Recruiting

Mediterranean Diet

Sponsor:

Mayo Clinic

Code:

NCT04672863

Conditions

Liver Transplantation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dietary Intervention

Study Details

Brief summary:

The purpose of this study is to study the effects of a structured Mediterranean dietary program on prevention of weight gain, promotion of heart health and prevention of fatty liver disease after liver transplantation.

Conditions

Liver Transplantation

Study ID

NCT04672863

Start date

Jan 19, 2021

Status verified date

Jan, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Adult patients ≥ 18 years of age undergoing primary liver transplant
  • Ascites-adjusted BMI ≥ 25 kg/m2
  • Acceptable graft function (total bilirubin level < 5 mg/dL and doppler ultrasound with patent hepatic artery, hepatic veins and portal veins)

Exclusion Criteria

  • Hepatocellular carcinoma (HCC) that did not fulfill Milan criteria as per explant histology
  • Untreated post-transplant vascular complications or biliary strictures
  • Multi-organ transplantation
  • Urine protein excretion ≥2.0 g/day
  • Uncontrolled diabetes mellitus (HbA1c > 10%)
  • Associated medical conditions incompatible with safe participation in a nutritional intervention study, including digestive diseases with fat intolerance, neurological, psychiatric or endocrine disorders
  • Active eating disorder (e.g. bulimia nervosa, anorexia nervosa)
  • History of bariatric surgery
  • Pregnancy or planning on pregnancy in the next year

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Standard of Care Group

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.

experimental: Behavioral: Structured Modified Mediterranean Diet

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.

Interventions

Dietary Intervention

Modified Mediterranean diet approved by the Nutrition Team at the Transplant Center and it emphasizes consumption of fruits, vegetables, whole grains, beans and nuts, in addition to low salt (2-2.4g/day), moderate amounts of lean protein (primarily fish and poultry) in addition to low to moderate quantities of monounsaturated fats. The modifications to the traditional Mediterranean diet are: no alcohol consumption and fewer added fats. In addition, close scheduled followup on diet and progress with study team.

Primary outcome measure

  • weight gain [ Time Frame: 4 months ]
  • weight gain [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Mohammad Qasim Khan, M.B.B.S.

507-284-3917khan.mohammadqasim@mayo.edu

Kymberly Watt, MD

507-266-1586watt.kymberly@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Kymberly Watt, MD

5072661586watt.kymberly@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-07.