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

NCT06764563 | Recruiting

• 1 other identifier: TLV-0621-23
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; mediterranean diet; quality of life

Outcome Measures

Primary Outcomes (1)

• MS QOL score

  As measured in MSQOL-54 questionnaire. score range 0-100. Higher score mean a better outcome.

  six months

Secondary Outcomes (6)

• Disease Disability score

  six months

• Chronic fatigue levels

  Six months

• Depression levels

  six months

• Carotenoid plasma concentration.

  six months

• Neurofilament light chain (NfL).

  six months

Other Outcomes (14)

• Vitamin B12

  six months

• Body Mass Index (BMI)

  six months

• Muscle strength

  six months

Study Arms (2)

Intervention- Mediterranean diet nutritional counselling

EXPERIMENTAL

Behavioral: Mediterranean Medical Nutrition Therapy (counselling)

control, no dietary change

NO INTERVENTION

Participants in the non-dietary intervention group will continue their usual diet

Interventions

Mediterranean Medical Nutrition Therapy (counselling) BEHAVIORAL

The participants in the intervention group will receive dietary guidance on the Mediterranean diet during 9 sessions over six months. The sessions which will be held in groups of ten individuals. In-person group sessions will be held three times: at the first meeting, after three months, and after six months. During the remaining six sessions, 6 online video sessions (by the institutional telemedicine program) will be delivered and include 60 minutes of nutritional educational sessions with a registered dietitian once a month

Intervention- Mediterranean diet nutritional counselling

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Ariel University: collaborator

Study Sites (1)

Tel Aviv Sourasky medical center

Tel Aviv, Israel, 6423906, Israel

RECRUITING

Related Publications (8)

• Ghasemi N, Razavi S, Nikzad E. Multiple Sclerosis: Pathogenesis, Symptoms, Diagnoses and Cell-Based Therapy. Cell J. 2017 Apr-Jun;19(1):1-10. doi: 10.22074/cellj.2016.4867. Epub 2016 Dec 21.

  PMID: 28367411 BACKGROUND

• Swank RL, Dugan BB. Effect of low saturated fat diet in early and late cases of multiple sclerosis. Lancet. 1990 Jul 7;336(8706):37-9. doi: 10.1016/0140-6736(90)91533-g.

  PMID: 1973220 BACKGROUND

• Yu M, Jelinek G, Simpson-Yap S, Neate S, Nag N. Self-reported ongoing adherence to diet is associated with lower depression, fatigue, and disability, in people with multiple sclerosis. Front Nutr. 2023 Mar 1;10:979380. doi: 10.3389/fnut.2023.979380. eCollection 2023.

  PMID: 36937366 BACKGROUND

• Shai I, Spence JD, Schwarzfuchs D, Henkin Y, Parraga G, Rudich A, Fenster A, Mallett C, Liel-Cohen N, Tirosh A, Bolotin A, Thiery J, Fiedler GM, Bluher M, Stumvoll M, Stampfer MJ; DIRECT Group. Dietary intervention to reverse carotid atherosclerosis. Circulation. 2010 Mar 16;121(10):1200-8. doi: 10.1161/CIRCULATIONAHA.109.879254. Epub 2010 Mar 1.

  PMID: 20194883 BACKGROUND

• Mousavi-Shirazi-Fard Z, Mazloom Z, Izadi S, Fararouei M. The effects of modified anti-inflammatory diet on fatigue, quality of life, and inflammatory biomarkers in relapsing-remitting multiple sclerosis patients: a randomized clinical trial. Int J Neurosci. 2021 Jul;131(7):657-665. doi: 10.1080/00207454.2020.1750398. Epub 2020 Apr 16.

  PMID: 32249637 BACKGROUND

• Moravejolahkami AR, Paknahad Z, Chitsaz A. Association of dietary patterns with systemic inflammation, quality of life, disease severity, relapse rate, severity of fatigue and anthropometric measurements in MS patients. Nutr Neurosci. 2020 Dec;23(12):920-930. doi: 10.1080/1028415X.2019.1580831. Epub 2019 Mar 21.

  PMID: 30896320 BACKGROUND

• Evans E, Levasseur V, Cross AH, Piccio L. An overview of the current state of evidence for the role of specific diets in multiple sclerosis. Mult Scler Relat Disord. 2019 Nov;36:101393. doi: 10.1016/j.msard.2019.101393. Epub 2019 Sep 9.

  PMID: 31574403 BACKGROUND

• Katz Sand I, Benn EKT, Fabian M, Fitzgerald KC, Digga E, Deshpande R, Miller A, Gallo S, Arab L. Randomized-controlled trial of a modified Mediterranean dietary program for multiple sclerosis: A pilot study. Mult Scler Relat Disord. 2019 Nov;36:101403. doi: 10.1016/j.msard.2019.101403. Epub 2019 Sep 24.

  PMID: 31610401 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Counseling

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Vered Kaufman-Shriqui, PhD

  Ariel University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnon Karni, MD

CONTACT

+972-52-426-6733; arnonk@tlvmc.gov.il

Hadas Hardoon, PhD candidate

CONTACT

+972-52-356-2580; aradhardoon1@mail.tau.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Block randomize assignment to two study groups: intervention and control.

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 25, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)