Calorie Restriction in Multiple Sclerosis (NCT04042415) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Calorie Restriction in Multiple Sclerosis
Italy93 participantsStarted 2020-07-14
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of the "no evident disease activity" (NEDA) from baseline clinical status of MS patients at 6, 12, and 24 months
Timeframe: T0: before intervention, T1: after 6 months of intervention, T2: after 12 months of intervention, T3: after 24 months of intervention