NCT06764563: Mediet4MS

The Effect of a Mediterranean Diet on Quality of Life in Multiple Sclerosis Patients

Recruiting now NA Last updated 25 February 2025

What this trial tests

NA trial testing Mediterranean Medical Nutrition Therapy (counselling) in Multiple Sclerosis in 140 participants. Currently enrolling.

Timeline

1 February 2025

Primary endpoint
1 January 2027

1 January 2028

Quick facts

Lead sponsor	Tel-Aviv Sourasky Medical Center
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	140
Start date	1 February 2025
Primary completion	1 January 2027
Estimated completion	1 January 2028
Sites	1 location across Israel

Drugs / interventions tested

• Mediterranean Medical Nutrition Therapy (counselling)

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Tel-Aviv Sourasky Medical Center

Who can join

Adults 18 to 70, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The role of dietary interventions in improving symptoms of multiple sclerosis (MS) is of high interest amongst patients and researchers, but data supporting this evidence are limited. Current evidence indicates that A higher Expanded Disability Status Scale (EDSS) score correlates with poor diet quality in patients with MS. Moreover, even though disease-modifying therapies (DMT) improve disease course and prognosis, MS patients report a lower quality of life (QoL) than people without illness. The Mediterranean diet (Med-Diet) is beneficial in preventing cardiovascular comorbidities, and outcomes of a decrease in inflammation processes are evident. Recent studies suggest that the Med-Diet might positively affect MS QoL, However, empirical evidence remains unclear, limiting the possibility of evidence-based nutritional recommendations. In the current study, we aim to investigate the effect of the Mediterranean diet on the quality of life of patients with MS.

Methods:

Randomized controlled trial among MS patients aged 18-70. The participants will be randomly assigned to two 1:1 ratio groups: The med-diet group and the control group (no intervention). The intervention will be carried out for six months with subsequent six-months follow-up.

Nine nutrition sessions will be delivered to the intervention group by an expert registered clinical dietitian. Data will be collected at baseline, three months, six months, and 12 months, including the following: Demographic, Anthropometric measurements, Blood tests of complete blood count, chemistry, levels of vitamins D, and B12, CRP, neurofilaments light chain (NfL), Grip strength, Biochemical analysis for fatty acid composition in membranes of red blood cells (RBC) and HPLC analysis of carotenoid concentration. Patients will complete questionnaires for multiple sclerosis quality of life-54 (MSQoL-54), Patient Health Questionnaire (PHQ-9), Fatigue Severity Scale Questionnaire (FSS) and will undergo clinical evaluation for expanded disability status scales (EDSS) and Symbol Digit Modalities Test (SDMT). Dietary analysis and Med-Diet adherence will be validated by the Israeli Mediterranean diet screener (I-MEDAS) and by Food diaries.

Calculated sample size: To achieve a mean difference of 10 points in the MSQoL-54 questionnaire and 80% power, a sample of 77 participants per group is needed. Considering a 5% drop-off, 81 participants per group are needed, and overall, 162 participants.

Expected results: this study will highlight the effect of the Med-Diet dietary pattern on MS quality of life, MS symptoms, and its underlying mechanism, to enable evidence-based nutritional recommendations for MS patients

Importance to Medicine: MS patients suffer from a decrease in QoL. Hence, physicians, researchers, and patients seek nutritional approaches that may improve their condition. If proven beneficial, The Med diet, a dietary approach that has been proven to reduce the risk for major comorbidities and that can be sustained throughout life, has the potential to improve the condition of MS patients in crucial lifestyle aspects.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.