Ketogenic (modified Atkins) diet for hypothalamic tumor–related central obesity
Single-arm, Open-label, Single-center, Non-profit Interventional Clinical Trial on the Effects of the Ketogenic Diet in Patients With Brain Tumors and Central Obesity
This trial will try a modified Atkins ketogenic diet to help children and young adults with hypothalamic-chiasmatic tumors lose excess weight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 7 Years to 30 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Florence, Florence) |
| Trial ID | NCT07396896 on ClinicalTrials.gov |
What this trial studies
This interventional, single-center protocol enrolls patients aged 7–30 who have hypothalamic-chiasmatic tumors and severe hypothalamic obesity that is refractory to medical therapy. Participants will follow a modified Atkins ketogenic diet with regular clinical monitoring, metabolic laboratory testing, and safety checks, and individuals with inherited fatty-acid oxidation or related metabolic enzyme deficiencies are excluded. The research is conducted at Meyer Children's Hospital IRCCS in Florence and requires informed consent from patients and guardians for minors. Primary outcomes will focus on changes in weight/BMI and metabolic/endocrine markers, along with measures of tolerability and adherence.
Who should consider this trial
Good fit: Children and young adults aged 7–30 with a confirmed hypothalamic-chiasmatic tumor, BMI above the 97th percentile (after age 5), and adequate performance status who can follow a ketogenic diet are ideal candidates.
Not a fit: Patients with inherited fatty-acid oxidation or related metabolic disorders, those unable to adhere to a ketogenic eating plan, or whose obesity is not driven by hypothalamic injury are unlikely to benefit.
Why it matters
Potential benefit: If successful, the diet could reduce excessive weight and improve metabolic health and quality of life for patients with hypothalamic obesity.
How similar studies have performed: Ketogenic diets are well established for pediatric drug-resistant epilepsy, but their specific use for hypothalamic obesity is novel and supported mainly by small case series and limited pilot data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of hypothalamic-chiasmatic tumour according to the WHO 2021 classification 2. Diagnosis of hypothalamic obesity: after 5 years of age, BMI \>97th percentile in the WHO 2007 curves 3. Males and females aged between 7 and 30 years 4. Performance status: Lansky score \> 40 for patients aged \< 18 years and Karnofsky score \> 40 for patients aged between 18 and 30 years 5. Signature of informed consent to participate in the study 6. Signature of consent by the minor patient to participate in the study (7-13 years and 14-17 years). Exclusion Criteria: 1\. Deficiencies of: * Primary carnitine * Carnitine palmitoyltransferase 2 (CPT 2) * Carnitine acylcarnitine translocase (CACT) * Beta-oxidation * Medium-chain acyl-CoA dehydrogenase (MCAD) * long-chain acyl-CoA dehydrogenase (LCAD) * short-chain acyl-CoA dehydrogenase (SCAD) * porphyria * pyruvate carboxylase * long-chain 3-hydroxyacyl-CoA dehydrogenase.
Where this trial is running
Florence, Florence
- Meyer Children's Hospital IRCCS — Florence, Florence, Italy (Recruiting)
Study contacts
- Study coordinator: Iacopo Sardi
- Email: iacopo.sardi@meyer.it
- Phone: 0555662631
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.