Kidney Transplant; ComplicationsMDRTNCT03612778
Modification of Diet in Renal Transplantation (MDRT)
A study testing Plant-based diet and Mediterranean diet in people with Kidney Transplant; Complications, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Transplant; Complications
- What is being tested?
- Plant-based diet and Mediterranean diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 Nov 2018to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre
Ljubljana
Jernej Pajek, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Transplant; Complications
- Being tested
- Plant-based diet, Mediterranean diet
- Keywords
- nutrition, dyslipidemia, insulin resistance, inflammation
- Medical subject headings
- Dyslipidemias, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based dietBehavioural
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.
Mediterranean dietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum low density lipoprotein (LDL)-cholesterol
Serum LDL-cholesterol concentration
Measured: 6 weeks and 3 months
Secondary outcomes (20)
Apolipoprotein B
Apolipoprotein B serum concentration
Measured: 6 weeks and 3 months
Reduction in insulin resistance
Change in insulin resistance, measured by Homeostatic Model Assessment (HOMA-IR)
Measured: 6 weeks and 3 months
Serum cholesterol
Serum total cholesterol concentration
Measured: 6 weeks and 3 months
Oxidized Low Density Lipoprotein (LDL)-cholesterol
Serum concentration of oxidized LDL-cholesterol
Measured: 6 weeks and 3 months
Inflammatory marker high sensitive C-Reactive Protein (hs-CRP)
Serum concentration of inflammatory marker high sensitive C-reactive Protein
Measured: 6 weeks and 3 months
Total fat tissue mass
Total body fat mass measured with bioimpedance analysis
Measured: 6 weeks and 3 months
Lean tissue mass
Lean tissue mass measured by bioimpedance analysis
Measured: 6 weeks and 3 months
Blood pressure
Office measured blood pressure
Measured: 6 weeks and 3 months
Proteinuria
Spot urinary protein to creatinine-ratio of the second morning urine
Measured: 6 weeks and 3 months
Serum potassium
Serum potassium concentration (safety outcome)
Measured: 6 weeks and 3 months
Serum phosphate
Serum phosphate concentration
Measured: 6 weeks and 3 months
Serum bicarbonate
Serum concentration of bicarbonate (safety outcome)
Measured: 6 weeks and 3 months
Serum uric acid
Serum uric acid concentration (safety outcome)
Measured: 6 weeks and 3 months
Micronutrient status of Selenium (safety outcome)
Plasma Selenium concentration
Measured: 6 weeks and 3 months
n-3 Polyunsaturated Fatty Acid (PUFA) status
n-3 PUFA content of erythrocyte lipid fraction
Measured: 6 weeks and 3 months
Urinary C-X-C motif chemokine 10 (CXCL10)
Urinary levels of C-X-C motif chemokine 10 (CXCL10) as an indicator of tubulointerstital and microvascular inflammation
Measured: 6 weeks and 3 months
Gut produced uremic toxin p-cresyl sulphate
Serum level of total and free p-cresyl sulphate
Measured: 6 weeks and 3 months
Urinary iodine concentration
Urinary level of iodine concentration in ug/L
Measured: 6 weeks and 3 months
Plasma Zinc concentration (safety outcome)
Plasma zinc concentration
Measured: 6 weeks and 3 months
Serum calcium concentration (safety outcome)
Serum concentration of total calcium in mmol/l
Measured: 6 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start15 Nov 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two parallel groups.
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jernej Pajek, University Medical Centre Ljubljana
- Investigators
- Jernej Pajek, MD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612778
- Sponsor's protocol ID
- MDRT
- Acronym
- MDRT
- Status last verified
- Oct 2018
- First submitted
- 28 Jun 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baigent C, Landray MJ, Reith C, Emberson J, Wheeler DC, Tomson C, Wanner C, Krane V, Cass A, Craig J, Neal B, Jiang L, Hooi LS, Levin A, Agodoa L, Gaziano M, Kasiske B, Walker R, Massy ZA, Feldt-Rasmussen B, Krairittichai U, Ophascharoensuk V, Fellstrom B, Holdaas H, Tesar V, Wiecek A, Grobbee D, de Zeeuw D, Gronhagen-Riska C, Dasgupta T, Lewis D, Herrington W, Mafham M, Majoni W, Wallendszus K, Grimm R, Pedersen T, Tobert J, Armitage J, Baxter A, Bray C, Chen Y, Chen Z, Hill M, Knott C, Parish S, Simpson D, Sleight P, Young A, Collins R; SHARP Investigators. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011 Jun 25;377(9784):2181-92. doi: 10.1016/S0140-6736(11)60739-3. Epub 2011 Jun 12.
