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Dietary Intervention for Post-Liver Transplant Health

N/A

Recruiting

Led By Kymberly Watt, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acceptable graft function (total bilirubin level < 5 mg/dL and doppler ultrasound with patent hepatic artery, hepatic veins and portal veins)

Ascites-adjusted BMI ≥ 25 kg/m2

Must not have

Associated medical conditions incompatible with safe participation in a nutritional intervention study, including digestive diseases with fat intolerance, neurological, psychiatric or endocrine disorders

Multi-organ transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of a Mediterranean diet on weight gain, heart health, and fatty liver disease after a liver transplant.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves dietary changes rather than medication, side effects may include difficulty adjusting to new eating habits or food preferences. However, no specific medical side effects are expected from adhering to a Mediterranean diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have received transplants for more than one organ.

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My liver cancer does not meet certain surgical criteria.

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I have had weight loss surgery in the past.

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My diabetes is not under control (HbA1c > 10%).

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I have untreated blood vessel or bile duct issues after a transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

weight gain

Secondary study objectives

fat mass changes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Behavioral: Structured Modified Mediterranean DietExperimental Treatment1 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 GroupActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary Intervention

2014

Completed Phase 2

~2550

0 / 9Eligibility criteria met