Actively Recruiting
Single-arm, Open-label Trial on the Effects of the Ketogenic Diet in Patients With Brain Tumors and Central Obesity
Led by Meyer Children's Hospital IRCCS · Updated on 2026-02-09
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of the ketogenic diet in children and young adults aged 7 to 30 years who have hypothalamic-chiasmatic tumors. These tumors can disrupt hypothalamic function, leading to central obesity that is difficult to treat with drugs or lifestyle changes. The study aims to see if the ketogenic diet can help reduce excessive weight gain caused by this condition, which is often resistant to conventional treatment. Participants will follow a modified Atkins diet, a type of ketogenic diet chosen for easier adherence. This open-label, single-arm trial monitors patients over 24 months to assess weight loss and metabolic improvements. The diet promotes the use of ketone bodies as an energy source for the brain, which has been effective in other neurological conditions. During the study, researchers will track weight changes, ketosis levels, lipid and carbohydrate parameters, and lean body mass. They will also monitor safety by recording any serious adverse events and adherence rates to the diet. Participants will be followed throughout the 24-month period to evaluate both benefits and risks of this dietary intervention.
CONDITIONS
Brief Title
KETO-TUMOR: a Study on Brain Tumors and Central Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hypothalamic-chiasmatic tumor according to WHO 2021 classification
- Diagnosed with hypothalamic obesity with BMI above the 97th percentile after age 5
- Male or female aged between 7 and 30 years
- Performance status: Lansky score above 40 if under 18 years; Karnofsky score above 40 if 18 to 30 years
- Signed informed consent to participate
- Signed consent by minor patients aged 7 to 17 years
You will not qualify if you...
- Deficiencies in primary carnitine or related enzymes including CPT 2, CACT, beta-oxidation enzymes, MCAD, LCAD, SCAD
- Deficiency in porphyria, pyruvate carboxylase, or long-chain 3-hydroxyacyl-CoA dehydrogenase
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 months
Participants follow the Atkins Modified Diet (MAD) as the dietary intervention.
Trial Site Locations
Total: 1 location
1
Meyer Children's Hospital IRCCS
Florence, Florence, Italy, 50139
Actively Recruiting
Research Team
I
Iacopo Sardi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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