RecruitingNot Applicable

Dietary Interventions During Living Kidney Donations

Germany80 participantsStarted 2023-02-01

Plain-language 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)

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients \> 18 years of age * Planed living kidney transplantation (both donor and recipient are eligible) * Written informed consent Exclusion Criteria: * 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

What they're measuring

Changes in proteome levels in pretransplant kidney biopsy samples

Timeframe: at baseline, at end of trial on day 9

Changes in phosphoproteome levels in pretransplant kidney biopsy samples

Timeframe: at baseline, at end of trial on day 9

Changes in lipidome levels in pretransplant kidney biopsy samples

Timeframe: at baseline, at end of trial on day 9

Changes in epigenome levels in pretransplant kidney biopsy samples

Timeframe: at baseline, at end of trial on day 9

Changes in transcriptome levels in pretransplant kidney biopsy samples

Timeframe: at baseline, at end of trial on day 9

Trial details

NCT IDNCT05709600

SponsorUniversity of Cologne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Felix Köhler, MD

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

View on ClinicalTrials.gov More Living-Kidney Donors trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in proteome levels in pretransplant kidney biopsy samples

Timeframe: at baseline, at end of trial on day 9

Changes in phosphoproteome levels in pretransplant kidney biopsy samples

Timeframe: at baseline, at end of trial on day 9

Changes in lipidome levels in pretransplant kidney biopsy samples

Timeframe: at baseline, at end of trial on day 9

Changes in epigenome levels in pretransplant kidney biopsy samples

Timeframe: at baseline, at end of trial on day 9

Changes in transcriptome levels in pretransplant kidney biopsy samples

Timeframe: at baseline, at end of trial on day 9