Clinical trial · Interventional
The KetoGlioma (Ketogenic Glioma) Study
A Modified Ketogenic, Anti-Inflammatory Diet for Patients With High-Grade Gliomas
NCT05373381CI-TRIAL-00073586withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study is on hold indefinitely due to funding issues.
Summary
Brief summary (as posted)
This research is being conducted to see if patients diagnosed with high grade gliomas can adhere to the supplemented High-Fat Low-Carbohydrate (sHFLC) + KetoPhyt diet, and to see how this diet might affect cancer cells in the bloodstream. This diet is experimental and is not routinely prescribed for patients with high-grade gliomas. The results of this study may be used to support larger studies investigating possible anti-tumor affects of the sHFLC + KetoPhyt diet.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt
- description
- Subjects will adhere to the sHFLC + KetoPhyt diet for six 4-week cycles.
- interventionNames
- Dietary Supplement: Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt
Primary outcomes (1)
- measure
- Number of participants not able to adhere the sHFLC + KetoPhyt Diet
- timeFrame
- From Cycle 1 Day 1 to end of Cycle 6 (Each cycle is 28 days)
- description
- Patients' ability to adhere to the sHFLC + KetoPhyt Diet as defined by the presence of the following: 1. \>75% compliance with taking supplement 2x/day throughout the study period 2. \>75% of days with carbohydrate intake \<33%
Secondary outcomes (3)
- measure
- Change from baseline between the patient's glucose and ketone levels at 24 weeks as assessed by the Glucose/Ketone Index (GKI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with high-grade gliomas (World Health Organization \[WHO\] 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 (XRT), interstitial brachytherapy or radiosurgery, an interval of \> 4 weeks must have elapsed from completion of XRT to pre-registration. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 * Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity from other agents with exception of alopecia. * Steroid dosing stable for at least 7 days * Adequate organ function as defined by the following laboratory values: * Absolute neutrophil count (ANC) ≥ 1500/mm3 * Platelet Count ≥ 100,000/mm3 * Creatinine ≤ 1.5 mg/dl x upper limit of normal (ULN) * Creatinine Clearance ≥ 45 mL/min * Total Bilirubin ≤ 1.5 x ULN (except in cases of Gilbert's disease) * AST (aspartate aminotransferase)/ ALT (alanine transaminase) ≤ 2.5 x ULN Exclusion Criteria: * Concurrent investigational agents or other glioma-directed therapy (chemotherapy, radiation) while on study. * Pregnant or breastfeeding
References
Publications (24)
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- BACKGROUNDCandelario KM, Steindler DA. The role of extracellular vesicles in the progression of neurodegenerative disease and cancer. Trends Mol Med. 2014 Jul;20(7):368-74. doi: 10.1016/j.molmed.2014.04.003. Epub 2014 May 14. PMID 24835084
- BACKGROUNDCandelario KM, Balaj L, Zheng T, Skog J, Scheffler B, Breakefield X, Schule B, Steindler DA. Exosome/microvesicle content is altered in leucine-rich repeat kinase 2 mutant induced pluripotent stem cell-derived neural cells. J Comp Neurol. 2020 May;528(7):1203-1215. doi: 10.1002/cne.24819. Epub 2019 Nov 30. PMID 31743443
- BACKGROUNDChamp CE, Palmer JD, Volek JS, Werner-Wasik M, Andrews DW, Evans JJ, Glass J, Kim L, Shi W. Targeting metabolism with a ketogenic diet during the treatment of glioblastoma multiforme. J Neurooncol. 2014 Mar;117(1):125-31. doi: 10.1007/s11060-014-1362-0. Epub 2014 Jan 19. PMID 24442482
- BACKGROUNDFadrosh DW, Ma B, Gajer P, Sengamalay N, Ott S, Brotman RM, Ravel J. An improved dual-indexing approach for multiplexed 16S rRNA gene sequencing on the Illumina MiSeq platform. Microbiome. 2014 Feb 24;2(1):6. doi: 10.1186/2049-2618-2-6. PMID 24558975
- BACKGROUNDKlein P, Tyrlikova I, Mathews GC. Dietary treatment in adults with refractory epilepsy: a review. Neurology. 2014 Nov 18;83(21):1978-85. doi: 10.1212/WNL.0000000000001004. Epub 2014 Oct 29. PMID 25355830
- BACKGROUNDLiu L, Duff K. A technique for serial collection of cerebrospinal fluid from the cisterna magna in mouse. J Vis Exp. 2008 Nov 10;(21):960. doi: 10.3791/960.