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Effect of Low Histamine-Based Modified Mediterranean Diet in Multiple Sclerosis

NCT07501520 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-07-31

No results posted yet for this study

Summary

This randomized controlled trial will evaluate the effects of a low histamine-based modified Mediterranean diet in adults with relapsing-remitting multiple sclerosis (RRMS). The study will compare three groups: a low-histamine modified Mediterranean diet, a traditional Mediterranean diet, and a control group without dietary intervention. The main outcomes include clinical measures such as disability status, fatigue, migraine, gastrointestinal symptoms, and quality of life, as well as blood markers including plasma histamine, diamine oxidase activity, total antioxidant capacity, and oxidative stress indicators. The goal is to determine whether reducing dietary histamine within a Mediterranean diet pattern provides additional benefits beyond a traditional Mediterranean diet in improving symptoms and biological markers related to inflammation and oxidative stress in RRMS.

Conditions

  • Multiple Sclerosis (MS) - Relapsing-remitting
  • Mediterranean Diet

Interventions

BEHAVIORAL

Low Histamine-Based Modified Mediterranean Diet

Structured dietary program based on the Mediterranean diet with restriction of high-histamine and histamine-releasing foods (e.g., aged cheeses, processed meats, certain fish, fermented products, vinegar, some fruits and vegetables.

BEHAVIORAL

Traditional Mediterranean Diet

Structured dietary program following a traditional Mediterranean diet rich in vegetables, fruits, whole grains, legumes, olive oil, and fish, without specific histamine-related restrictions.

Sponsors & Collaborators

  • The Scientific and Technological Research Council of Turkey

    collaborator OTHER

  • Firat University

    lead OTHER

Principal Investigators

  • Murat Gönen, Prof. Dr. · Firat University Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2025-03-10
Completion
2025-06-10

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07501520 on ClinicalTrials.gov