Living-Kidney DonorsDILKIDNCT05709600
Dietary Interventions During Living Kidney Donations
A study testing Fasting mimicking diet, Ketogenic diet and Dietary restriction of sulfur containing amino acids in people with Living-Kidney Donors, run by University of Cologne at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Living-Kidney Donors
- What is being tested?
- Fasting mimicking diet, Ketogenic diet and Dietary restriction of sulfur containing amino acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients > 18 years of age
- Planed living kidney transplantation (both donor and recipient are eligible)
- Written informed consent
Who cannot join
- Vegetarian lifestyle
- Body-Mass-Index (BMI) < 18.5 kg/m2
- Calorie-reduced diet within the preceding four weeks
- Underlying wasting syndrome
- Contraindication for enteral nutrition
- Known allergy to or intolerance of the ingredients of the diet used
Show all 10Show fewer
- Pregnancy
- Breastfeeding
- Absence of safe contraceptive measures or non-occurrence of menopause (in women)
- Participation in other interventional trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Roman-Ulrich Müller, Prof. MD contact
Germany1 site, 1 recruiting
- Recruiting
Department II of Internal Medicine, Center for Molecular Medicine Cologne (CMMC), University Hospital of Cologne
Cologne, 50931
Felix Köhler, MD, +49 221 478 97222, felix.koehler@uk-koeln.de
Roman-Ulrich Müller, Prof. MD, +49 221 478 97222, roman-ulrich.mueller@uk-koeln.de
About this study
Official title: Dietary Interventions During Living Kidney Donations (DILKID 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)
Read the detailed description
Acute kidney injury (AKI) is one of the most common disorders in hospitalized patients and the incidence of AKI is rapidly rising, especially among high-risk patients. In a meta-analysis including 49 million patients, AKI occurred in every fifth adult and in every third children suffering from an acute illness, defined as critical care with admission to the intensive care unit (ICU), cardiac surgery, trauma, heart failure or underlying disease within the field of haematology/oncology. AKI is associated with substantial mortality, even in non-ICU patients mortality ranges high between 10-20% and AKI severity is related to increased mortality. In addition, non-recovery of kidney function rates between 13-29% and progression to chronic kidney disease (CKD) requiring dialysis after AKI is common. Despite the considerable burden associated with AKI, effective therapeutic approaches, including prevention strategies, are currently lacking.
Since impaired cellular stress resistance contributes to AKI, preconditioning protocols that augment stress resistance such as caloric restriction (CR) are attractive strategies in the search for organprotection. CR protects from kidney damage in rodent models of AKI, induced by either ischemia-reperfusion injury or by injection of nephrotoxic cisplatin. However, the translation of this potential to the clinical setting has been hampered by both the limited understanding of the underlying mechanisms paired with the risk of malnourishment and significant comorbidity in the target patient population in terms of frailty, multi-morbidity or preoperative settings.
Based on more recent results regarding novel dietary regimens, three well-established targeted diets (a fasting mimicking diet, a ketogenic diet and the dietary restriction of sulfur-containing amino acids and the dietary restriction of branched chained amino acids), which already proved their safety and feasibility in both phase-II and I clinical trials, are promising novel targeted dietary strategies beyond CR.
Intermittent fasting with fasting mimicking diets enables the activation of cellular signal transduction similar to CR with high nourishment. Fasting mimicking diet efficiently protects from acute kidney injury in rodents. Human FMD (Prolon®) is a plant-derived diet to achieve fasting-like effects on serum levels of insulin growth factor-1 (IGF-1), insulin growth factor protein-1 (IGFP-1), glucose and ketone bodies, while providing both macro- und micronutrients. Intermitted fasting with fasting mimicking diets have extensively been studied in rodents. Additionally, phase-II and phase-I studies proofed safety, feasibility and favorable outcome in healthy volunteers and patients with autoimmune disorders or diabetes.
