The Effect of a Mediterranean Diet on Quality of Life in Multiple Sclerosis Patients
Recruiting · NCT06764563 · Interventional (participants receive a specific treatment) · Lead sponsor: Tel-Aviv Sourasky Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Confirmed MS based on 2017 Mcdonald criteria, with stable medication regimen in the previous six months.
Exclusion criteria
- Pregnancy or lactating
- People with a lack of judgment
- Serum creatinine ≥2 mg/dL(177 μmol per liter) or more
- Patients who had gastrointestinal problems that would prevent them from following any of the test diets
- Patients who had liver dysfunction (an increase by a factor of at least two above the upper limit of normal in alanine aminotransferase and aspartate aminotransferase levels)
- Active cancer or chemotherapy treatment in the last three years.
Where it is running
1 location listed.
- Tel Aviv Sourasky medical center - Tel Aviv, Israel, Israel