascular health.

In the first month post-transplant, LTR do not meet their energy and protein requirements, but their intake stabilizes over time, indicating a long-term trend of high fat and low-quality dietary choices that do not align with cardiovascular disease prevention guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Intake after Liver Transplant: Systematic Review and Meta-Analysis. Spillman, LN., Madden, AM., Richardson, H., et al.[2023]

In the first year after liver transplantation, patients gained an average of 7.3% of their body weight, with the prevalence of overweight or obesity increasing from 53% to 77%.

By 6 months post-transplant, 65% of patients experienced altered glucose metabolism, indicating significant metabolic dysfunction, despite most patients reporting low depressive feelings and good self-esteem.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in dietary patterns and body composition within 12 months of liver transplantation. McCoy, SM., Campbell, KL., Lassemillante, AM., et al.[2022]

The study involving 15 patients with end-stage liver disease showed that an immune-enhancing diet (Impact) was safe and well-tolerated both before and after liver transplantation, with no safety concerns reported.

Patients who received the Impact diet experienced a significant increase in total body protein before surgery and had better recovery post-transplant, with fewer infectious complications compared to those who received standard nutritional intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre- and postoperative immunonutrition in patients undergoing liver transplantation: a pilot study of safety and efficacy. Plank, LD., McCall, JL., Gane, EJ., et al.[2006]

The Mediterranean diet (MedDiet) significantly reduced triglyceride and total cholesterol levels, as well as body weight and insulin resistance (HOMA-IR), in patients with non-alcoholic fatty liver disease (NAFLD) based on a meta-analysis of five randomized controlled trials.

While the MedDiet showed benefits for certain cardiovascular risk factors, it did not lead to significant improvements in liver enzymes or blood pressure compared to a control diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Mediterranean diet on cardiovascular risk factors in non-alcoholic fatty liver disease patients: A systematic review and meta-analysis. Asbaghi, O., Choghakhori, R., Ashtary-Larky, D., et al.[2021]

The Mediterranean Diet (MedDiet) has been linked to numerous health benefits, particularly in reducing the risk of cardiovascular diseases, metabolic disorders, and cancer, as evidenced by an increase in clinical trials over the last decade.

The diet's positive effects are largely attributed to its anti-inflammatory and antioxidant properties, with strict adherence and specific components like olive oil playing crucial roles in managing obesity and waist circumference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mediterranean Diet: An Update of the Clinical Trials. Finicelli, M., Di Salle, A., Galderisi, U., et al.[2022]

In a study of 60 adults with non-alcoholic fatty liver disease (NAFLD), those who adhered more closely to the Mediterranean diet showed significant reductions in intrahepatic fat content, liver damage markers, and improvements in cardiorespiratory fitness after a 6-month intervention.

Higher adherence to the Mediterranean diet was associated with increased antioxidant enzyme activity and decreased levels of inflammation biomarkers, indicating that this dietary approach may effectively reduce oxidative stress and inflammation in NAFLD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased Adherence to the Mediterranean Diet after Lifestyle Intervention Improves Oxidative and Inflammatory Status in Patients with Non-Alcoholic Fatty Liver Disease. Monserrat-Mesquida, M., Quetglas-Llabrés, M., Bouzas, C., et al.[2022]

In a randomized clinical trial involving 151 liver transplant patients, those who participated in a combined exercise and dietary counseling program showed significant improvements in exercise capacity (VO2peak) and self-reported general health compared to those receiving usual care.

Adherence to the intervention was relatively low at 37%, but those who adhered to the program experienced better outcomes in exercise capacity and body composition, highlighting the importance of early and consistent lifestyle modifications after liver transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of exercise and dietary counseling after liver transplantation. Krasnoff, JB., Vintro, AQ., Ascher, NL., et al.[2023]

In a study of 511 liver transplant recipients, those from central Italy showed significantly higher adherence to the Mediterranean diet compared to those from northern and southern Italy, indicating regional dietary differences post-transplant.

Factors such as better physical health and a longer time since transplant were associated with greater adherence to the Mediterranean diet, suggesting that ongoing education about diet and lifestyle is crucial for improving health outcomes in liver transplant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Mediterranean diet in liver transplant recipients: a cross-sectional multicenter study. Gitto, S., Golfieri, L., Sofi, F., et al.[2023]

Citations

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Mediterranean Diet Post-liver Transplantation A modified Mediterranean diet after liver transplantation results in relative improvement in 10-year ASCVD risk in patients who adhere to the ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20529095

Mediterranean Diet Post-liver Transplantation The purposes of this study are to prospectively evaluate the effects of a structured, modified Mediterranean diet on post-liver transplant weight gain and ...

3. withpower.com withpower.com/trial/phase-2021-54103?condition=liver+transplant&overallStatus=Recruiting&hasNoPlacebo=false

Dietary Intervention for Post-Liver Transplant Health The Mediterranean Diet is unique for post-liver transplant health because it focuses on a balanced intake of fruits, vegetables, whole grains, and healthy fats, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10255417/

Nutritional Intake after Liver Transplant: Systematic Review ... Clinical guidelines recommend high energy and protein intakes to aid recovery after a liver transplant (LT) and to avoid foods that may cause ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37162468/

Adherence to Mediterranean diet in liver transplant recipients Patients from central Italy showed a significantly higher consumption of fruit, vegetables, legumes, cereals, olive oil, fish and a ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04672863/mediterranean-diet-post-liver-transplantation

Mediterranean Diet Post-liver Transplantation A modified Mediterranean diet after liver transplantation decreases the risk of development of NAFLD/NASH/NASH fibrosis in patients who adhere ...

7. hpbonline.org hpbonline.org/article/S1365-182X(19)31420-0/pdf

Mediterranean Diet Post-Liver Transplantation - HPB Results: The patient survival was 100% at one and three years, and 85.7% at five years after LT. One-, three- and five-year graft survivals were 100.0 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02174783?cond=%22Abdominal%20Obesity-Metabolic%20Syndrome%22&intr=%22Liver%20Extracts%22&viewType=Table&rank=6

Mediterranean Diet and Protein-Sparing Modified ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9992532/

Relationship between the Mediterranean diet and risk of ... Our results showed that adherence to the MedDiet significantly reduces the risk of hepatic fibrosis in individuals with NAFLD. Despite differences in ...