Ketogenic diets are high in fat and very low in carbohydrates and result in ketogenesis with the synthesis of ketone bodies, exceeding β-oxidation of fatty acids and anti-inflammation. Furthermore, ketogenic diets extend the lifespan in rodents with preserved physiological functions. Ketone bodies, such as β-hydroxybutyrate, suppress oxidative stress resulting in nephroprotection. Due to their additional neuroprotective effects, ketogenic diets have been in medical use in pharmacoresistant epilepsy proofing their feasibility and safety in humans. Moreover, ketogenic diets in women with ovarian and endometrial cancer revealed favorable effects on physical activity, perceived energy and food cravings. Considering that CR actually does induce ketogenesis due to feeding cycles, ketogenic diets are a key strategy that needs to be examined as a replacement for caloric restriction.
The amino acid methionine is the start codon in protein translation and is essential in the synthesis of the amino acid cysteine, which is also a precursor for glutathione and s adenosylmethionine, both needed in detoxification and methylation. Dietary restriction of these two sulfur-containing amino acids has been shown to be required for the beneficial effects of caloric restriction in a rodent model of liver damage. In addition, restriction in sulfur containing amino acids efficiently protects from acute kidney injury in rodents. Cysteine/methionine restriction activates the transsulfuration pathway resulting in the generation of hydrogen sulfide (H2S) and is associated with anti-inflammation, increased stress resistance, reduction of reactive oxygen species and alteration in lipid-metabolism. Sulfur containing amino acids are abundant in animal-derived protein, but also exist in certain vegetables, fruits and grains. A dietary restriction of sulfur containing amino acids can be achieved by a vegan-based diet without fish, meat, dairy products and certain plant-based foods as well as using specific formula diets Objective of the proof-of-principle, pilot-DILKID-trial is to decipher the underlying mediating mechanisms of different, well-established, dietary regimens as well as to prove their feasibility, tolerability and safety in nephrology patients. Additionally, the organprotective effects of those preoperative dietary interventions in terms of the transplant function in the kidney recipient will be analyzed. Inter-group differences on transcriptome, lipidome, metabolome, epigenome and (phospho-) proteome in the collected tissue (kidney, vessel and fat tissue), as well as in blood cells, plasma and serum will be compared between the different study arms.
In addition, the DILKID-trial aims to prove nephroprotective effects observed in rodent studies in humans and to correlate them with clinical surrogate parameters for kidney function. Another goal of our study consists in the identification of distinct metabolic pathways that are mediated by the dietary preconditioning strategies mentioned above and resulting in novel therapeutic approach protecting from AKI in nephrology patients
- Conditions
- Living-Kidney Donors
- Being tested
- Fasting mimicking diet, Ketogenic diet, Dietary restriction of sulfur containing amino acids, Control Group ( healthy, low-fat, moderate protein and high carbohydrate diet)
- Keywords
- Transplant, Acute Kidney Injury, Kidney Dietary Interventions
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting mimicking dietDietary 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 dietDietary 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 acidsDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Fasting mimicking diet | Active comparator | Human fasting mimicking diet (Prolon®) for five days prior to living kidney donation in donor: Day 1 of Prolon® supplies ~4600 kJ, day 2-5 provide ~3000kJ. Receives: Dietary Supplement: Fasting mimicking diet |
| Ketogenic diet | Active comparator | Isocaloric, ketogenic diet 7 days prior to living kidney donation in the kidney donor with below 5% of energy from carbohydrate (<20g/day), approximately 15% from protein (<100g/day) and 80% from fat (>125g/day) without changes in caloric supply calculated by the Mifflin-St.Jeor formula achieved by the KetoCal 4:1 formula diet (Nutricia Milupa GmbH, Erlangen, Germany). Receives: Dietary Supplement: Ketogenic diet |
| Dietary restriction of sulfur containing amino acids | Active comparator | Isocaloric, dietary restriction of sulfur containing amino acids in the donor without changes in caloric supply calculated by the Mifflin-St.Jeor formula achieved by the X Met X Cys Maxamaid formula diet (Nutricia Milupa GmbH, Erlangen, Germany). Receives: Dietary Supplement: Dietary restriction of sulfur containing amino acids |
