Clinical trial · Interventional
Glioma Modified Atkins-based Diet in Patients With Glioblastoma
The Feasibility and Biologic Effect of a Modified Atkins-based Intermittent Fasting Diet in Patients With Glioblastoma (GBM)
NCT02286167CI-TRIAL-00106305GLADcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary goal of this study is to assess the feasibility and biologic activity of a modified Atkins-based diet combined with short-term intermittent fasting, a GLioma Atkins-based Diet (GLAD), in patients with central nervous system GBM.
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 |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet modification | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single arm diet
- description
- Intermittent, modified Atkins diet
- interventionNames
- Other: Diet modification
Primary outcomes (1)
- measure
- Feasibility of intermittent modified Atkins diet in patients with GBM assessed by percent of patients able to remain on the diet and achieve nutritional goals
- timeFrame
- 8 weeks per patient
- description
- Percent of patients able to remain on the diet and achieve nutritional goals as defined by cumulative assessment of diet records collected at weeks 4, 6, and 8 with a 60% completion defined as a positive results
Secondary outcomes (3)
- measure
- Biologic activity measured by pre- and post-study cerebral glutamate and glutamine concentrations assessed by MRS.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have a clinical and histopathologic diagnosis of GBM, have completed \>80% of prescribed concurrent radiation therapy and adjuvant temozolomide without CTCEA grade 3 or 4 toxicity, and be greater than 7 months from the time of completion of concurrent chemoradiotherapy. 2. Karnofsky performance status \>/= 60. 3. Patients must be at least 18 years of age. 4. Patients must be eligible to undergo a ketogenic or Atkins based diet according to baseline body mass index (BMI, see exclusion criteria), comorbid medical conditions (see exclusion criteria), and baseline laboratory assessment (see exclusion criteria). 5. Patients must be of appropriate mental capacities with sufficient social support so as to be able to complete required study activities (i.e. diet record, etc) and able to provide written informed consent. Exclusion Criteria: 1. Patients with a history of a metabolic disorder including documented defect in urea metabolism (including documented history of gout), carnitine deficiency (primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency), fatty acid metabolism, beta-oxidation defects, pyruvate carboxylase deficiency, mitochondrial function, porphyria, or nephrolithiasis. 2. Severe acute infection. 3. BMI \> 35.0 or BMI \< 20.0. 4. Active bowel obstruction, ileus, or active or remote pancreatitis. 5. Clinically significant heart failure (NYHA \>2), recent myocardial infarction, or symptomatic atrial fibrillation. 6. Clinically significant renal disease (creatinine \>2.0 mg/dL, urea \>100 mg/dL). 7. Clinically significant hepatic dysfunction (alanine or aspartate aminotransferase \>7 times the upper limit of normal). 8. Patients with insulin-dependent diabetes mellitus. 9. Conditions that may increase the risk of the diet or significantly reduce compliance (i.e. cognitive impairment, frank dementia, etc). 10. Other concurrent experimental therapies. 11. Milk allergy. 12. Treatment with the modified Atkins diet (MAD) for any cause within the 9 months prior to study enrollment 13. Patient inability to complete baseline screening 3-day diet record.
References
Publications (1)
- DERIVEDSchreck KC, Hsu FC, Berrington A, Henry-Barron B, Vizthum D, Blair L, Kossoff EH, Easter L, Whitlow CT, Barker PB, Cervenka MC, Blakeley JO, Strowd RE. Feasibility and Biological Activity of a Ketogenic/Intermittent-Fasting Diet in Patients With Glioma. Neurology. 2021 Aug 31;97(9):e953-e963. doi: 10.1212/WNL.0000000000012386. Epub 2021 Jul 7. PMID 34233941