Dietary Interventions During Living Kidney Donations

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Cologne

About this trial

Monocentre, non-randomized, non-blinded, open-label interventional study to identification of relevant changes in molecular biology in proteome, phosphoproteome, lipidome, epigenome and transcriptome in pretransplant kidney biopsy samples in patients preconditioned by different dietary regimes (fasting mimicking diet vs. ketogenic diet vs. dietary restriction of sulfur containing amino acids vs. control patients)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients > 18 years of age

Planed living kidney transplantation (both donor and recipient are eligible)

Written informed consent

Disqualifiers

Vegetarian lifestyle

Body-Mass-Index (BMI) < 18.5 kg/m2

Calorie-reduced diet within the preceding four weeks

Underlying wasting syndrome

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fasting mimicking diet

    Dietary supplement

    Intermittent fasting with human fasting mimicking diet (Prolon®) will be performed for five days prior to living kidney donation in the donor. Prolon® a plant-based diet designed to attain fasting-like effects while provide providing both macro- and micronutrient. Each participant will obtain Prolon® diet during the first visit and the diet will stored at the participant's home at room temperature. Additionally, the participant will receive a food plan for the exact consumption of the diet. Regular phone with a predefined standardized questionnaire will be used to determine each participant's well-being, as well as his or her dietary adherence. Furthermore, the participants will be asked to write down each consumed food items they are consuming in diet-book, which is handed to them during the first visit. The participants are only allowed to consume water, coffee or tea without sugar simultaneously to the Prolon® diet.

  • Ketogenic diet

    Dietary supplement

    Isocaloric, ketogenic diet will be performed for seven days prior to living kidney donation in the donor. The ketogenic diet is based on the KetoCal 4:1 formula diet (Nutricia Milupa GmbH, Erlangen, Germany). Main fat sources are plant oils including palm oil and sunflower oils. The formula diet is provided as a powder that has to be mixed with water before use. To avoid a shortage in protein uptake supplement formula diets K-AM and Fortimel® (both Nutricia Milupa GmbH, Erlangen, Germany) will be used additionally. Salt uptake will be standardized employing either broths or salt tablets to not interfere with the steady-state salt and water homeostasis. A salt ingestion of 5g/day, which is common for western diets, is aimed at. The participants will receive a daily food plan by the dietetics at the University Hospital of Cologne to ensure standardized food consumption

  • Dietary restriction of sulfur containing amino acids

    Dietary supplement

    Isocaloric, dietary restriction of sulfur containing amino acids will be performed for seven days prior to living kidney donation in the donor. A dietary restriction of sulfur containing amino acids without restriction in protein uptake will be achieved by following the X Met X Cys Maxamaid formula diet (Nutricia Milupa GmbH, Erlangen, Germany). The formula diet is provided as a powder that has to be mixed with water before use. A minimum of methionine and cysteine uptake (10% of the common uptake per day) will be achieved by consuming individuial calculated amounts of the Fortimel® formula diet (Nutricia Milupa GmbH, Erlangen, Germany). To avoid a restriction in fat and energy uptake additionally the Calogen and Duocal formula diets (both Nutricia Milupa GmbH, Erlangen, Germany) will be used. A salt ingestion of 5g/day, which is common for western diets, is aimed at. The participants will receive a daily food plan to ensure standardized food consumption.

  • Control Group ( healthy, low-fat, moderate protein and high carbohydrate diet)

    Dietary supplement

    Participants in the control group will be instructed to adhere to a healthy, low-fat, moderate protein and high carbohydrate diet as described in current nutritional recommendations. The control diet will be based on the formula diet Fortimel® (Nutricia Milupa GmbH, Erlangen, Germany). Salt uptake will be standardized employing either broths or salt tablets to not interfere with the steady-state salt and water homeostasis. A salt ingestion of 5g/day, which is common for western diets, is aimed at.

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Fasting mimicking dietActive comparator 1 intervention
Group B: Ketogenic dietActive comparator 1 intervention
Group C: Dietary restriction of sulfur containing amino acidsActive comparator 1 intervention
Group D: Control-GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in proteome levels in pretransplant kidney biopsy samples

Measurement of proteome levels before and after the diet by mass spectrometry

Time frame
at baseline, at end of trial on day 9
2

Changes in phosphoproteome levels in pretransplant kidney biopsy samples

Measurement of phosphoproteome levels before and after the diet by mass spectrometry

Time frame
at baseline, at end of trial on day 9
3

Changes in lipidome levels in pretransplant kidney biopsy samples

Measurement of lipide levels before and after the diet by mass spectrometry

Time frame
at baseline, at end of trial on day 9
4

Changes in epigenome levels in pretransplant kidney biopsy samples

Measurement of epigenome levels before and after the diet by sequencing techniques

Time frame
at baseline, at end of trial on day 9

Secondary outcomes

1

Changes of Insulin-Like Growth-Factor Binding Protein C

Measurement of Insulin-Like Growth Factor Binding Protein C in urine samples

Time frame
at baseline, at the end of trial on day 9
2

Changes of Tissue Inhibitor of Metalloproteinases

Determination in urine as predictive marker for acute kidney injury

Time frame
at baseline, at the end of trial on day 9
3

Changes in Cystatin C

Determination in blood samples as predictive marker for acute kidney injury

Time frame
at baseline, at the end of trial on day 9
4

occurrence of acute kidney injury

Occurrence of acute kidney injury according to the Kidney Disease Improving Global Outcome (KDIGO) criteria

Time frame
at the end of trial on day 9

Other outcomes

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