Modification of Diet in Renal Transplantation (MDRT)

NCT03612778 | Unknown

• 1 other identifier: MDRT
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplant; Complications

Keywords

nutrition; dyslipidemia; insulin resistance; inflammation

Outcome Measures

Primary Outcomes (1)

• Serum low density lipoprotein (LDL)-cholesterol

  Serum LDL-cholesterol concentration

  6 weeks and 3 months

Secondary Outcomes (20)

• Apolipoprotein B

  6 weeks and 3 months

• Reduction in insulin resistance

  6 weeks and 3 months

• Serum cholesterol

  6 weeks and 3 months

• Oxidized Low Density Lipoprotein (LDL)-cholesterol

  6 weeks and 3 months

• Inflammatory marker high sensitive C-Reactive Protein (hs-CRP)

  6 weeks and 3 months

Study Arms (2)

Plant-based diet

EXPERIMENTAL

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

Mediterranean diet

ACTIVE COMPARATOR

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

Interventions

Plant-based diet BEHAVIORAL

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.

Plant-based diet

Mediterranean diet BEHAVIORAL

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.

Mediterranean diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• recipient of kidney transplant \> 12 weeks after transplantation and evaluated as clinically stable
• estimated glomerular filtration rate (GFR) \> 15 ml/min/1.73
• ability to participate in a lifestyle modification study.

You may not qualify if:

• nephrotic syndrome
• pregnancy
• treatment with vitamin K antagonists

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre

Ljubljana, Slovenia

RECRUITING

Related Publications (18)

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  PMID: 21663949 BACKGROUND

• Barnard ND, Scialli AR, Turner-McGrievy G, Lanou AJ, Glass J. The effects of a low-fat, plant-based dietary intervention on body weight, metabolism, and insulin sensitivity. Am J Med. 2005 Sep;118(9):991-7. doi: 10.1016/j.amjmed.2005.03.039.

  PMID: 16164885 BACKGROUND

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• Claesson K, Mayer AD, Squifflet JP, Grabensee B, Eigler FW, Behrend M, Vanrenterghem Y, van Hooff J, Morales JM, Johnson RW, Buchholz B, Land W, Forsythe JL, Neumayer HH, Ericzon BG, Muhlbacher F. Lipoprotein patterns in renal transplant patients: a comparison between FK 506 and cyclosporine A patients. Transplant Proc. 1998 Jun;30(4):1292-4. doi: 10.1016/s0041-1345(98)00246-2. No abstract available.

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• Heemann U, Abramowicz D, Spasovski G, Vanholder R; European Renal Best Practice Work Group on Kidney Transplantation. Endorsement of the Kidney Disease Improving Global Outcomes (KDIGO) guidelines on kidney transplantation: a European Renal Best Practice (ERBP) position statement. Nephrol Dial Transplant. 2011 Jul;26(7):2099-106. doi: 10.1093/ndt/gfr169. Epub 2011 May 9.

  PMID: 21555392 BACKGROUND

• Holdaas H, Fellstrom B, Cole E, Nyberg G, Olsson AG, Pedersen TR, Madsen S, Gronhagen-Riska C, Neumayer HH, Maes B, Ambuhl P, Hartmann A, Staffler B, Jardine AG; Assessment of LEscol in Renal Transplantation (ALERT) Study Investigators. Long-term cardiac outcomes in renal transplant recipients receiving fluvastatin: the ALERT extension study. Am J Transplant. 2005 Dec;5(12):2929-36. doi: 10.1111/j.1600-6143.2005.01105.x.

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• Israni AK, Snyder JJ, Skeans MA, Peng Y, Maclean JR, Weinhandl ED, Kasiske BL; PORT Investigators. Predicting coronary heart disease after kidney transplantation: Patient Outcomes in Renal Transplantation (PORT) Study. Am J Transplant. 2010 Feb;10(2):338-53. doi: 10.1111/j.1600-6143.2009.02949.x.

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• Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009 Nov;9 Suppl 3:S1-155. doi: 10.1111/j.1600-6143.2009.02834.x.

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• Wanner C, Tonelli M; Kidney Disease: Improving Global Outcomes Lipid Guideline Development Work Group Members. KDIGO Clinical Practice Guideline for Lipid Management in CKD: summary of recommendation statements and clinical approach to the patient. Kidney Int. 2014 Jun;85(6):1303-9. doi: 10.1038/ki.2014.31. Epub 2014 Feb 19.

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• Authors/Task Force Members:; Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WM, Vlachopoulos C, Wood DA, Zamorano JL. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias: The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) Developed with the special contribution of the European Assocciation for Cardiovascular Prevention & Rehabilitation (EACPR). Atherosclerosis. 2016 Oct;253:281-344. doi: 10.1016/j.atherosclerosis.2016.08.018. Epub 2016 Sep 1. No abstract available.

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MeSH Terms

Conditions

Dyslipidemias; Insulin Resistance; Inflammation

Interventions

Diet, Plant-Based; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jernej Pajek, MD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jernej Pajek, MD

CONTACT

0038615222941; jernej.pajek@mf-uni-lj.si

Ana Dovc, MD

CONTACT

0038615222941; ana.dovc@kclj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Jernej Pajek, MD, PhD

Model Details: Randomized controlled trial with two parallel groups.

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: August 2, 2018
• Study Start: November 15, 2018
• Primary Completion: March 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 22, 2018

Record last verified: 2018-10

Locations

SL (1)