Modification of Diet in Renal Transplantation (MDRT) (MDRT)

October 18, 2018 updated by: Jernej Pajek, University Medical Centre Ljubljana

Nutritional Intervention for Management of Cardiovascular Risk Factors in Kidney Transplant Patients

Abnormalities in lipid metabolism are present in 50-80% of patients with a kidney transplant and together with concurrent comorbidities and other associated cardiovascular risk factors put kidney transplant recipients at a high-risk for cardiovascular disease. First line lipid-lowering therapy in this population is pharmacological with 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), however there is a paucity of data on the efficacy of therapeutic lifestyle modification for cardiovascular risk management in kidney transplant recipients. The aim of the present study is to assess efficacy, safety and feasibility of a nutritional intervention for lowering cardiovascular risk factors in kidney transplant recipients. Investigators will conduct a randomized controlled trial on the effects of a low-fat, unrefined, plant-based diet compared to the currently recommended diet according to nutrition guidelines and based on the Mediterranean diet pattern to lower the primary end-point LDL-cholesterol and other secondary end-points validated as risk factors for cardiovascular events. Length of the intervention will be 6 weeks, with a late follow-up after additional 3 months. Stabile kidney transplant recipients with LDL-cholesterol >2.6 mmol/l and/or receiving lipid lowering treatment will be randomized in a 1:1 ratio to either interventional low-fat, unrefined, plant-based diet or to a control diet based on the Mediterranean dietary pattern. Both diets will be prescribed in the form of a weekly menu, both will be allowed to be eaten ad libitum (without prespecified calorie restriction) and in both groups study participants will be supported by tutor classes and counseling to maximise their adherence to prescribed dietary pattern.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND. Abnormalities in lipid metabolism are present in 50-80% of patients with a kidney transplant, as a consequence of both the primary cause of end-stage renal disease, its complications and immunosuppressive therapy. Concurrent comorbidities and cardiovascular risk factors put kidney transplant recipients at high-risk for cardiovascular disease, therefore the target LDL-cholesterol was set to below 2.6 mmol/l (< 100 mg/dl) by the guidelines. First line lipid-lowering therapy in this population is pharmacological, namely with HMG-CoA reductase inhibitors (statins), which have potential interactions with immunosuppressive drugs and increased risk of adverse effects. There is a paucity of data on the efficacy of therapeutic lifestyle modification for cardiovascular risk management in the kidney transplant recipient. Studies in the general population showed a significant effect of mostly plant-based nutrition on lowering lipid levels, achieving approximately 10-15% reduction in both total and LDL-cholesterol, while the effect on cardiovascular protection of such nutritional intervention remains hypothetical. The aim of the present study is to confirm efficacy, safety and feasibility of nutritional intervention for lowering cardiovascular risk factors in kidney transplant recipients. METHODS. Investigators will conduct a randomized controlled trial on the effects of a low-fat, unrefined, plant-based diet compared to the currently recommended diet based on the Mediterranean dietary pattern and complying with current nutrition guidelines for general population to lower LDL-cholesterol. Duration of dietary intervention will be 6 weeks with further extension of intervention and assessment of end-points after additional 3 months. Final follow-up is scheduled after 12 months regardless of continuation of the intervention as decided by subjects themselves. Subjects in the experimental group will receive a meal plan based on low-fat, unrefined, plant based foods with the goal macronutrient intake of approximately 15% protein, <15 % fats and 70-75% of carbohydrates, and will additionally receive polyunsaturated fatty acid (PUFA n-3) supplement (daily dose 840 mg) to ensure daily recommended intake. Subjects in the control group will receive a meal plan in accordance with recommendations by the Task Force for the Management of Dyslipidaemias of the European Society of Cardiology and European Atherosclerosis Society incorporating foods according to the Mediterranean dietary pattern including the usage of (but not limited to) olive oil, fatty-fish and low-fat dairy products. To promote adherence to the meal plan, subjects will receive dietary counselling and will be invited to attend weekly peer-group meetings together with a next of kin. Both diets will be allowed to be eaten at libitum and no calorie counts will be made. A random 24-hour recall, announced prospective 3-day food diary analysis and analysis of a 24-hour urine collection to determine adherence to the prescribed meal plan will be performed. To ensure safety, periodically monitoring of basic serum electrolyte concentrations, body weight and composition, and adjustment of antihypertensive and antihyperglycemic medications will be allowed. No change of lipid lowering agents will be allowed for the first 6-week study period. Feasibility of the intervention will be assessed by adherence monitoring as described above and with the Kidney Disease Quality of Life Short Form questionnaire. Analysis of covariance with baseline parameter value used as a covariate will be used for primary statistical analysis. Based on expected effect of nutritional intervention on lowering LDL-cholesterol by 0.6 mmol/l (23 mg/dl) in the study population by the end of intervention period, standard deviation of LDL-cholesterol of 0.6 mmol/l (23 mg/dl) in the study population with the expected drop-out rate of 15 %, the required sample size of 43 participants in each group to achieve a statistical significance p < 0.05 and statistical power of 80% is defined.

