N/A
Completed N=12
Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma
Source: ClinicalTrials.gov NCT03278249 ↗Enrolled (actual)
12
Serious AEs
66.7%
Results posted
Sep 2024
Primary outcomePrimary: Number of Participants With Ketosis — 9 Participants
Summary
The purpose of this research study is to see if people can produce ketones in their blood with the modified Atkins diet. Modified Atkins diet is a diet that produces ketones in your blood by restricting carbohydrates to <20 grams per day. Ketones are substances that are produced in the blood when fat is being broken down. Ketones may help radiation work better and may starve your tumor because it is thought that some brain tumors can not use ketones to grow and can only use sugar or glucose to grow.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Ketosis |
9 | — |
| SECONDARY Number of Participants With Progression Free Survival |
6 | — |
| SECONDARY Assessment of Survival |
6 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed primary malignant glioma, Grade III or IV
- No uncontrolled infection or other active malignancy or chronic systemic immune therapy.
- ECOG performance status three months.
- Adequate labs
Exclusion Criteria
- Diagnosis of genetic disorder of fat metabolism.
- Type 2 diabetes diagnosed with a hemoglobin A1C > 6.4
- Allergic to dairy or lactose intolerance
Data sourced from ClinicalTrials.gov (NCT03278249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.