Dietary Intervention Trial Targeting Metabolic Syndrome After Kidney Transplantation (DIETTX)
Primary Purpose
Kidney Transplant; Complications
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
high-protein, carbohydrate-reduced diet
Dutch Nutritional Guidelines
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Transplant; Complications focused on measuring kidney transplantation, metabolic syndrome, high-protein diet, dietary intervention
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
high-protein, carbohydrate-reduced diet
Dutch Nutritional Guidelines
Arm Description
Outcomes
Primary Outcome Measures
Systolic blood pressure
Change in systolic blood pressure (in mmHg)
Secondary Outcome Measures
Cardio-metabolic risk factors (lipids)
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)
Change in diastolic blood pressure (in mmHg)
Cardio-metabolic risk factors (waist circumference)
change in waist circumference (WC) in cm
Cardio-metabolic risk factors (insulin resistance)
change in insulin resistance measuring by the homeostatic model assessment of insulin resistance (HOMA-IR index, fasting glucose, insulin)
Body composition
change in fat and muscle mass measured by multi-frequency bio-electrical impedance analysis (BIA) BMI, weight
Anthropometric measures
Change in weight in kilograms
Anthropometric measures II
Change in Body Mass Index (BMI) in kilograms per square meter
Body composition II
change in fat and muscle mass measured by multi-frequency bio-electrical impedance analysis (BIA)
Quality of life (QoL)
change in QoL, 12-item short form health survey (SF-12)
Fatigue
change in fatigue (measured by Dutch Checklist Individual Strength (CIS-20) questionnaire)
Physical functioning
change in Hand Grip Strength (HSG)
Physical functioning II
change in the five time sit to stand (FTSTS) test
Nutritional intake
change in nutritional intake measured by a 3-day food diary
Nutritional intake II
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)
Full Information
NCT ID
NCT04698408
First Posted
December 23, 2020
Last Updated
January 5, 2021
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT04698408
Brief Title
Dietary Intervention Trial Targeting Metabolic Syndrome After Kidney Transplantation
Acronym
DIETTX
Official Title
Dietary Intervention Trial Targeting Metabolic Syndrome After Renal Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant; Complications
Keywords
kidney transplantation, metabolic syndrome, high-protein diet, dietary intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high-protein, carbohydrate-reduced diet
Arm Type
Experimental
Arm Title
Dutch Nutritional Guidelines
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
high-protein, carbohydrate-reduced diet
Intervention Description
the high-protein, carbohydrate-reduced diet will consist of 1.2-1.4 g/kg/d protein, 26-20en% carbohydrates and +/- 50en% fatty acids, with mainly unsaturated fatty acids. This diet consist of mainly unprocessed, fresh nutrient-dense food-products. Ultra-processed foods and alcoholic beverages will be totally avoided. Salt consumption will not exceed 5-6 g/d. The diet is ad libitum and caloric restriction will not be applied. The diet will be followed for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Dutch Nutritional Guidelines
Intervention Description
the diet according to the Dutch Nutritional Guidelines will consist of a protein intake of 0.8-1.0 g/kg/d and 50-60en% carbohydrates, and +/-30en% fatty acids, with restriction of saturated fatty acids <10en%. This diet consist of mainly unprocessed, fresh nutrient-dense food-products. Ultra-processed foods and alcoholic beverages will be totally avoided. Salt consumption will not exceed 5-6 g/d. The diet is ad libitum and caloric restriction will not be applied. The diet will be followed for 6 weeks.
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
Change in systolic blood pressure (in mmHg)
Time Frame
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)
Secondary Outcome Measure Information:
Title
Cardio-metabolic risk factors (lipids)
Description
change in circulating triglyceride concentrations, low-density lipoprotein cholesterol (LDL-C) and HDL-C (in fasting serum levels) in mmol/L.
Time Frame
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)
Title
Cardio-metabolic risk factors (diastolic blood pressure)
Description
Change in diastolic blood pressure (in mmHg)
Time Frame
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)
Title
Cardio-metabolic risk factors (waist circumference)
Description
change in waist circumference (WC) in cm
Time Frame
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)
Title
Cardio-metabolic risk factors (insulin resistance)
Description
change in insulin resistance measuring by the homeostatic model assessment of insulin resistance (HOMA-IR index, fasting glucose, insulin)
Time Frame
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)
Title
Body composition
Description
change in fat and muscle mass measured by multi-frequency bio-electrical impedance analysis (BIA) BMI, weight
Time Frame
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)
Title
Anthropometric measures
Description
Change in weight in kilograms
Time Frame
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)
Title
Anthropometric measures II
Description
Change in Body Mass Index (BMI) in kilograms per square meter
Time Frame
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)
Title
Body composition II
Description
change in fat and muscle mass measured by multi-frequency bio-electrical impedance analysis (BIA)
Time Frame
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)
Title
Quality of life (QoL)
Description
change in QoL, 12-item short form health survey (SF-12)
Time Frame
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)
Title
Fatigue
Description
change in fatigue (measured by Dutch Checklist Individual Strength (CIS-20) questionnaire)
Time Frame
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)
Title
Physical functioning
Description
change in Hand Grip Strength (HSG)
Time Frame
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)
Title
Physical functioning II
Description
change in the five time sit to stand (FTSTS) test
Time Frame
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)
Title
Nutritional intake
Description
change in nutritional intake measured by a 3-day food diary
Time Frame
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)
Title
Nutritional intake II
Description
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)
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Dietary Intervention Trial Targeting Metabolic Syndrome After Kidney Transplantation
We'll reach out to this number within 24 hrs