The KetoGlioma (Ketogenic Glioma) Study
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|ClinicalTrials.gov Identifier: NCT05373381|
Recruitment Status : Not yet recruiting
First Posted : May 13, 2022
Last Update Posted : December 9, 2022
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Dietary Supplement: Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt||Not Applicable|
This study is designed to analyze the feasibility of using the sHFLC + KetoPhyt as an anti-cancer agent against glioblastoma multiforme (GBM). While the classic ketogenic diet typically uses a 4:1 ratio of fat to proteins/carbohydrates, the sHFLC + KetoPhyt diet has a maximum 2:1 ratio. This allows increased flexibility in the diet and improved nutritional sufficiency. Preclinical and controlled patient data supports that the sHFLC + KetoPhyt diet is able to decrease blood glucose levels while increasing circulating ketones, two key effects of the ketogenic diet. As caloric restriction is not used in this approach, the investigators hypothesize that patients will be able to have an increased dietary compliance compared to those patients on the very restrictive ketogenic diet, but still achieve a ketotic state.
There is general consensus in the field that the use of the phyto anti-inflammatory diet and exogenous ketone supplementation can all lead to ketosis in a matter of days, and not become what is referred to as ketone adaptative for many weeks to months. Ketosis, with blood levels of the ketone body beta-hydroxy- butarate >0.5 mM, undergoes an adaptive process where different tissues at different times alter the biochemistry of their cellular fuel sources following the switching from a glucose- to fat- and lipid-metabolism. This affects the ability to precisely measure different states of ketosis in the study population over time as the adaptive processes are temporally unique, however previous studies have described the "…adaptation periods necessary… for particular tissue ketone oxidation following sustained nutritional ketosis…" , and these investigators even related this to inflammation-associated cytokine expressions as the investigators propose to measure in this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Modified Ketogenic, Anti-Inflammatory Diet for Patients With High-Grade Gliomas|
|Estimated Study Start Date :||February 1, 2023|
|Estimated Primary Completion Date :||August 31, 2023|
|Estimated Study Completion Date :||November 30, 2023|
Experimental: Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt
Subjects will adhere to the sHFLC + KetoPhyt diet for six 4-week cycles.
Dietary Supplement: Supplemental High Fat Low Carbohydrate (sHFLC) + KetoPhyt
Following a screening period, subjects will adhere to the sHFLC + KetoPhyt diet for six 4-week cycles. Patients will receive dietary advice from a Registered Dietitian (RD) to allow for the design of 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].
- Number of participants not able to adhere the sHFLC + KetoPhyt Diet [ Time Frame: From Cycle 1 Day 1 to end of Cycle 6 (Each cycle is 28 days) ]
Patients' ability to adhere to the sHFLC + KetoPhyt Diet as defined by the presence of the following:
- >75% compliance with taking supplement 2x/day throughout the study period
- >75% of days with carbohydrate intake <33%
- Change from baseline between the patient's glucose and ketone levels at 24 weeks as assessed by the Glucose/Ketone Index (GKI) [ Time Frame: Measured daily from Cycle 1 Day 1 to end of Cycle 6 (Each cycle is 28 days) ]Blood glucose and ketone levels measured at the same time once per day from baseline to 24 weeks via a glucose/ketone monitor and test strips. The Glucose/Ketone Index will be used to monitor patient's glucose and ketone levels.
- Change from baseline in pro-inflammatory markers and exosome biomarkers at 24 weeks [ Time Frame: At Cycle 1 Day 1 and at Cycle 6 Day 1 (Each cycle is 28 days) ]Comparison of the numbers of EGFrVIII+ exosomes and exosomal microRNAs in each participant's blood measured at baseline (Cycle 1 Day 1) and 24 weeks (Cycle 6).
- Change from baseline between the patient's gut microbiome at 24 weeks as assessed by 16s ribosomal sequences. [ Time Frame: Measured daily from Cycle 1 Day 1 to end of Cycle 6 (Each cycle is 28 days) ]DNA purified from stool samples (16s ribosomal sequences) will be compared at baseline and 24 weeks.
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): NCT05373381
|Contact: Latoya Lashley, MPHemail@example.com|
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Contact: Latoya Lashley, MPH 617-636-3264 firstname.lastname@example.org|
|Principal Investigator: Suriya Jeyapalan, MD|