Dietary Interventions during Living Kidney Donations (DILKID) - an open-label, randomized controlled pilot trial study protocol

Background: Acute kidney injury (AKI) is a frequent threat in the clinic known for its substantial morbidity and mortality. However, effective therapeutic approaches for AKI are lacking. Specific diets efficiently prevent kidney damage from various stimuli in rodents. Nevertheless, the successful transfer to the patient setting is still lagging behind, since the optimal diet for humans paired with the underlying, but conserved molecular mechanisms remain unknown. Methods: The Dietary Interventions during Living Kidney Donations (DILKID)-Trial is a four-arm, investigator-initiated, randomized controlled trial performed in an academic setting during living kidney donation in humans. Three dietary interventions - a fasting-mimicking diet, a reduced intake of sulfur-containing amino acids, and a ketogenic diet are tested against a standard control diet. Apart from feasibility, safety and tolerability analyses of these beneficial diets at hand, human tissue samples and biofluids are collected in the DILKID-Trial. These tissue samples are the essential basis to recapitulate the underlying molecular mechanisms of diet-organ protection observed in rodents to man. Discussion: The DILKID-Trial is a truly translational pilot-study at the cross-roads of molecular biology, translational nephrology and transplant medicine. Given their strong protective effects in rodent models of AKI, the beneficial diets examined in the DILKID-Trial may substantially add to our therapeutic armamentarium in the clinic. The molecular analyses will provide important mechanistic insight and indicate therapeutic targets for future pharmacological approaches to protect against kidney injury. As the beneficial effects of dietary preconditioning are not limited to the kidney, the DILKID-Trial is a blueprint for further research in the context diet-induced organ protection in the kidney and beyond. ClinicalTrials.gov: NCT05709600, date of registration: 2023-02-02. https://clinicaltrials.gov/study/NCT05709600?a=1