MedDiet in Kidney Transplant Recipients (MedDiet_KT)

July 28, 2026 updated by: Tanja Belčič Mikič, University Medical Centre Ljubljana

6-Week Mediterranean Diet Intervention on Dietary Adherence, Body Composition, and Physical Function in Kidney Transplant Recipients: A Pilot Randomized Controlled Trial

In recent years, increasing attention has been directed toward the role of diet and lifestyle factors in influencing graft function and patient survival after kidney transplantation (KT). Among the dietary patterns investigated, the Mediterranean diet (MedDiet) is among most studied diets in KT recipients. Data from observational studies show that greater adherence to the MedDiet is beneficial in kidney transplant recipients and is associated with improved lipid profile, lower oxidative stress, less frequent new-onset diabetes mellitus after transplantation, metabolic syndrome, better kidney function, and mortality. Unfortunately, adherence to MedDiet in kidney transplant recipients is low, and ranges between 25 % and 44.7%. Data from a Dutch cross-sectional study showed that higher levels of food literacy are associated with better adherence to MedDiet. Nevertheless, evidence from randomized dietary interventions aimed at improving MedDiet adherence in this population remains limited. Therefore, the aim of our pilot randomized controlled trial was to evaluate whether a six-week MedDiet intervention could improve adherence to the Mediterranean dietary pattern, assessed using the Mediterranean Diet Adherence Screener (MEDAS), and to explore the effects of MedDiet on body composition and physical function. We conducted an interventional, randomized study at the Kidney Transplantation Centre, Department of Nephrology, University Medical Centre Ljubljana. The intervention duration was six weeks and was performed by a Master's student in nutrition. We included kidney transplant recipients undergoing regular follow-up at the Kidney Transplantation Centre. Patients were invited to participate verbally via telephone contact one week prior to their scheduled physician appointment. Participation was voluntary and confirmed by a signed informed consent. The following exclusion criteria were applied: body mass index (BMI) > 25 kg/m², age > 45 years, female sex, serum creatinine > 250 µmol/L, a MEDAS score ≥ 10 points, and systolic blood pressure > 160 mmHg. Patients were randomized to the intervention and control group.

The primary study outcome was the MEDAS score. Secondary outcomes were lean tissue index (LTI; kg/m²), fat tissue index (FTI; kg/m²), handgrip strength (kg), and chair-stand performance (number of repetitions).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • UMC Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years old
  • male
  • kidney transplant recipient

Exclusion Criteria:

  • body mass index (BMI) > 25 kg/m²
  • age > 45 years
  • female sex
  • serum creatinine > 250 µmol/L,
  • a MEDAS score ≥ 10 points, and systolic blood pressure > 160 mmHg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention (MedDiet) group
Med Diet group
Behavioral: MedDiet
intervention with Mediterranean Diet
No Intervention: Control arm
No specific dietary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mediterranean Diet Adherence Screener (MEDAS)
Time Frame: 6 weeks
adherence to the Mediterranean Diet was measured using the MEDAS before and after the 6 week intervention
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lean tissue index (LTI; kg/m²)
Time Frame: 6 weeks
6 weeks
fat tissue index (FTI; kg/m²)
Time Frame: 6 weeks
6 weeks
handgrip strength (kg)
Time Frame: 6 weeks
6 weeks
chair-stand test
Time Frame: 6 weeks
30-second chair-stand performance (number of repetitions)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

July 28, 2026

First Submitted That Met QC Criteria

July 28, 2026

First Posted (Actual)

August 3, 2026

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 28, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120-375/2023/3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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