Multiple Sclerosis and the Effects of Ketogenic Diet Therapy
Recruiting · NCT06715436 · Interventional (participants receive a specific treatment) · Lead sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 (inflammatory markers, oxidative stress, altered glucose metabolism) which are altered in subjects with MS. Ketogenic diet therapies (KDTs) have been recommended mainly for children with drug-resistant epilepsy, but in recent years they have been applied to Multiple Sclerosis. Preclinical studies in animal models evaluating the efficacy of KDTs in experimental autoimmune encephalomyelitis (EAE) found a beneficial effect of diet in slowing of disease progression, improvement of motor disability, reduction of inflammatory cytokines and reactive oxygen species. In a randomized study, improvements in health-related quality of life (HRQL) scores and a slight decrease in EDSS scores were found. An open-label, single-arm study of 20 patients with RRMS also reported that, after 6 months of MAD, no subjects had new or enlarging FLAIR/T2 lesions, with a significant improvement in the EDSS score, the Modified Fatigue Impact Scale subscales and arm. A 3-arm parallel-arm randomized controlled pilot study was planned to determine the effectiveness of a modified Atkins diet (MAD) compared to a Mediterranean diet (MedDiet) on quality of life in a population with MS.
Who can take part
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 is running
1 location listed.
- U.O.Sclerosi Multipla - Pavia, Italy