Study Type

Interventional

Enrollment (Anticipated)

86

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
        • Recruiting
        • University Medical Centre
        • Contact:
          • Jernej Pajek, PhD

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • recipient of kidney transplant > 12 weeks after transplantation and evaluated as clinically stable
  • age 18 years or more at inclusion
  • estimated glomerular filtration rate (GFR) > 15 ml/min/1.73
  • diagnosed dyslipidemia (LDL-cholesterol > 2.6 mmol/l (> 100 mg/dl) at inclusion or receiving lipid-lowering therapy)
  • ability to participate in a lifestyle modification study.

Exclusion Criteria:

  • acute illness, infection or surgical intervention requiring hospitalization in 6 weeks before inclusion, except procedures relating to arteriovenous fistula
  • treatment of acute rejection or citomegalovirus infection in 6 weeks before inclusion
  • chronic illness, associated with or increasing the risk of cachexia (including congestive heart failure New York Heart Association III or IV, AIDS, advanced chronic obstructive pulmonary disease, metastatic neoplastic disease or locally active neoplastic disease, chemotherapy treatment in 6 weeks before inclusion)
  • clinically evident malnutrition (BMI < 18,5, reduction of body weight > 5% in 3 months before inclusion, reduction of dietary intake > 25 % from normal in 2 weeks before inclusion, serum albumin < 30 g/l (< 3 g/dl))
  • nephrotic syndrome
  • pregnancy
  • treatment with vitamin K antagonists
  • change in lipid-lowering therapy in 3 weeks before inclusion

