Dietary Intervention Trial Targeting Metabolic Syndrome After Kidney Transplantation
- Conditions
- Kidney Transplant; Complications
- Interventions
- Other: Dutch Nutritional GuidelinesOther: high-protein, carbohydrate-reduced diet
- Registration Number
- NCT04698408
- Lead Sponsor
- University Medical Center Groningen
- Brief Summary
Kidney transplant recipients (KTR) have a considerably lower life expectancy as compared with the general population, primarily due to a high prevalence of cardiovascular diseases. KTR often develop an unfavourable cardio-metabolic risk profile characterized by weight gain, metabolic syndrome and post-transplantation diabetes mellitus (PTDM). In general, nutrition plays a key role in both the prevention and treatment of these cardio-metabolic derangements.
However, in KTR most RCT's with a dietary intervention, failed to show significant improvement in cardio-metabolic health. This at least questions the efficacy of the diets of these intervention, which relied on general or diabetes guidelines, after kidney transplantation. KTR not only face a high cardio-metabolic risk, but also have a high risk for malnutrition and muscle mass depletion. More knowledge is required to determine the optimal diet and macronutrient composition for improvement of the cardio-metabolic risk factors in the context of the high malnutrition risk. In this regard, observational studies point towards the needs for a higher protein intake for better patient outcomes. Therefore, in this study, the investigators will examine if a high-protein, carbohydrate-reduced diet is more effective than a diet in line with the Dutch Dietary Guidelines for improvement of cardio-metabolic risk factors and for improvement of the body composition in KTR.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Age 18 years or older.
- Given informed consent.
- At least 6 months after kidney transplantation.
- Stable renal function with an estimated glomerular filtration rate (eGFR) > 30 mL/min.
- Raised systolic blood pressure (≥130 mmHg) and at least two more features of metabolic syndrome: central obesity (waist circumference ≥102 for men and ≥88cm for women), elevated triglycerides (≥ 1.7 mmol/L), reduced HDL-C (< 1.0 mmol/L for men and < 1.3 mmol/L for women) or on drug treatment for reduced HDL, elevated plasma glucose (≥ 5.6 mmol/L) or on drug treatment for elevated glucose9.
- Approval by nephrologist for participation in the study.
- Active medical illness, including rejection of the graft.
- Psychopathology or serious cognitive impairment.
- Necessity to follow specific dietary measures for health purposes that conflict with the study diets.
- Use of insulin or sulfonylurea (SU)-derivates.
- Language barrier.
- Pregnancy or lactating.
- Serum potassium > 5.0 mmol/L that requires dietary measures.
- Moderate or severe malnutrition (Patient-Generated Subjective Global Assessment (PG-SGA) stage B or C). In this case, patient will be referred to a renal dietician.
- Participation in other intervention trials.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Dutch Nutritional Guidelines Dutch Nutritional Guidelines - high-protein, carbohydrate-reduced diet high-protein, carbohydrate-reduced diet -
- Primary Outcome Measures
Name Time Method Systolic blood pressure before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks) Change in systolic blood pressure (in mmHg)
- Secondary Outcome Measures
Name Time Method Cardio-metabolic risk factors (lipids) before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks) change in circulating triglyceride concentrations, low-density lipoprotein cholesterol (LDL-C) and HDL-C (in fasting serum levels) in mmol/L.
Cardio-metabolic risk factors (diastolic blood pressure) before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks) Change in diastolic blood pressure (in mmHg)
Cardio-metabolic risk factors (waist circumference) before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks) change in waist circumference (WC) in cm
Cardio-metabolic risk factors (insulin resistance) before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks) change in insulin resistance measuring by the homeostatic model assessment of insulin resistance (HOMA-IR index, fasting glucose, insulin)
Body composition before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks) change in fat and muscle mass measured by multi-frequency bio-electrical impedance analysis (BIA) BMI, weight
Anthropometric measures before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks) Change in weight in kilograms
Anthropometric measures II before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks) Change in Body Mass Index (BMI) in kilograms per square meter
Body composition II before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks) change in fat and muscle mass measured by multi-frequency bio-electrical impedance analysis (BIA)
Quality of life (QoL) before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks) change in QoL, 12-item short form health survey (SF-12)
Fatigue before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks) change in fatigue (measured by Dutch Checklist Individual Strength (CIS-20) questionnaire)
Physical functioning before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks) change in Hand Grip Strength (HSG)
Physical functioning II before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks) change in the five time sit to stand (FTSTS) test
Nutritional intake before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks) change in nutritional intake measured by a 3-day food diary
Nutritional intake II before and after experimental diet (high-protein, carbohydrate-reduced diet - 6 weeks) / before and after active comparator (Dutch Nutritional Guidelines - 6 weeks) / wash-out period in between (6 weeks) change in nutritional intake measured by nutritional intake biomarkers from 24-hour urine measurements (sodium, potassium, and urea excretion for calculating the protein intake by use of the Maroni equation)