PubMed 21663949Barnard 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.
PubMed 16164885Van Breukelen GJ. ANCOVA versus change from baseline: more power in randomized studies, more bias in nonrandomized studies [corrected]. J Clin Epidemiol. 2006 Sep;59(9):920-5. doi: 10.1016/j.jclinepi.2006.02.007. Epub 2006 Jun 23.
PubMed 16895814Cartolano FC, Dias GD, de Freitas MCP, Figueiredo Neto AM, Damasceno NRT. Insulin Resistance Predicts Atherogenic Lipoprotein Profile in Nondiabetic Subjects. J Diabetes Res. 2017;2017:1018796. doi: 10.1155/2017/1018796. Epub 2017 Aug 22.
PubMed 28913361Claesson 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.
PubMed 9636524Ferdowsian HR, Barnard ND. Effects of plant-based diets on plasma lipids. Am J Cardiol. 2009 Oct 1;104(7):947-56. doi: 10.1016/j.amjcard.2009.05.032.
PubMed 19766762Gardner CD, Coulston A, Chatterjee L, Rigby A, Spiller G, Farquhar JW. The effect of a plant-based diet on plasma lipids in hypercholesterolemic adults: a randomized trial. Ann Intern Med. 2005 May 3;142(9):725-33. doi: 10.7326/0003-4819-142-9-200505030-00007.
PubMed 15867404Heemann 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.
PubMed 21555392Holdaas 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.
PubMed 16303007Israni 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.
PubMed 20415903Kidney 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.
PubMed 19845597Wanner 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.
PubMed 24552851Lopes TS, Luiz RR, Hoffman DJ, Ferriolli E, Pfrimer K, Moura AS, Sichieri R, Pereira RA. Misreport of energy intake assessed with food records and 24-h recalls compared with total energy expenditure estimated with DLW. Eur J Clin Nutr. 2016 Nov;70(11):1259-1264. doi: 10.1038/ejcn.2016.85. Epub 2016 Jun 8.
PubMed 27273069Ojo AO, Hanson JA, Wolfe RA, Leichtman AB, Agodoa LY, Port FK. Long-term survival in renal transplant recipients with graft function. Kidney Int. 2000 Jan;57(1):307-13. doi: 10.1046/j.1523-1755.2000.00816.x.
PubMed 10620213Palmer SC, Navaneethan SD, Craig JC, Perkovic V, Johnson DW, Nigwekar SU, Hegbrant J, Strippoli GF. HMG CoA reductase inhibitors (statins) for kidney transplant recipients. Cochrane Database Syst Rev. 2014 Jan 28;2014(1):CD005019. doi: 10.1002/14651858.CD005019.pub4.
