Glioma Modified Atkins-based Diet in Patients With Glioblastoma (GLAD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02286167|
Recruitment Status : Active, not recruiting
First Posted : November 7, 2014
Last Update Posted : July 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Other: Diet modification||Not Applicable|
Malignant gliomas have a high glycolytic rate and are dependent on glucose for energy metabolism. This so called "Warburg effect" or the reliance of central nervous system (CNS) tumor cells on glucose utilization through glycolysis has been identified as a potential therapeutic target in cancer metabolism. Preclinically, reduced cerebral glucose via calorie restriction has been repeatedly associated with tumor reduction and improved survival in glioma animal models. Such work has led to several early clinical studies evaluating the ketogenic diet (KD) in patients with recurrent GBM.
The modified Atkins diet (MAD) is designed to provide a more palatable, less restrictive but effective alternative to the strict KD, particularly for adults. The MAD does not require inpatient admission for initial fast, weight of foods, or severe dietary restrictions and is generally well tolerated, easier to administer, and more practical for adults. The MAD lacks calorie restriction, an important component to dietary therapies in preclinical investigations. Emerging evidence also suggests that short term fasting may provide superior anti-cancer activity to long term calorie restriction and that these benefits have been observed without substantial weight loss that can be observed with longer term calorie restriction.
In glioma patients, a diet therapy that combines the broad clinical application of the MAD with the caloric impact of short-term intermittent fasting is therefore optimal. Moreover, initiation of this diet when the cancer has already undergone induction therapy and is clinically and radiographically stable, may provide the optimal time for metabolic intervention to prevent recurrence or progression.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Feasibility and Biologic Effect of a Modified Atkins-based Intermittent Fasting Diet in Patients With Glioblastoma (GBM)|
|Actual Study Start Date :||November 2014|
|Actual Primary Completion Date :||January 3, 2019|
|Estimated Study Completion Date :||July 2019|
Single arm diet
Intermittent, modified Atkins diet
Other: Diet modification
All patients will be participate in the intermittent, modified Atkins diet
- 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 [ Time Frame: 8 weeks per patient ]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
- Biologic activity measured by pre- and post-study cerebral glutamate and glutamine concentrations assessed by MRS. [ Time Frame: 8 weeks per patient ]Measured by pre- and post-study cerebral glutamate and glutamine concentrations assessed by MRS.
- Tolerability assessed by percent of patients who have an adverse reaction of any grade attributed to the diet of possible, probable, or definite [ Time Frame: 8 weeks per patient ]Percent of patients who have an adverse reaction of any grade attributed to the diet of possible, probable, or definite
- Dietary Activity [ Time Frame: 8 weeks per patient ]Dietary compliance will be assessed by serial changes in serum glucose, ketones, weight trajectory, body fat composition, change in seizure frequency without AED adjustment
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): NCT02286167
|United States, Maryland|
|The Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|United States, North Carolina|
|Wake Forest School of Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Roy E. Strowd, MD||Wake Forest University Health Sciences|
|Principal Investigator:||Jaishri O. Blakeley, MD||Johns Hopkins University|