Dietary Interventions During Living Kidney Donations

NCT05709600 | Recruiting

• 1 other identifier: V1.1-25052022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 vs. ketogenic diet vs. dietary restriction of sulfur containing amino acids vs. control patients)

Conditions

Living-Kidney Donors

Keywords

Transplant; Acute Kidney Injury; Kidney Dietary Interventions

Outcome Measures

Primary Outcomes (5)

• Changes in proteome levels in pretransplant kidney biopsy samples

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

  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

  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

  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

  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

  at baseline, at end of trial on day 9

Secondary Outcomes (6)

• Changes of Insulin-Like Growth-Factor Binding Protein C

  at baseline, at the end of trial on day 9

• Changes of Tissue Inhibitor of Metalloproteinases

  at baseline, at the end of trial on day 9

• Changes in Cystatin C

  at baseline, at the end of trial on day 9

• occurrence of acute kidney injury

  at the end of trial on day 9

• maximum serum creatinine in the recipient during hospitalization

  during hospitalization, an average of 7 days, six weeks after transplantation and six month after transplantation

Study Arms (4)

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.

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).

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).

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)

Dietary Supplement: Control Group ( healthy, low-fat, moderate protein and high carbohydrate diet)

Interventions

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.

Fasting mimicking 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

Ketogenic diet

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.

Dietary restriction of sulfur containing amino acids

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.

Control-Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years of age
• Planed living kidney transplantation (both donor and recipient are eligible)
• Written informed consent

You may not qualify if:

• 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
• Pregnancy
• Breastfeeding
• Absence of safe contraceptive measures or non-occurrence of menopause (in women)
• Participation in other interventional trials

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Department II of Internal Medicine, Center for Molecular Medicine Cologne (CMMC), University Hospital of Cologne

Cologne, 50931, Germany

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Diet, Ketogenic; Control Groups; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Roman-Ulrich Müller, Prof. MD

  Department II of Internal Medicine, University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Köhler, MD

CONTACT

+49 221 478 97222; felix.koehler@uk-koeln.de

Roman-Ulrich Müller, Prof. MD

CONTACT

+49 221 478 97222

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 2, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)