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
Abstract
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.
Primary outcome: Change in fatigue severity (Fatigue Severity Scale [FSS]; scale range: 9-63; higher scores indicate greater fatigue).
Enrollment: 51 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 51 participants or records.
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