NCT03451799 is a Phase 1 clinical trial of Ketogenic Diet in GBM, sponsored by Jethro Hu.

Who is sponsoring NCT03451799?

NCT03451799 is sponsored by Jethro Hu.

What drugs are being tested in NCT03451799?

Interventions in NCT03451799: Ketogenic Diet, Standard-of-care radiation, Standard-of-care Temozolomide.

What condition does NCT03451799 study?

NCT03451799 studies GBM, Glioblastoma.

Is NCT03451799 still recruiting?

NCT03451799 is currently completed. Last updated 15 April 2026.

Last reviewed 2026-04-15 · How we verify

NCT03451799

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma

Completed Phase 1 Last updated 15 April 2026

What this trial tests

Phase 1 trial testing Ketogenic Diet in GBM in 21 participants. Completed in 29 April 2024.

Timeline

13 April 2018

Primary endpoint
3 September 2021

29 April 2024

Quick facts

Lead sponsor	Jethro Hu
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	13 April 2018
Primary completion	3 September 2021
Estimated completion	29 April 2024
Sites	1 location across United States

Drugs / interventions tested

Ketogenic Diet — full drug profile →
Standard-of-care radiation
Standard-of-care Temozolomide — full drug profile →

Conditions studied

GBM — all drugs for GBM →
Glioblastoma — all drugs for Glioblastoma →

Sponsor

Jethro Hu — full company profile →

Who can join

18 and older, any sex, with GBM or Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining protocol defined metabolic ketosis. Subjects will be monitored for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
Mitochondria in cancer.
Grasso D, Zampieri LX, Capelôa T, Van de Velde JA, et al · · 2020 · cited 168× · PMID 32548570 · DOI 10.15698/cst2020.06.221
Mechanisms of Resistance and Current Treatment Options for Glioblastoma Multiforme (GBM).
Yalamarty SSK, Filipczak N, Li X, Subhan MA, et al · · 2023 · cited 151× · PMID 37046777 · DOI 10.3390/cancers15072116
Effects of dietary intervention on human diseases: molecular mechanisms and therapeutic potential.
Xiao YL, Gong Y, Qi YJ, Shao ZM, et al · · 2024 · cited 120× · PMID 38462638 · DOI 10.1038/s41392-024-01771-x
From signalling pathways to targeted therapies: unravelling glioblastoma's secrets and harnessing two decades of progress.
Dewdney B, Jenkins MR, Best SA, Freytag S, et al · · 2023 · cited 60× · PMID 37857607 · DOI 10.1038/s41392-023-01637-8
Trial watch: dietary interventions for cancer therapy.
Lévesque S, Pol JG, Ferrere G, Galluzzi L, et al · · 2019 · cited 48× · PMID 31143510 · DOI 10.1080/2162402x.2019.1591878
Immunometabolism: new insights and lessons from antigen-directed cellular immune responses.
Ramalho R, Rao M, Zhang C, Agrati C, et al · · 2020 · cited 39× · PMID 32519148 · DOI 10.1007/s00281-020-00798-w
Science-Driven Nutritional Interventions for the Prevention and Treatment of Cancer.
Montégut L, de Cabo R, Zitvogel L, Kroemer G. · · 2022 · cited 32× · PMID 35997502 · DOI 10.1158/2159-8290.cd-22-0504

Verify or expand the search:

Other trials of Ketogenic Diet

Trials testing the same drug.

NCT07121894 — Ketogenic Intervention for Bipolar Depression · NA · recruiting
NCT06894004 — Mechanism of Ketogenic Diet-Induced Hypercholesterolemia · NA · recruiting
NCT06515912 — Ketogenic Diet in Healthy Adults With Differing BMI · NA · completed
NCT06503809 — Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes · NA · recruiting
NCT06325644 — Well-Formulated Ketogenic Diet Polycystic Kidney Disease · NA · recruiting

Other recruiting trials for GBM

Currently open trials in the same condition.

NCT05902169 — Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM · Phase 3 · active not recruiting
NCT05879367 — Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma · Phase 1 · recruiting
NCT05954858 — Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma · NA · recruiting
NCT05933265 — Study of LP-184 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT06018363 — Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03451799 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jethro Hu
Last refreshed: 15 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03451799.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing