Effect of Low Histamine-Based Modified Mediterranean Diet in Multiple
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
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 19 months ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Low Histamine-Based Modified Mediterranean Diet
Compared with
- Traditional Mediterranean Diet
What it measured
Main measures
Change in fatigue severity (Fatigue Severity Scale [FSS]; scale range: 9-63; higher scores indicate greater fatigue)
From baseline to 12 weeks
Fatigue
Other measures (6)
Change in disability status (Expanded Disability Status Scale [EDSS]; scale range: 0-10; higher scores indicate greater disability)
From baseline to 12 weeks
Disability progressionChange in health-related quality of life (36-Item Short Form Survey [SF-36]; scale range: 0-100 per domain; higher scores indicate better health-related quality of life)
From baseline to 12 weeks
Quality of life (reported by participants)Change in serum total antioxidant capacity
From baseline to 12 weeks
Change in oxidative stress markers (e.g., malondialdehyde)
From baseline to 12 weeks
Change in plasma histamine levels
From baseline to 12 weeks
Change in diamine oxidase (DAO) activity
From baseline to 12 weeks
Who could take part
Relapsing MS · 19 to 64
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Jun 2024
Main results due
Mar 2025
Finished
Jun 2025