Fasting before living-kidney donation: effect on donor well-being and postoperative recovery: study protocol of a multicenter randomized controlled trial

Abstract

Background One of the main effectors on the quality of life of living-kidney donors is postoperative fatigue. Caloric restriction (CR) and short-term fasting (STF) are associated with improved fitness and increased resistance to acute stress. CR/STF increases the expression of cytoprotective genes, increases immunomodulation via increased anti-inflammatory cytokine production, and decreases the expression of pro-inflammatory markers. As such, nutritional preconditioning by CR or STF represents a non-invasive and cost-effective method that could mitigate the effects of acute surgery-induced stress and postoperative fatigue. To investigate whether preoperative STF contributes to a reduction in fatigue after living-kidney donation, a randomized clinical trial is indicated. Methods We aim to determine whether 2.5 days of fasting reduces postoperative fatigue score in subjects undergoing living-kidney donation. In this randomized study, the intervention group will follow a preoperative fasting regime for 2.5 days with a low-dose laxative, while the control group will receive standard care. The main study endpoint is postoperative fatigue, 4 weeks after living-kidney donation. Secondary endpoints include the effect of preoperative fasting on postoperative hospital admission time, the feasibility of STF, and the postoperative recovery of donor and recipient kidney function. This study will provide us with knowledge of the feasibility of STF and confirm its effect on postoperative recovery. Discussion Our study will provide clinically relevant information on the merits of caloric restriction for living-kidney donors and recipients. We expect to reduce the postoperative fatigue in living-kidney donors and improve the postoperative recovery of living-kidney recipients. It will provide evidence on the clinical merits and potential caveats of preoperative dietary interventions. Trial registration Netherlands Trial Register NL9262. EudraCT 2020-005445-16. MEC Erasmus MC MEC-2020-0778. CCMO NL74623.078.21

Do treats facilitate the interpretation of findings on caloric restriction?

“…This was not as expected, given that on average, women tend to crave sweet treats more than men 37 38. Lastly, study personnel were found to significantly rate lower, influenced by their involvement in the active trials,29–31 possibly setting higher standards for the coordinating investigator or they were just sad to see a familiar batch of brownies distributed to others. The consistent findings in the subscores support the absence of the ‘Brownie-Effect’.…”

“…We selected 200 email addresses of healthcare professionals from departments associated with the active clinical trials 29–31. The survey was sent twice, on 26 April 2023 and 10 May 2023, and people were given a response window of 6 weeks from 26 April 2023.…”

“…Contents and protocol on this investigational product have been published earlier 6. At the start of the presentation, colleagues were informed about the content of the presentation; an update on the active clinical trials investigating STF 29–31. After this brief introduction, they received information about the current randomised study.…”

“…We hypothesise that providing a treat positively influences the score given by participants who are not familiar with fasting, while not or negatively influencing the participants who are familiar with it. By combining two studies we hope to shed light on the factors that shape the attitudes of medical professionals toward research into fasting, to facilitate successful implementation of potential findings of current research,29–31 and ultimately contribute to evidence-based strategies. In summary, our study explores the effect of treats offered as a treat during presentations about IF and STF, while accounting for the irony of the situation: a calorie-rich brownie versus the information on the potential health benefits of restricting calories.…”

Effects of Prolonged Fasting During Inpatient Multimodal Treatment on Pain and Functional Parameters in Knee and Hip Osteoarthritis: A Prospective Exploratory Observational Study

“…We suggest three main pathomechanisms for symptom reduction in OA through fasting. One is the anti-inflammatory effect of fasting that has been shown in animal and human studies (5,13,34,55). This is probably mediated by cellular stress-response mechanisms such as autophagy, mitophagy and sirtuine-activation, as well as systemic hormonal and metabolic responses to nutrient deprivation (5,56).…”