TY - JOUR A1 - Voß, Martin A1 - Wenger-Alakmeh, Katharina Johanna A1 - Mettenheim, Nina von A1 - Bojunga, Jörg A1 - Vetter, Manuela A1 - Diehl, Bianca A1 - Franz, Kea A1 - Gerlach, Rüdiger A1 - Ronellenfitsch, Michael Wilfried A1 - Harter, Patrick Nikolaus A1 - Hattingen, Elke A1 - Steinbach, Joachim Peter A1 - Rödel, Claus A1 - Rieger, Johannes T1 - Short-term fasting in glioma patients: analysis of diet diaries and metabolic parameters of the ERGO2 trial T2 - European journal of nutrition N2 - Purpose: The prospective, randomized ERGO2 trial investigated the effect of calorie-restricted ketogenic diet and intermittent fasting (KD-IF) on re-irradiation for recurrent brain tumors. The study did not meet its primary endpoint of improved progression-free survival in comparison to standard diet (SD). We here report the results of the quality of life/neurocognition and a detailed analysis of the diet diaries. Methods: 50 patients were randomized 1:1 to re-irradiation combined with either SD or KD-IF. The KD-IF schedule included 3 days of ketogenic diet (KD: 21–23 kcal/kg/d, carbohydrate intake limited to 50 g/d), followed by 3 days of fasting and again 3 days of KD. Follow-up included examination of cognition, quality of life and serum samples. Results: The 20 patients who completed KD-IF met the prespecified goals for calorie and carbohydrate restriction. Substantial decreases in leptin and insulin and an increase in uric acid were observed. The SD group, of note, had a lower calorie intake than expected (21 kcal/kg/d instead of 30 kcal/kg/d). Neither quality of life nor cognition were affected by the diet. Low glucose emerged as a significant prognostic parameter in a best responder analysis. Conclusion: The strict caloric goals of the ERGO2 trial were tolerated well by patients with recurrent brain cancer. The short diet schedule led to significant metabolic changes with low glucose emerging as a candidate marker of better prognosis. The unexpected lower calorie intake of the control group complicates the interpretation of the results. Clinicaltrials.gov number: NCT01754350; Registration: 21.12.2012. KW - Glioblastoma KW - Radiation KW - Ketogenic diet KW - Fasting KW - Glucose KW - Leptin Y1 - 2021 UR - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/63759 UR - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-637598 SN - 1436-6215 N1 - Open Access funding enabled and organized by Projekt DEAL. The Senckenberg Institute of Neurooncology is supported by the Senckenberg Foundation. This trial was funded by the investigator-initiated trial (IIT) program of the University Cancer Center Frankfurt (UCT). Ketogenic drinks were supplied by Tavarlin® without costs. Neither the UCT nor Tavarlin® had any involvement in the clinical trial itself or the writing of the report. N1 - Version of Record: http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:hebis:30:3-627941 N1 - Early View: Online Version before inclusion in an issue. VL - 2021 IS - online version before inclusion in an issue PB - Steinkopff CY - Darmstadt ER -