Effects of Ketogenic Diet on Multiple Sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of ketogenic dietary therapy and the Mediterranean diet on patients with relapsing-remitting multiple sclerosis (MS). It aims to explore how these dietary patterns may influence neuroinflammation and disease progression in MS patients. Participants will be assigned to either a ketogenic diet, a Mediterranean diet, or a control group, and their health outcomes will be monitored over time. The study seeks to provide insights into the role of diet as a potential therapeutic approach for managing MS symptoms and progression.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of relapsing-remitting MS (RRMS) or progressive MS (PMS)
* Age between 18 and 60 years
* BMI between 18.5 kg/m2 and 39.9 kg/m2
* If on disease-modifying drugs, stable for 6 months, or no use of drugs in the previous 6 months
* Ability to give verbal and written consent

Exclusion Criteria:

* Patients actively engaged in a weight loss program or other specific diet (e.g. vegetarian, vegan); patients not willing to follow the assigned dietary pattern or patients with high adherence to MedDiet (MediLite score \> 14)
* Pregnancy or breastfeeding
* Relapse or cortisone treatment within 30 days before study entry
* Clinically relevant metabolic, progressive or malignant diseases
* Intake of \> 1 g/day of omega-3 fatty acid supplements
* Underweight (BMI\<18.5 kg/m2) or severe obesity
* Significant cognitive-cooperative impairment
* Insulin-dependent diabetes mellitus (type I)
* Weight loss greater than 5 kg within 2 months prior to study entry
* Diagnosis or suspicion of an eating disorder
* Kidney stones
* Oral anticoagulant therapy
* Known alcohol and drug abuse

Telephonic interviews will be performed monthly to evaluate adherence to the dietary treatment and/or whether any changes in supplements use, physical activity, nutrition habits.

Where it's running

• U.O.Sclerosi Multipla
  Pavia, Italy Recruiting

Study contacts

• Principal investigator: Eleonora Tavazzi, MD — U.O. Sclerosi Multipla
• Study coordinator: Eleonora Tavazzi, MD
• Email: eleonora.tavazzi@mondino.it
• Phone: 0382380385

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.