NCT04672863

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jan 2021Nov 2027

First Submitted

Initial submission to the registry

December 7, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 19, 2021

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

6.1 years

First QC Date

December 7, 2020

Last Update Submit

January 5, 2026

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (2)

  • weight gain

    weight in kilograms

    4 months

  • weight gain

    weight in kilograms

    12 months

Secondary Outcomes (2)

  • fat mass changes

    4 months

  • fat mass changes

    12 months

Study Arms (2)

Standard of Care Group

NO 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.

Behavioral: Structured Modified Mediterranean Diet

EXPERIMENTAL

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.

Behavioral: Dietary Intervention

Interventions

Dietary InterventionBEHAVIORAL

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.

Behavioral: Structured Modified Mediterranean Diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Kymberly Watt, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

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

Kymberly Watt, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 7, 2020

First Posted

December 17, 2020

Study Start

January 19, 2021

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)