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

CompletedNA

Sponsor: Firat University

Conditions: Multiple Sclerosis (MS) - Relapsing-remitting, Mediterranean Diet

Interventions: Low Histamine-Based Modified Mediterranean Diet, Traditional Mediterranean Diet

Countries: Turkey (Türkiye)

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.

Eligibility overview

Sex: ALL

Age: 19 Years to 64 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Relapse and/or corticosteroid treatment within the last 1 month.
* Clinically significant metabolic, progressive, or malignant disease.
* Use of at least 1 g/day fish oil supplementation.
* Insulin-dependent diabetes mellitus.
* 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.
* Use of oral anticoagulant therapy.
* Presence of eating disorders, alcohol or substance dependence.
* Pregnancy or breastfeeding.
* Inability to comply with dietary intervention according to weekly follow-up assessments.

Locations (1)

Elâzığ, Elâzığ, Turkey (Türkiye)