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Could a High-Fat diet help brain tumor patients lose weight?

NCT ID NCT07396896

Disease control Sponsor: Meyer Children's Hospital IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a modified Atkins diet (a type of ketogenic diet) can help children and young adults with brain tumors lose weight. The tumors often damage the hypothalamus, leading to severe obesity that doesn't respond to standard diets or exercise. Researchers will enroll 30 participants aged 7 to 30 and track weight loss over 24 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Modified Atkins Diet (a type of ketogenic diet)
What this could lead to
If it works, this could offer a practical, drug-free way to manage severe obesity in young brain tumor survivors, improving their long-term health.
What could go wrong
This is a small, early-stage study with no control group, so results may not apply to everyone. The diet is hard to stick to, and side effects or lack of weight loss are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 to 30 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hypothalamic neoplasm obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypothalamic neoplasms Obese patients

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Meyer Children's Hospital IRCCS

    RECRUITING

    Florence, Florence, 50139, Italy

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