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Calorie Restriction in Multiple Sclerosis
Sponsor: Federico II University
Summary
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.
Official title: Calorie Restriction as a Novel Therapeutic Tool to Manipulate Immunity and Improve Therapeutic Potential of First Line Drug Treatments During Relapsing Remitting Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
93
Start Date
2020-07-14
Completion Date
2025-09
Last Updated
2024-08-20
Healthy Volunteers
No
Interventions
Caloric restriction
Patients will be treated with a diet regimen of mild caloric restriction (15-20% caloric restriction)
Caloric restriction without cow's milk and gluten
Patients will be treated with mild caloric restriction (15-20% caloric restriction) plus excluding from diet cow's milk, its derivatives and gluten.
Locations (1)
Neuromed - Istituto Neurologico Mediterraneo Pozzilli
Pozzilli, IS, Italy