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plant-based diet
Participants will receive a meal plan based on unrefined plant-based foods with the following macronutrient composition: approximately 15% of calories from vegetable protein, <15% from fat, and 70-75% from carbohydrates. Additionally, to ensure adequate intake of n-3 polyunsaturated fatty acids, they will receive a supplement in the form of one 840 mg n-3 acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) daily. Nutritional intervention includes dietary counselling and weekly peer-group meetings together with a next of kin.
Behavioral: Plant-based diet
Prescription of a meal plan based on unrefined plant-based foods supported by peer group meetings and dietary counselling. Change from the standard western-type nutritional pattern to a low-fat, unrefined, plant-based nutritional pattern.
Active Comparator: Mediterranean diet
Participants will receive a meal plan, based on the recommendations by the Task Force for the Management of Dyslipidaemias of the European Society of Cardiology and European Atherosclerosis Society, based on Mediterranean diet pattern with the following macronutrient composition: approximately 15% of calories from animal and vegetable protein, up to 30% of calories from fat, 50-65% from carbohydrates. Nutritional intervention includes dietary counselling and weekly peer-group meetings together with a next of kin.
Behavioral: Mediterranean diet
Prescription of a meal plan based on Mediterranean diet pattern supported by peer group meetings and dietary counselling. Change from the standard western-type nutritional pattern to a Mediterranean nutritional pattern.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum low density lipoprotein (LDL)-cholesterol
Time Frame: 6 weeks and 3 months
Serum LDL-cholesterol concentration
6 weeks and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apolipoprotein B
Time Frame: 6 weeks and 3 months
Apolipoprotein B serum concentration
6 weeks and 3 months
Reduction in insulin resistance
Time Frame: 6 weeks and 3 months
Change in insulin resistance, measured by Homeostatic Model Assessment (HOMA-IR)
6 weeks and 3 months
Serum cholesterol
Time Frame: 6 weeks and 3 months
Serum total cholesterol concentration
6 weeks and 3 months
Oxidized Low Density Lipoprotein (LDL)-cholesterol
Time Frame: 6 weeks and 3 months
Serum concentration of oxidized LDL-cholesterol
6 weeks and 3 months
Inflammatory marker high sensitive C-Reactive Protein (hs-CRP)
Time Frame: 6 weeks and 3 months
Serum concentration of inflammatory marker high sensitive C-reactive Protein
6 weeks and 3 months
Total fat tissue mass
Time Frame: 6 weeks and 3 months
Total body fat mass measured with bioimpedance analysis
6 weeks and 3 months
Lean tissue mass
Time Frame: 6 weeks and 3 months
Lean tissue mass measured by bioimpedance analysis
6 weeks and 3 months
Blood pressure
Time Frame: 6 weeks and 3 months
Office measured blood pressure
6 weeks and 3 months
Proteinuria
Time Frame: 6 weeks and 3 months
Spot urinary protein to creatinine-ratio of the second morning urine
6 weeks and 3 months
Serum potassium
Time Frame: 6 weeks and 3 months
Serum potassium concentration (safety outcome)
6 weeks and 3 months
Serum phosphate
Time Frame: 6 weeks and 3 months
Serum phosphate concentration
6 weeks and 3 months
Serum bicarbonate
Time Frame: 6 weeks and 3 months
Serum concentration of bicarbonate (safety outcome)
6 weeks and 3 months
Serum uric acid
Time Frame: 6 weeks and 3 months
Serum uric acid concentration (safety outcome)
6 weeks and 3 months
Micronutrient status of Selenium (safety outcome)
Time Frame: 6 weeks and 3 months
Plasma Selenium concentration
6 weeks and 3 months
n-3 Polyunsaturated Fatty Acid (PUFA) status
Time Frame: 6 weeks and 3 months
n-3 PUFA content of erythrocyte lipid fraction
6 weeks and 3 months
Urinary C-X-C motif chemokine 10 (CXCL10)
Time Frame: 6 weeks and 3 months
Urinary levels of C-X-C motif chemokine 10 (CXCL10) as an indicator of tubulointerstital and microvascular inflammation
6 weeks and 3 months
Gut produced uremic toxin p-cresyl sulphate
Time Frame: 6 weeks and 3 months
Serum level of total and free p-cresyl sulphate
6 weeks and 3 months
Urinary iodine concentration
Time Frame: 6 weeks and 3 months
Urinary level of iodine concentration in ug/L
6 weeks and 3 months
Plasma Zinc concentration (safety outcome)
Time Frame: 6 weeks and 3 months
Plasma zinc concentration
6 weeks and 3 months
Serum calcium concentration (safety outcome)
Time Frame: 6 weeks and 3 months
Serum concentration of total calcium in mmol/l
6 weeks and 3 months

Collaborators and Investigators

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

Sponsor

University Medical Centre Ljubljana

Investigators

  • Principal Investigator: Jernej Pajek, MD, 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

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 (Anticipated)

November 15, 2018

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

June 28, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

October 22, 2018

Last Update Submitted That Met QC Criteria

October 18, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MDRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Kidney Transplant; Complications

Clinical Trials on Plant-based diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe