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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
weight gain
Secondary outcome measures
fat mass changes

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

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,245 Previous Clinical Trials
3,783,361 Total Patients Enrolled
Kymberly Watt, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
156 Total Patients Enrolled

Media Library

Mediterranean Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04672863 — N/A
Liver Transplant Research Study Groups: Standard of Care Group, Behavioral: Structured Modified Mediterranean Diet
Liver Transplant Clinical Trial 2023: Mediterranean Diet Highlights & Side Effects. Trial Name: NCT04672863 — N/A
Mediterranean Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04672863 — N/A
~9 spots leftby Dec 2024
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