MedDiet in Kidney Transplant Recipients

NCT07740928 | Completed

• 1 other identifier: 0120-375/2023/3
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diet Habit; Kidney Transplant Donor

Keywords

Mediterranean Diet; lifestyle; kidney transplantation

Outcome Measures

Primary Outcomes (1)

• Mediterranean Diet Adherence Screener (MEDAS)

  adherence to the Mediterranean Diet was measured using the MEDAS before and after the 6 week intervention

  6 weeks

Secondary Outcomes (4)

• lean tissue index (LTI; kg/m²)

  6 weeks

• fat tissue index (FTI; kg/m²)

  6 weeks

• handgrip strength (kg)

  6 weeks

• chair-stand test

  6 weeks

Study Arms (2)

Intervention (MedDiet) group

EXPERIMENTAL

Med Diet group

Behavioral: MedDiet

Control arm

NO INTERVENTION

No specific dietary intervention

Interventions

MedDiet BEHAVIORAL

intervention with Mediterranean Diet

Intervention (MedDiet) group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• male
• kidney transplant recipient

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (3)

• Billany RE, Bishop NC, Castle EM, Graham-Brown MPM, Greenwood SA, Lightfoot CJ, Wilkinson TJ. Physical activity interventions in adult kidney transplant recipients: an updated systematic review and meta-analysis of randomized controlled trials. Ren Fail. 2025 Dec;47(1):2480246. doi: 10.1080/0886022X.2025.2480246. Epub 2025 Mar 27.

  PMID: 40148080 BACKGROUND

• Ying T, Shi B, Kelly PJ, Pilmore H, Clayton PA, Chadban SJ. Death after Kidney Transplantation: An Analysis by Era and Time Post-Transplant. J Am Soc Nephrol. 2020 Dec;31(12):2887-2899. doi: 10.1681/ASN.2020050566. Epub 2020 Sep 9.

  PMID: 32908001 BACKGROUND

• Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D, Klarenbach S, Gill J. Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant. 2011 Oct;11(10):2093-109. doi: 10.1111/j.1600-6143.2011.03686.x. Epub 2011 Aug 30.

  PMID: 21883901 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

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: Nephrology Specialist

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start: May 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: January 1, 2024
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)