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Multiple Sclerosis and the Effects of Ketogenic Diet Therapy

RecruitingNAAges 18 Years - 60 YearsAllIRCCS National Neurological Institute "C. Mondino…
NCT06715436 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Multiple sclerosis (MS) is an inflammatory and immune-mediated neurological disease with multifactorial etiology. The specific etiopathogenetic mechanisms of MS are still unknown but it is clear that it results from a combination of genetic and environmental factors. Several studies have reported the possible role of diet as a risk factor for MS and its progression. To date, many dietary patterns and their association with MS have been studied, but data is still limited and inconclusive. Mediterranean Diet (MedDiet) has been associated with a lower risk of developing MS, compared to a Western-style diet. In one of investigators' studies, higher MedDiet adherence was associated with a 6-fold greater likelihood of having lower disease severity than those with low adherence. A significant restriction of carbohydrates (up to ketogenesis) can have beneficial effects on various parameters (inf

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📋 Eligibility rules (as published)
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.
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What it tests

  • Mediterranean Diet
  • Ketogenic Diet
  • Control group
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Where

1 site
U.O.Sclerosi Multipla
Pavia, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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