| Control-Group | Active comparator | Healthy, low-fat, moderate protein and high carbohydrate diet in the donor as described in the current nutritional recommendations of the American Diabetes Association achieved by the Fortimel® diet (Nutricia Milupa GmbH, Erlangen, Germany) Receives: Dietary Supplement: Control Group ( healthy, low-fat, moderate protein and high carbohydrate diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in proteome levels in pretransplant kidney biopsy samples
Measurement of proteome levels before and after the diet by mass spectrometry
Measured: at baseline, at end of trial on day 9
Changes in phosphoproteome levels in pretransplant kidney biopsy samples
Measurement of phosphoproteome levels before and after the diet by mass spectrometry
Measured: at baseline, at end of trial on day 9
Changes in lipidome levels in pretransplant kidney biopsy samples
Measurement of lipide levels before and after the diet by mass spectrometry
Measured: at baseline, at end of trial on day 9
Changes in epigenome levels in pretransplant kidney biopsy samples
Measurement of epigenome levels before and after the diet by sequencing techniques
Measured: at baseline, at end of trial on day 9
Changes in transcriptome levels in pretransplant kidney biopsy samples
Measurement of transcriptome levels before and after the diet by sequencing techniques
Measured: at baseline, at end of trial on day 9
Secondary outcomes (6)
Changes of Insulin-Like Growth-Factor Binding Protein C
Measurement of Insulin-Like Growth Factor Binding Protein C in urine samples
Measured: at baseline, at the end of trial on day 9
Changes of Tissue Inhibitor of Metalloproteinases
Determination in urine as predictive marker for acute kidney injury
Measured: at baseline, at the end of trial on day 9
Changes in Cystatin C
Determination in blood samples as predictive marker for acute kidney injury
Measured: at baseline, at the end of trial on day 9
occurrence of acute kidney injury
Occurrence of acute kidney injury according to the Kidney Disease Improving Global Outcome (KDIGO) criteria
Measured: at the end of trial on day 9
maximum serum creatinine in the recipient during hospitalization
Measurement of serum creatinine levels in blood samples
Measured: during hospitalization, an average of 7 days, six weeks after transplantation and six month after transplantation
Feasibility of dietary interventions in every-day life
Patient-reported feasibility will be measured using visual analogue scale (VAS), where min. 0 the worst outcome and max. 100 the best outcome means
Measured: during 7 days of dietary intervention, at the end of trial on day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Feb 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living-Kidney DonorsStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roman Müller, University of Cologne
- Investigators
- Roman-Ulrich Müller, Prof. MD, Principal investigator, Department II of Internal Medicine, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709600
- Sponsor's protocol ID
- V1.1-25052022
- Acronym
- DILKID
- Status last verified
- Apr 2026
- First submitted
- 10 Jan 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Interventions During Living Kidney Donations (DILKID Trial)
- ClinicalTrials.gov ID
- NCT05709600
- Acronym / sponsor ID
- DILKID / V1.1-25052022
- Conditions
- Living-Kidney Donors
- Keywords
- Transplant, Acute Kidney Injury, Kidney Dietary Interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Feb 2023 (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.
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)
Detailed description
Acute kidney injury (AKI) is one of the most common disorders in hospitalized patients and the incidence of AKI is rapidly rising, especially among high-risk patients. In a meta-analysis including 49 million patients, AKI occurred in every fifth adult and in every third children suffering from an acute illness, defined as critical care with admission to the intensive care unit (ICU), cardiac surgery, trauma, heart failure or underlying disease within the field of haematology/oncology. AKI is associated with substantial mortality, even in non-ICU patients mortality ranges high between 10-20% and AKI severity is related to increased mortality. In addition, non-recovery of kidney function rates between 13-29% and progression to chronic kidney disease (CKD) requiring dialysis after AKI is common. Despite the considerable burden associated with AKI, effective therapeutic approaches, including prevention strategies, are currently lacking.
Since impaired cellular stress resistance contributes to AKI, preconditioning protocols that augment stress resistance such as caloric restriction (CR) are attractive strategies in the search for organprotection. CR protects from kidney damage in rodent models of AKI, induced by either ischemia-reperfusion injury or by injection of nephrotoxic cisplatin. However, the translation of this potential to the clinical setting has been hampered by both the limited understanding of the underlying mechanisms paired with the risk of malnourishment and significant comorbidity in the target patient population in terms of frailty, multi-morbidity or preoperative settings.
