Effects of Ketogenic Diet on Multiple Sclerosis

The Effects of Ketogenic Diet Therapy Versus the Mediterranean Diet on Quality of Life in a Group of Patients With Multiple Sclerosis - the KETOMED-MS Study

This study is testing whether a ketogenic diet or a Mediterranean diet can help people with relapsing-remitting multiple sclerosis feel better and manage their symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 111 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation (other)
• Locations: 1 site (Pavia)
• Trial ID: NCT06715436 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 60 with a diagnosis of relapsing-remitting multiple sclerosis who are stable on disease-modifying drugs or not using them.

Not a fit: Patients actively engaged in weight loss programs or those with significant cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer dietary interventions as a new strategy to manage multiple sclerosis and improve patient outcomes.

How similar studies have performed: Previous studies have suggested dietary patterns, particularly the Mediterranean diet, may lower the risk of developing MS, indicating potential success for this dietary approach.

Eligibility criteria

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 this trial is running

Pavia

• U.O.Sclerosi Multipla — Pavia, Italy (RECRUITING)

Study contacts

• Principal investigator: Eleonora Tavazzi, MD — U.O. Sclerosi Multipla
• Study coordinator: Eleonora Tavazzi, MD

Conditions: Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Ketogenic Dietary Therapy, Mediterranean diet