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Calorie Restriction in Multiple Sclerosis

Active Not RecruitingNA

Sponsor: Federico II University

Conditions: Multiple Sclerosis, Relapsing-Remitting, Caloric Restriction

Interventions: Caloric restriction, Caloric restriction without cow's milk and gluten

Countries: Italy

There is a strong relationship between metabolic state and immune tolerance through a direct control exerted on immune cells by specific intracellular nutrient-energy sensors. An increased "metabolic work load" represents a novel issue linking metabolism with loss of self-immune tolerance. Several disease-modifying drugs have been approved for Relapsing-remitting Multiple Sclerosis (RR-MS) treatments and have shown to reduce relapse rates by modulating immune responses; however, their impact on long-term disease progression and accrual of irreversible neurological disability remains largely unclear, underlining the need for novel therapeutic strategies. In this context, both acute fasting (AF) and chronic caloric restriction (CR) have been shown to improve experimental autoimmune encephalomyelitis (EAE). Despite this evidence, no specific studies have been performed to dissect at the cellular level the mechanism of action of CR in the context of autoimmunity and MS. This study aims at investigating this specific point in order to pave the way for a wider utilization of a nutritional approach to alter MS progression and activity. The aim of this study is to improve the outcome of RR-MS and the efficacy of first line drug treatments (ie. Copaxone or Tecfidera) by altering the metabolic state of the host via calorie restriction with the aim to re-equilibrate immune/inflammatory responses of patients.

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Subjects with early diagnosis (no more than 2 years) of RR-MS according to the revised McDonald (2017) criteria;
* Subjects naïve-to-treatment;
* Subjects with EDSS between 0-5.5;
* No use of oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 30 days prior to screening visit;
* Subjects with BMI \> 22 kg/m2 and BMI \< 28 kg/m2;
* Willing to collect a food diary for one week and to donate a blood and stool samples;
* No antibiotic treatment within 3 months of enrolment;
* No immunosuppressive therapy;
* Signed informed consent.

Exclusion Criteria:

* Pregnancy and breast-feeding;
* History of alcohol or drug abuse;
* Serious psychiatric disorders;
* Any major medical problem that in the opinion of the investigator could bias the results (e.g. HIV infection) or affect adherence to the protocol;
* Subjects with inadequate haematological function (defined by leukocyte ≤ 2,0 x 109; platelets \<100 x 109; haemoglobin \<12 g/dl for female and \<13 g/dl for male), liver function (defined by aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase \> 2.0 times upper limit of normal), thyroid function (according to physician's discretion);
* Known hypersensitivity to gadolinium;
* Any other condition that would prevent the subject from undergoing a contrast-enhanced MRI scan;
* Any contra-indication according to the specific first line treatment for MS.

Locations (1)

Pozzilli, IS, Italy