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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Confirmed MS based on 2017 Mcdonald criteria, with stable medication regimen in the previous six months.

Locations
Other Locations
Israel
Tel Aviv Sourasky medical center
RECRUITING
Tel Aviv
Contact Information
Primary
Arnon Karni, MD
arnonk@tlvmc.gov.il
+972-52-426-6733
Backup
Hadas Hardoon, PhD candidate
aradhardoon1@mail.tau.ac.il
+972-52-356-2580
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 140
Treatments
Experimental: Intervention- Mediterranean diet nutritional counselling
No_intervention: control, no dietary change
Participants in the non-dietary intervention group will continue their usual diet
Related Therapeutic Areas
Sponsors
Leads: Tel-Aviv Sourasky Medical Center
Collaborators: Ariel University

This content was sourced from clinicaltrials.gov