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ACTIVE NOT RECRUITING
NCT04042415
NA

Calorie Restriction in Multiple Sclerosis

Sponsor: Federico II University

View on ClinicalTrials.gov

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

OTHER

Caloric restriction

Patients will be treated with a diet regimen of mild caloric restriction (15-20% caloric restriction)

OTHER

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