Investigating the Creation of a Ketogenic State With the Designed 4:1 Keto Classic Formulation in Patients With Traumatic Brain Injury Publisher



Shayanfar S ; Sadeghi N ; Hajimahmoodi M ; Jouibari MF ; Ravari MR ; Mohebbi N
Source: Progress in Neurology and Psychiatry Published:2025

Abstract

The beneficial effects of the ketogenic diet (KD) have been well demonstrated in children with convulsive disorders and epilepsy. Its potential therapeutic impact, primarily through limiting glucose availability to the brain, is currently being investigated in other neurological conditions such as Alzheimer′s and Parkinson′s diseases. Given the neuroprotective properties attributed to this dietary approach, the present study aimed to evaluate its effects in patients with traumatic brain injury (TBI). This randomized, double-blind clinical trial enrolled 20 adult patients with TBI admitted to the intensive care unit (ICU). Participants were randomly assigned to either the intervention or control group according to the inclusion criteria. The primary outcome was the induction of ketosis using the formulated KD. Secondary outcomes included mortality rate, duration of mechanical ventilation, and changes in the Glasgow Coma Scale (GCS). All patients in the intervention group who received the designed ketogenic formulation showed positive urinary ketone tests, confirming ketosis induction. There were no significant differences between groups in mortality rate or duration of mechanical ventilation. However, a significant improvement in GCS was observed within the intervention group between the first and last study days, although intergroup comparison showed no significant difference. The ketogenic diet may contribute to improved neurological recovery, as reflected by GCS impron some patients with TBI. Nevertheless, larger-scale studies are warranted to confirm its efficacy and safety in this population. Clinical Trial Registration: This study was registered in the International Clinical Trials Registry Platform (IRCT) under registration code 20230517058215N1. © 2025 The Author(s). Progress in Neurology and Psychiatry published by John Wiley & Sons Ltd.