[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571068":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":41,"locations":50,"responsibleParty":67,"collaborators":69,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":29,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":29,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":53,"whyStopped":29,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"IRCCS National Neurological Institute \"C. Mondino\" Foundation","OTHER",[8,13,19],{"label":9,"type":6,"description":10,"interventionNames":11},"Mediterranean Diet","The MedDiet will be planned according to the Mediterranean diet pyramid. Energy prescriptions will be tailored to each patient's specific needs. The initial calorie prescription will be calculated taking into account usual dietary intake REE and physical activity level (PAL). Changes to calorie prescriptions will be made as needed during the course of follow-up. A minimum of 0.8-1 g of animal protein (e.g. eggs, milk, meat, poultry and fish) per kilogram of body weight per day will be given.",[12],"Dietary Supplement: Mediterranean Diet",{"label":14,"type":15,"description":16,"interventionNames":17},"Ketogenic Diet","EXPERIMENTAL","Modified Atkins diet with a maximum of 20 g of carbohydrates per day. Fat-rich foods of plant origin will be encouraged in order to reach the prescribed daily caloric intake. Energy prescriptions will be tailored on each patient's specific requirements. The initial calorie prescription will be based on an average between the pre-diet intake, REE and physical activity levels. A minimum of 0.8-1 g of protein from animal sources (e.g. eggs, milk, meat, poultry and fish) per kilogram of body weight per day will be given.",[18],"Dietary Supplement: Ketogenic Diet",{"label":20,"type":6,"description":21,"interventionNames":22},"Control group","The control group will be asked to continue their dietary and lifestyle habits.",[23],"Dietary Supplement: Control group",[25,30,33],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DIETARY_SUPPLEMENT","The MedDiet will be planned according to the Mediterranean diet pyramid",[9],null,{"type":26,"name":14,"description":31,"armGroupLabels":32,"otherNames":29},"Modified Atkins diet with a maximum of 20 g of carbohydrates per day.",[14],{"type":26,"name":20,"description":34,"armGroupLabels":35,"otherNames":29},"The control group will be asked to continue their dietary and lifestyle habits",[20],[37],{"name":38,"affiliation":39,"role":40},"Eleonora Tavazzi, MD","U.O. Sclerosi Multipla","PRINCIPAL_INVESTIGATOR",[42,47],{"name":38,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","0382380385","0039","eleonora.tavazzi@mondino.it",{"name":48,"role":43,"phone":44,"phoneExt":45,"email":49},"Cinzia Fattore, MD","cinzia.fattore@mondino.it",[51],{"facility":52,"status":53,"city":54,"state":29,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"U.O.Sclerosi Multipla","RECRUITING","Pavia","27100","Italy","IT",{"type":59,"coordinates":60},"Point",[61,62],9.15917,45.19205,{"lat":62,"lon":61},[65,66],{"name":38,"role":43,"phone":44,"phoneExt":45,"email":46},{"name":48,"role":43,"phone":44,"phoneExt":45,"email":49},{"type":68,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[70],{"name":71,"class":6},"University of Pavia","100571068","multiple-sclerosis-and-the-effects-of-ketogenic-diet-therapy-100571068",false,"NCT06715436","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","Inclusion Criteria:\n\n* Diagnosis of relapsing-remitting MS (RRMS) or progressive MS (PMS)\n* Age between 18 and 60 years\n* BMI between 18.5 kg\u002Fm2 and 39.9 kg\u002Fm2\n* If on disease-modifying drugs, stable for 6 months, or no use of drugs in the previous 6 months\n* Ability to give verbal and written consent\n\nExclusion Criteria:\n\n* 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)\n* Pregnancy or breastfeeding\n* Relapse or cortisone treatment within 30 days before study entry\n* Clinically relevant metabolic, progressive or malignant diseases\n* Intake of \\> 1 g\u002Fday of omega-3 fatty acid supplements\n* Underweight (BMI\\\u003C18.5 kg\u002Fm2) or severe obesity\n* Significant cognitive-cooperative impairment\n* Insulin-dependent diabetes mellitus (type I)\n* Weight loss greater than 5 kg within 2 months prior to study entry\n* Diagnosis or suspicion of an eating disorder\n* Kidney stones\n* Oral anticoagulant therapy\n* Known alcohol and drug abuse\n\nTelephonic interviews will be performed monthly to evaluate adherence to the dietary treatment and\u002For whether any changes in supplements use, physical activity, nutrition habits.","ALL","18 Years","60 Years",{"count":83,"type":84},111,"ESTIMATED","INTERVENTIONAL",[87],"NA","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\u002FT2 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.",[90],"Multiple Sclerosis, Relapsing-Remitting",[92,93,94],"Multiple Sclerosis","Ketogenic Dietary Therapy","Mediterranean diet","2024-12-18",{"date":97,"type":98},"2024-12-20","ACTUAL",{"date":100,"type":98},"2024-03-15",{"date":102,"type":84},"2025-09-15",{"name":5,"class":6},1]