Dietary Interventions During Living Kidney Donations (NCT05709600) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in proteome levels in pretransplant kidney biopsy samples
Timeframe: at baseline, at end of trial on day 9
2
Changes in phosphoproteome levels in pretransplant kidney biopsy samples
Timeframe: at baseline, at end of trial on day 9
3
Changes in lipidome levels in pretransplant kidney biopsy samples
Timeframe: at baseline, at end of trial on day 9
4
Changes in epigenome levels in pretransplant kidney biopsy samples
Timeframe: at baseline, at end of trial on day 9
5
Changes in transcriptome levels in pretransplant kidney biopsy samples