Glioblastoma therapy with Serine- and Glycine-free diet (B-FREE) Trial

Glioblastoma therapy with Serine- and Glycine-free diet (B-FREE) Trial - B-FREE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038325

Enrollment

Registered

2026-01-30

Start date

2026-02-28

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma and malignant Glioma

Interventions

Group 1: A total of 20 evaluable patients are to be enrolled in the study. Eligible participants are those with imaging findings suggestive of a malignant glioma or a recurrence of a previously diagno

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - suspicion of glioma WHO grade II, III or IV as assessed by cerebral imaging (MRI) - interdisciplinary recommendation for resection or biopsy - Karnofsky performance status >= 60, ECOG 100000/µl, leukocytes > 3000/µl

Exclusion criteria

Exclusion criteria: - severe diarrhea, vomiting, malabsorption syndrome, bowel obstruction, subileus or active gastrointestinal bleeding. - insulin-dependent diabetes - uncontrolled thyroid function - pancreatic insufficiency - decompensated heart failure (NYHA > 2) - myocardial infarction within the last 6 months, symptomatic atrial fibrillation - severe acute infection or clinically relevant immunosuppression (HIV infection, granulocytopenia 4mg/day - major contraindications to MRI scanning (e.g. presence of implanted MRI-incompatible cardiac devices) - participate in other intervention clinical trials (including drugs, nutritional supplements, medical devices, etc.) within the last 3 months - allergy to sample components - use of other nutritional supplements that may affect the effectiveness of the study - Patients with cognitive impairments or mental illnesses that are unable to comprehend the research content - Patients with insufficcient proficiency in German language to provide informed consent or participate in study procedures

Design outcomes

Primary

Measure	Time frame
Primary Outcome: Assessment of metabolic and immunological changes induced by the serine- and glycine-free diet. Timing of parameter assessments? Blood and urine (metabolic and immunologic parameters): Day 0 (baseline), Day 5, and Day 10. Includes complete and differential blood count, immunophenotyping (e.g., T cells, B cells, NK cells), electrolytes, glucose/HbA1c, liver and kidney function parameters, lipids, total protein/albumin, coagulation profile, TSH, insulin/IGF-1, amino acids, and extended lipidomic and metabolomic analyses. MR spectroscopy: Day 0 and Day 10, performed on a 7-Tesla MR scanner. Cerebrospinal fluid (optional): Day 0 and Day 10. Analysis of metabolic and immunologic markers, including lipidome/metabolome profiling, cfDNA analyses, and cellular fraction characterization. Tumor tissue (metabolomic and immunologic parameters): Postoperatively (after biopsy/resection). Includes standard neuropathological workup and extended metabolic and immunologic analyses; results will be compared with a matched biobank control cohort (patients without dietary intervention). Data collection methods Biosampling and laboratory analyses: Venous blood and urine samples are collected on Day 0, Day 5, and Day 10; parameters as listed above (including amino acid profiling). Cerebrospinal fluid (optional) is collected on Day 0 and Day 10 for extended molecular analyses, including lipidome/metabolome profiling, cfDNA next-generation sequencing (NGS), low-pass whole genome sequencing (WGS), methylation profiling, and analysis of the cellular fraction. Tumor tissue is analyzed by standard neuropathological procedures (immunohistochemistry, IDH mutation, MGMT promoter methylation, sequencing/methylation profiling) and by additional metabolic, immunologic, and -omics analyses. Results are compared to a matched control cohort from the UCT Biobank (patients without dietary intervention). Imaging (MRS/MRSI): 7-Tesla MRI/MRSI with SLASER sequence (optimized echo time	—

Measure

Time frame

Primary Outcome: Assessment of metabolic and immunological changes induced by the serine- and glycine-free diet. Timing of parameter assessments? Blood and urine (metabolic and immunologic parameters): Day 0 (baseline), Day 5, and Day 10. Includes complete and differential blood count, immunophenotyping (e.g., T cells, B cells, NK cells), electrolytes, glucose/HbA1c, liver and kidney function parameters, lipids, total protein/albumin, coagulation profile, TSH, insulin/IGF-1, amino acids, and extended lipidomic and metabolomic analyses. MR spectroscopy: Day 0 and Day 10, performed on a 7-Tesla MR scanner. Cerebrospinal fluid (optional): Day 0 and Day 10. Analysis of metabolic and immunologic markers, including lipidome/metabolome profiling, cfDNA analyses, and cellular fraction characterization. Tumor tissue (metabolomic and immunologic parameters): Postoperatively (after biopsy/resection). Includes standard neuropathological workup and extended metabolic and immunologic analyses; results will be compared with a matched biobank control cohort (patients without dietary intervention). Data collection methods Biosampling and laboratory analyses: Venous blood and urine samples are collected on Day 0, Day 5, and Day 10; parameters as listed above (including amino acid profiling). Cerebrospinal fluid (optional) is collected on Day 0 and Day 10 for extended molecular analyses, including lipidome/metabolome profiling, cfDNA next-generation sequencing (NGS), low-pass whole genome sequencing (WGS), methylation profiling, and analysis of the cellular fraction. Tumor tissue is analyzed by standard neuropathological procedures (immunohistochemistry, IDH mutation, MGMT promoter methylation, sequencing/methylation profiling) and by additional metabolic, immunologic, and -omics analyses. Results are compared to a matched control cohort from the UCT Biobank (patients without dietary intervention). Imaging (MRS/MRSI): 7-Tesla MRI/MRSI with SLASER sequence (optimized echo time

—

Secondary

Measure	Time frame
Secondary endpoints: Changes in quality of life (assessed using EORTC QLQ-C30 and EORTC QLQ-BN20 on day 0 and day 10) Adherence to and subjective tolerability of the diet (questionnaires and dietary diary) Changes in the gut microbiome (stool sample analysis before and after the diet) Correlation between systemic and tumor-associated metabolic alterations Optimization and validation of MR spectroscopic parameters (e.g., serine/glycine signals)	—

Measure

Time frame

Secondary endpoints: Changes in quality of life (assessed using EORTC QLQ-C30 and EORTC QLQ-BN20 on day 0 and day 10) Adherence to and subjective tolerability of the diet (questionnaires and dietary diary) Changes in the gut microbiome (stool sample analysis before and after the diet) Correlation between systemic and tumor-associated metabolic alterations Optimization and validation of MR spectroscopic parameters (e.g., serine/glycine signals)

—

Countries

Germany

Contacts

Public ContactAnna-Luisa Luger

Universitätsklinikum Frankfurt, Klinik für Neurologie, Dr. Senckenbergisches Institut für Neuroonkologie

anna-luisa.luger@unimedizin-ffm.de+49 69-6301 95095

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026