NCT07501520Completed
Effect of Low Histamine-Based Modified Mediterranean Diet in Multiple Sclerosis
A Randomized Controlled Trial of a Low Histamine-Based Modified Mediterranean Diet in Multiple Sclerosis: The Effect of Dietary Interventions on Clinical Findings, Plasma Histamine, and Oxidative Stress
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 22 Jan 2026
- Start date
- 15 Jun 2024
- Primary completion date
- 10 Mar 2025
- Lead sponsor
- Firat University
- Diseases
- Multiple sclerosis
- NCT number
- NCT07501520
What you commit to
- Study type: Interventional
- Participants enrolled: 51
- From 15 Jun 2024 to the primary completion date, 10 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Relapse and/or corticosteroid treatment within the last 1 month.
- Use of oral anticoagulant therapy.
Other illness
- Clinically significant metabolic, progressive, or malignant disease.
- Insulin-dependent diabetes mellitus.
- Presence of eating disorders, alcohol or substance dependence.
Other
- Use of at least 1 g/day fish oil supplementation.
- Participation in another interventional study.
- Weight loss or gain ≥ 5% in the last 6 months.
- Following a weight-loss diet in the last 2 months.
- Pregnancy or breastfeeding.
- Inability to comply with dietary intervention according to weekly follow-up assessments.
Who the study is looking for
- Age 19 to 64 years.
- Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to 2017 McDonald criteria.
- EDSS score \< 4.5.
- On stable immunomodulatory treatment for at least 6 months.
- Body mass index (BMI) 18.5-24.9 kg/m².
Age in the registry: 19 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Firat University Hospital, Neurology Clinic Coordinator of this site? Confirm its status | Elâzığ | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.