PubMed 24470059
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention for Management of Cardiovascular Risk Factors in Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT03612778
- Acronym / sponsor ID
- MDRT / MDRT
- Conditions
- Kidney Transplant; Complications
- Keywords
- nutrition, dyslipidemia, insulin resistance, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 15 Nov 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Plant-based diet | Experimental | Behavioral: Plant-based dietParticipants 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. |
| Mediterranean diet | Active comparator | Behavioral: Mediterranean dietParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-based dietPrescription 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. | Behavioural | Plant-based diet |
| Mediterranean dietPrescription 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. | Behavioural | Mediterranean diet |
Primary outcome
Serum low density lipoprotein (LDL)-cholesterol
Time frame: 6 weeks and 3 months
Serum LDL-cholesterol concentration
20 secondary outcomes
Apolipoprotein B
Time frame: 6 weeks and 3 months
Reduction in insulin resistance
Time frame: 6 weeks and 3 months
Serum cholesterol
Time frame: 6 weeks and 3 months
Oxidized Low Density Lipoprotein (LDL)-cholesterol
Time frame: 6 weeks and 3 months
Inflammatory marker high sensitive C-Reactive Protein (hs-CRP)
Time frame: 6 weeks and 3 months
Total fat tissue mass
Time frame: 6 weeks and 3 months
Lean tissue mass
Time frame: 6 weeks and 3 months
Blood pressure
Time frame: 6 weeks and 3 months
Proteinuria
Time frame: 6 weeks and 3 months
Serum potassium
Time frame: 6 weeks and 3 months
Serum phosphate
Time frame: 6 weeks and 3 months
Serum bicarbonate
Time frame: 6 weeks and 3 months
Serum uric acid
Time frame: 6 weeks and 3 months
Micronutrient status of Selenium (safety outcome)
Time frame: 6 weeks and 3 months
n-3 Polyunsaturated Fatty Acid (PUFA) status
Time frame: 6 weeks and 3 months
Urinary C-X-C motif chemokine 10 (CXCL10)
Time frame: 6 weeks and 3 months
Gut produced uremic toxin p-cresyl sulphate
Time frame: 6 weeks and 3 months
Urinary iodine concentration
Time frame: 6 weeks and 3 months
Plasma Zinc concentration (safety outcome)
Time frame: 6 weeks and 3 months
Serum calcium concentration (safety outcome)
Time frame: 6 weeks and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Background: PubMed 21663949Baigent C, Landray MJ, Reith C, Emberson J, Wheeler DC, Tomson C, Wanner C, Krane V, Cass A, Craig J, Neal B, Jiang L, Hooi LS, Levin A, Agodoa L, Gaziano M, Kasiske B, Walker R, Massy ZA, Feldt-Rasmussen B, Krairittichai U, Ophascharoensuk V, Fellstrom B, Holdaas H, Tesar V, Wiecek A, Grobbee D, de Zeeuw D, Gronhagen-Riska C, Dasgupta T, Lewis D, Herrington W, Mafham M, Majoni W, Wallendszus K, Grimm R, Pedersen T, Tobert J, Armitage J, Baxter A, Bray C, Chen Y, Chen Z, Hill M, Knott C, Parish S, Simpson D, Sleight P, Young A, Collins R; SHARP Investigators. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011 Jun 25;377(9784):2181-92. doi: 10.1016/S0140-6736(11)60739-3. Epub 2011 Jun 12.
- Background: PubMed 16164885Barnard 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.
- Background: PubMed 16895814Van Breukelen GJ. ANCOVA versus change from baseline: more power in randomized studies, more bias in nonrandomized studies [corrected]. J Clin Epidemiol. 2006 Sep;59(9):920-5. doi: 10.1016/j.jclinepi.2006.02.007. Epub 2006 Jun 23.
- Background: PubMed 28913361Cartolano FC, Dias GD, de Freitas MCP, Figueiredo Neto AM, Damasceno NRT. Insulin Resistance Predicts Atherogenic Lipoprotein Profile in Nondiabetic Subjects. J Diabetes Res. 2017;2017:1018796. doi: 10.1155/2017/1018796. Epub 2017 Aug 22.
- Background: PubMed 9636524Claesson 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.
- Background: PubMed 19766762Ferdowsian HR, Barnard ND. Effects of plant-based diets on plasma lipids. Am J Cardiol. 2009 Oct 1;104(7):947-56. doi: 10.1016/j.amjcard.2009.05.032.
- Background: PubMed 15867404Gardner CD, Coulston A, Chatterjee L, Rigby A, Spiller G, Farquhar JW. The effect of a plant-based diet on plasma lipids in hypercholesterolemic adults: a randomized trial. Ann Intern Med. 2005 May 3;142(9):725-33. doi: 10.7326/0003-4819-142-9-200505030-00007.
- Background: PubMed 21555392Heemann 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.
- Background: PubMed 16303007Holdaas 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.
- Background: PubMed 20415903Israni 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.
- Background: PubMed 19845597Kidney 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.
- Background: PubMed 24552851Wanner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jernej Pajek, MD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based diet and Mediterranean diet in people with Kidney Transplant; Complications, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jernej Pajek, MD (0038615222941, jernej.pajek@mf-uni-lj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum low density lipoprotein (LDL)-cholesterol (time frame: 6 weeks and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03612778, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.