Based on more recent results regarding novel dietary regimens, three well-established targeted diets (a fasting mimicking diet, a ketogenic diet and the dietary restriction of sulfur-containing amino acids and the dietary restriction of branched chained amino acids), which already proved their safety and feasibility in both phase-II and I clinical trials, are promising novel targeted dietary strategies beyond CR.
Intermittent fasting with fasting mimicking diets enables the activation of cellular signal transduction similar to CR with high nourishment. Fasting mimicking diet efficiently protects from acute kidney injury in rodents. Human FMD (Prolon®) is a plant-derived diet to achieve fasting-like effects on serum levels of insulin growth factor-1 (IGF-1), insulin growth factor protein-1 (IGFP-1), glucose and ketone bodies, while providing both macro- und micronutrients. Intermitted fasting with fasting mimicking diets have extensively been studied in rodents. Additionally, phase-II and phase-I studies proofed safety, feasibility and favorable outcome in healthy volunteers and patients with autoimmune disorders or diabetes.
Ketogenic diets are high in fat and very low in carbohydrates and result in ketogenesis with the synthesis of ketone bodies, exceeding β-oxidation of fatty acids and anti-inflammation. Furthermore, ketogenic diets extend the lifespan in rodents with preserved physiological functions. Ketone bodies, such as β-hydroxybutyrate, suppress oxidative stress resulting in nephroprotection. Due to their additional neuroprotective effects, ketogenic diets have been in medical use in pharmacoresistant epilepsy proofing their feasibility and safety in humans. Moreover, ketogenic diets in women with ovarian and endometrial cancer revealed favorable effects on physical activity, perceived energy and food cravings. Considering that CR actually does induce ketogenesis due to feeding cycles, ketogenic diets are a key strategy that needs to be examined as a replacement for caloric restriction.
The amino acid methionine is the start codon in protein translation and is essential in the synthesis of the amino acid cysteine, which is also a precursor for glutathione and s adenosylmethionine, both needed in detoxification and methylation. Dietary restriction of these two sulfur-containing amino acids has been shown to be required for the beneficial effects of caloric restriction in a rodent model of liver damage. In addition, restriction in sulfur containing amino acids efficiently protects from acute kidney injury in rodents. Cysteine/methionine restriction activates the transsulfuration pathway resulting in the generation of hydrogen sulfide (H2S) and is associated with anti-inflammation, increased stress resistance, reduction of reactive oxygen species and alteration in lipid-metabolism. Sulfur containing amino acids are abundant in animal-derived protein, but also exist in certain vegetables, fruits and grains. A dietary restriction of sulfur containing amino acids can be achieved by a vegan-based diet without fish, meat, dairy products and certain plant-based foods as well as using specific formula diets Objective of the proof-of-principle, pilot-DILKID-trial is to decipher the underlying mediating mechanisms of different, well-established, dietary regimens as well as to prove their feasibility, tolerability and safety in nephrology patients. Additionally, the organprotective effects of those preoperative dietary interventions in terms of the transplant function in the kidney recipient will be analyzed. Inter-group differences on transcriptome, lipidome, metabolome, epigenome and (phospho-) proteome in the collected tissue (kidney, vessel and fat tissue), as well as in blood cells, plasma and serum will be compared between the different study arms.
