Effect of Low Histamine-Based Modified Mediterranean Diet in Multiple Sclerosis (NCT07501520) | Clinical Trial Compass
CompletedNot Applicable
Effect of Low Histamine-Based Modified Mediterranean Diet in Multiple Sclerosis
Turkey (Türkiye)51 participantsStarted 2024-03-15
Plain-language 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.
Who can participate
Age range
19 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.