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ketogenic diet

Phase 1

Glioblastoma Multiforme | Unknown | Oncology |Atlantic International Corp.|Last Updated: Nov 9, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

ketogenic diet · 1 trial · 1 indication

Phase 1 1
NCT01865162Ketogenic Diet as Adjunctive Treatment in Refractory/End-stage Glioblastoma Multiforme: a Pilot StudyGlioblastoma Multiforme
COMPLETED6 Analytics
PHASE1COMPLETED
Ketogenic Diet as Adjunctive Treatment in Refractory/End-stage Glioblastoma Multiforme: a Pilot Study
Glioblastoma MultiformeUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety of ketogenic diet as adjunctive treatment of treatment-refractory glioblastoma multiforme.
one year

Early treatment discontinuation, treatment compliance, 7-point Licker hunger scale, fasting lipid levels and fasting serum glucose and insulin levels

Secondary Endpoints

To obtain pilot data on efficacy of ketogenic diet as adjunctive treatment of treatment-refractory glioblastoma multiforme
one year
To evaluate tolerability of ketogenic diet as adjunctive treatment of treatment-refractory glioblastoma multiforme.
one year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ketogenic dietEXPERIMENTALTreatment will consist of ketogenic diet. KD will consist of 4:1 \[fat\] : \[protein+carbohydrate\] weight ratio with 1600 kcal restriction. The diet will be supplemented with vitamins, calcium, phosphorus, zinc and selenium supplements to meet the requirements of US Dietary Reference Intakes (DRI) standard.

Interventions

NameTypeDescription
ketogenic dietOTHERTreatment will consist of ketogenic diet. KD will consist of 4:1 \[fat\] : \[protein+carbohydrate\] weight ratio with 1600 kcal restriction. The diet will be supplemented with vitamins, calcium, phosphorus, zinc and selenium supplements to meet the requirements of US Dietary Reference Intakes (DRI) standard.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age 18-65 2. Ability and willingness to signed informed consent form. 3. Astrocytoma grade 4 (glioblastoma multiforme, GBM, histologically confirmed, WHO criteria) 4. Documented recurrence or progression after surgical resection/debulking, radiation and temozolamide chemother...

Countries:United States
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Frequently asked questions about ketogenic diet

What is Ketogenic Diet, Standardized Diet used for in Glioblastoma Multiforme?

Ketogenic Diet, Standardized Diet is an investigational dietary intervention being studied as an adjunctive treatment for Glioblastoma Multiforme, a type of brain cancer. It is being evaluated in clinical trials to assess its potential role alongside standard therapies such as radiation and chemotherapy for this condition.

Who is developing Ketogenic Diet, Standardized Diet?

Ketogenic Diet, Standardized Diet is being developed by Atlantic International Corp., a company traded under the ticker symbol ATLN. The company is conducting clinical research to evaluate this dietary approach in the context of glioblastoma multiforme treatment.

What phase is Ketogenic Diet, Standardized Diet in?

Ketogenic Diet, Standardized Diet is currently in Phase 2 clinical development for glioblastoma multiforme. It remains an investigational dietary intervention and has not been approved by regulatory authorities. Its clinical program includes completed trials that have evaluated its safety and feasibility.

What clinical trials is Ketogenic Diet, Standardized Diet in?

Ketogenic Diet, Standardized Diet has been studied in two completed clinical trials. NCT01865162 was a Phase 1 pilot study in refractory or end-stage glioblastoma multiforme with 6 participants. NCT02302235 was a Phase 2 pilot study testing the diet as an adjunct to radiation and chemotherapy in glioblastoma multiforme, enrolling 42 participants.

Is Ketogenic Diet, Standardized Diet the same as a standard ketogenic diet?

Ketogenic Diet, Standardized Diet refers to a specific standardized formulation of a ketogenic diet being investigated as a therapeutic intervention. It is distinct from general dietary recommendations, as it is being developed and studied in a controlled clinical setting for its potential effects on glioblastoma multiforme.