Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma
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ClinicalTrials.gov Identifier: NCT03278249 |
Recruitment Status :
Active, not recruiting
First Posted : September 11, 2017
Last Update Posted : November 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioblastoma | Other: Modified Atkins Ketogenic Diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma |
Actual Study Start Date : | October 12, 2017 |
Estimated Primary Completion Date : | December 1, 2021 |
Estimated Study Completion Date : | January 1, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Modified Atkins Ketogenic Diet
Modified Atkins Ketogenic Diet in combination with Temodar and Radiation
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Other: Modified Atkins Ketogenic Diet
Less than 20 grams of carbohydrates per day |
- Assessment of inducing ketosis [ Time Frame: 6 weeks ]Ketosis measured by serum beta-hydroxybuterate
- Assessment of progression free survival [ Time Frame: 6 months ]
- Assessment of survival [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 < 3.
- Life expectancy > 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278249
United States, Ohio | |
UC Health | |
Cincinnati, Ohio, United States, 45219 |
Principal Investigator: | Rekha Chaudhary, MD | University of Cincinnati |
Responsible Party: | Rekha Chaudhary, Associate Professor of Medicine, University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT03278249 |
Other Study ID Numbers: |
UCCI-BRAIN-16-01 |
First Posted: | September 11, 2017 Key Record Dates |
Last Update Posted: | November 24, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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