RecruitingNot ApplicableNCT06715436

Multiple Sclerosis and the Effects of Ketogenic Diet Therapy

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


Sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Enrollment

111 participants

Start Date

Mar 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a ketogenic diet (a very low-carbohydrate, high-fat diet) can help manage multiple sclerosis (MS) symptoms and slow progression of the disease. Participants will follow a dietary plan and be monitored over time. **You may be eligible if...** - You have relapsing-remitting MS (RRMS) or progressive MS (PMS) - You are between 18 and 60 years old - Your BMI is between 18.5 and 39.9 - If on MS medication, your dose has been stable for at least 6 months - You are willing and able to follow the assigned diet **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had an MS relapse or steroid treatment in the past 30 days - You have insulin-dependent (type 1) diabetes - You have kidney stones or take blood thinners - You have an eating disorder - You are underweight or severely obese - You are currently on another specific diet or weight-loss program - You abuse alcohol or drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTMediterranean Diet

The MedDiet will be planned according to the Mediterranean diet pyramid

DIETARY_SUPPLEMENTKetogenic Diet

Modified Atkins diet with a maximum of 20 g of carbohydrates per day.

DIETARY_SUPPLEMENTControl group

The control group will be asked to continue their dietary and lifestyle habits


Locations(1)

U.O.Sclerosi Multipla

Pavia, Italy

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NCT06715436


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