Glioma Modified Atkins-based Diet in Patients With Glioblastoma

NCT02286167 | Completed DMC

• 2 other identifiers: IRB00037347CCCWFU 99116
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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

Glioblastoma Multiforme

Keywords

modified-Atkins diet; ketogenic diet; central nervous system malignancy; glioma

Outcome Measures

Primary Outcomes (1)

• 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

  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

  8 weeks per patient

Secondary Outcomes (3)

• Biologic activity measured by pre- and post-study cerebral glutamate and glutamine concentrations assessed by MRS.

  8 weeks per patient

• Tolerability assessed by percent of patients who have an adverse reaction of any grade attributed to the diet of possible, probable, or definite

  8 weeks per patient

• Dietary Activity

  8 weeks per patient

Study Arms (1)

Single arm diet

OTHER

Intermittent, modified Atkins diet

Other: Diet modification

Interventions

Diet modification OTHER

All patients will be participate in the intermittent, modified Atkins diet

Single arm diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Karnofsky performance status \>/= 60.
• Patients must be at least 18 years of age.

You may not qualify if:

• 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.
• 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.
• Severe acute infection.
• BMI \> 35.0 or BMI \< 20.0.
• Active bowel obstruction, ileus, or active or remote pancreatitis.
• Clinically significant heart failure (NYHA \>2), recent myocardial infarction, or symptomatic atrial fibrillation.
• Clinically significant renal disease (creatinine \>2.0 mg/dL, urea \>100 mg/dL).
• Clinically significant hepatic dysfunction (alanine or aspartate aminotransferase \>7 times the upper limit of normal).
• Patients with insulin-dependent diabetes mellitus.
• Conditions that may increase the risk of the diet or significantly reduce compliance (i.e. cognitive impairment, frank dementia, etc).
• Other concurrent experimental therapies.
• Milk allergy.
• Treatment with the modified Atkins diet (MAD) for any cause within the 9 months prior to study enrollment
• Patient inability to complete baseline screening 3-day diet record.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: collaborator

Study Sites (2)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Schreck 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 DERIVED

MeSH Terms

Conditions

Glioblastoma; Glioma

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Roy E. Strowd, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Jaishri O. Blakeley, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 7, 2014
• Study Start: November 1, 2014
• Primary Completion: January 3, 2019
• Study Completion: July 12, 2019
• Last Updated: March 24, 2026

Record last verified: 2019-08

Locations

US (2)