A Modified Ketogenic, Anti‐Inflammatory Diet for Patients with High‐Grade Gliomas

A Modified Ketogenic, Anti-Inflammatory Diet for Patients with High-Grade Gliomas

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Glioblastoma
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Overview
Principal Investigator: Suriya Jeyapalan, MD

This is a phase I trial to see whether patients are able to adhere to a modified, high fat/low carbohydrate diet (the sHFLC + KetoPhyt Diet) with a supplement named KetoPhyt that includes ketones and anti-inflammatory properties.

The classic ketogenic diet (KD) is difficult for patients to adhere to due to its stringent nature. A modified KD has been developed that mimics the glucose lowering, ketone raising effects and the anti-cancer outcomes of the KD.

The sHFLC + KetoPhyt diet will be implemented in a cohort of 10 Glioblastoma patients, who will be trained and provided with sample meal plans so as to maintain their carbohydrate levels up to 33% of total caloric intake. The study will determine whether participants can maintain the diet and the ketogenic state.

This study will also conduct molecular analyses to determine the effect of the diet on the microbiome, inflammatory cytokines, and extracellular vesicle content.

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Sarah Sexton

Study details
Inclusion Criteria
  • Patients with high-grade gliomas (WHO grade III/IV) with newly diagnosed or recurrent disease
  • Ability to understand and willingness to sign an informed consent form prior to any study procedures
  • For patients treated with external beam radiation, interstitial brachytherapy or radiosurgery, an interval of > 4 weeks must have elapsed from completion of XRT to pre-registration.
Exclusion Criteria
  • Concurrent investigational agents or other glioma-directed therapy (chemotherapy, radiation) while on study
  • Pregnant or breastfeeding
  • Investigational agents within 28 days of study treatment. FDA-approved therapies for disease state are allowed.
Study Requirements

Ten patients with high-grade gliomas, either newly diagnosed or recurrent, will be enrolled over the course of a year. Subjects will participate in the study for up to 28 weeks. Screening will last for up to 4 weeks. Following the screening period, subjects will adhere to the sHFLC + KetoPhyt diet for six 4-week cycles. Upon completion of the 6th cycle, patients will return to the clinic for the final “End of Treatment” study visit.

Patients will receive dietary advice from a Registered Dietitian (RD) to allow for the of design personalized meal plans maintaining carbohydrates up to 33% of total caloric intake, and be asked to maintain a daily dietary log.

To assist patients in understanding, monitoring and controlling their dietary choices to maintain a low carbohydrate diet, they will be trained and receive assistance on the use of an online tool for tracking nutrition [Healthtrac].

Compliance to the low carbohydrate diet will be monitored weekly via the online nutrition tracking tool, Healthtrac, and monthly with the daily dietary log. The criteria to determine compliance will be calculated with these two tools with the goal being to maintain a mean of 33% of daily caloric intake from carbohydrates. [LC3] If the patient’s diet falls outside of this range this will be addressed on the monthly visit with the RD who can discuss options and strategies to maintain the 33% carbohydrate caloric intake.