In addition, the DILKID-trial aims to prove nephroprotective effects observed in rodent studies in humans and to correlate them with clinical surrogate parameters for kidney function. Another goal of our study consists in the identification of distinct metabolic pathways that are mediated by the dietary preconditioning strategies mentioned above and resulting in novel therapeutic approach protecting from AKI in nephrology patients
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fasting mimicking diet | Active comparator | Dietary Supplement: Fasting mimicking dietHuman fasting mimicking diet (Prolon®) for five days prior to living kidney donation in donor: Day 1 of Prolon® supplies ~4600 kJ, day 2-5 provide ~3000kJ. |
| Ketogenic diet | Active comparator | Dietary Supplement: Ketogenic dietIsocaloric, ketogenic diet 7 days prior to living kidney donation in the kidney donor with below 5% of energy from carbohydrate (<20g/day), approximately 15% from protein (<100g/day) and 80% from fat (>125g/day) without changes in caloric supply calculated by the Mifflin-St.Jeor formula achieved by the KetoCal 4:1 formula diet (Nutricia Milupa GmbH, Erlangen, Germany). |
| Dietary restriction of sulfur containing amino acids | Active comparator | Dietary Supplement: Dietary restriction of sulfur containing amino acidsIsocaloric, dietary restriction of sulfur containing amino acids in the donor without changes in caloric supply calculated by the Mifflin-St.Jeor formula achieved by the X Met X Cys Maxamaid formula diet (Nutricia Milupa GmbH, Erlangen, Germany). |
| Control-Group | Active comparator | Dietary Supplement: Control Group ( healthy, low-fat, moderate protein and high carbohydrate diet)Healthy, low-fat, moderate protein and high carbohydrate diet in the donor as described in the current nutritional recommendations of the American Diabetes Association achieved by the Fortimel® diet (Nutricia Milupa GmbH, Erlangen, Germany) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 18 years of age
- Planed living kidney transplantation (both donor and recipient are eligible)
- Written informed consent
Key exclusion criteria (10 listed)
- Vegetarian lifestyle
- Body-Mass-Index (BMI) < 18.5 kg/m2
- Calorie-reduced diet within the preceding four weeks
- Underlying wasting syndrome
- Contraindication for enteral nutrition
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 |
|---|---|---|
| Fasting mimicking dietIntermittent 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. | Dietary supplement | Fasting mimicking diet |
| Ketogenic dietIsocaloric, 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 supplement | Ketogenic diet |
| Dietary restriction of sulfur containing amino acidsIsocaloric, 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. | Dietary supplement | Dietary restriction of sulfur containing amino acids |
| Control Group ( healthy, low-fat, moderate protein and high carbohydrate diet)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. | Dietary supplement | Control-Group |
Primary outcome
Changes in proteome levels in pretransplant kidney biopsy samples
Time frame: at baseline, at end of trial on day 9
Measurement of proteome levels before and after the diet by mass spectrometry
Changes in phosphoproteome levels in pretransplant kidney biopsy samples
Time frame: at baseline, at end of trial on day 9
Measurement of phosphoproteome levels before and after the diet by mass spectrometry
Changes in lipidome levels in pretransplant kidney biopsy samples
Time frame: at baseline, at end of trial on day 9
Measurement of lipide levels before and after the diet by mass spectrometry
Changes in epigenome levels in pretransplant kidney biopsy samples
Time frame: at baseline, at end of trial on day 9
Measurement of epigenome levels before and after the diet by sequencing techniques
Changes in transcriptome levels in pretransplant kidney biopsy samples
Time frame: at baseline, at end of trial on day 9
Measurement of transcriptome levels before and after the diet by sequencing techniques
6 secondary outcomes
Changes of Insulin-Like Growth-Factor Binding Protein C
Time frame: at baseline, at the end of trial on day 9
Changes of Tissue Inhibitor of Metalloproteinases
Time frame: at baseline, at the end of trial on day 9
Changes in Cystatin C
Time frame: at baseline, at the end of trial on day 9
occurrence of acute kidney injury
Time frame: at the end of trial on day 9
maximum serum creatinine in the recipient during hospitalization
Time frame: during hospitalization, an average of 7 days, six weeks after transplantation and six month after transplantation
Feasibility of dietary interventions in every-day life
Time frame: during 7 days of dietary intervention, at the end of trial on day 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Roman-Ulrich Müller, Prof. MD contact
Roman-Ulrich Müller, Prof. MD principal investigator
Department II of Internal Medicine, University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting mimicking diet, Ketogenic diet and Dietary restriction of sulfur containing amino acids in people with Living-Kidney Donors, run by University of Cologne at 1 site in Germany.
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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felix Köhler, MD (+49 221 478 97222, felix.koehler@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in proteome levels in pretransplant kidney biopsy samples (time frame: at baseline, at end of trial on day 9). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2026.