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

Plain English Summary

Effect of Low Histamine-Based Modified Mediterranean Diet in Multiple Sclerosis is a Not Applicable clinical trial sponsored by Firat University studying Multiple Sclerosis (MS) - Relapsing-remitting, Mediterranean Diet. This study tests if a special Mediterranean diet, lower in histamine, can help manage symptoms in people with a common type of Multiple Sclerosis (MS). It is for adults diagnosed with relapsing-remitting MS who are between 19 and 64 years old. Participants will follow one of three diets: a low-histamine Mediterranean diet, a regular Mediterranean diet, or no specific diet change, and will be monitored for 12 weeks. Alternatives include standard medical treatments for MS and other dietary approaches, but this study focuses on a specific histamine-modified diet. The trial aims to enroll 51 participants.

Official 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

Here is what you need to know about eligibility for this trial. You can join if you are between 19 and 64 years old and have been diagnosed with relapsing-remitting MS. You must have a mild disability score (EDSS less than 4.5) and have been on stable MS medication for at least 6 months. A healthy weight (BMI between 18.5-24.9) is also required. You cannot join if you've had an MS relapse or used steroids recently, have other serious health conditions, are pregnant or breastfeeding, or are taking certain supplements or medications. This trial is studying Multiple Sclerosis (MS) - Relapsing-remitting, Mediterranean Diet, so participants generally need a confirmed diagnosis.

What They're Measuring

The study will measure changes in fatigue, disability, and quality of life to see if the special diet makes a difference in how patients feel and function. The specific primary outcome measures are: Change in fatigue severity (Fatigue Severity Scale [FSS]; scale range: 9-63; higher scores indicate greater fatigue) (From baseline to 12 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it explores a new dietary approach to potentially reduce inflammation and improve symptoms in Multiple Sclerosis, addressing a gap in current treatment options. This research targets Multiple Sclerosis (MS) - Relapsing-remitting, Mediterranean Diet, where improved treatment options are needed.

Investor Insight

This study investigates a specific dietary intervention for a chronic condition, potentially opening new avenues for symptom management and indicating a growing interest in lifestyle factors for MS tr

Is This Trial Right for Me?

Ask your doctor if this diet is appropriate for your MS and overall health. Be prepared to follow a specific diet plan for 12 weeks and attend regular check-ups. Understand that you will be assigned to one of three diet groups randomly. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 51 participants

Interventions

• BEHAVIORAL: Low Histamine-Based Modified Mediterranean Diet — Structured dietary program based on the Mediterranean diet with restriction of high-histamine and histamine-releasing foods (e.g., aged cheeses, processed meats, certain fish, fermented products, vinegar, some fruits and vegetables.
• BEHAVIORAL: Traditional Mediterranean Diet — Structured dietary program following a traditional Mediterranean diet rich in vegetables, fruits, whole grains, legumes, olive oil, and fish, without specific histamine-related restrictions.

Primary Outcomes

• Change in fatigue severity (Fatigue Severity Scale [FSS]; scale range: 9-63; higher scores indicate greater fatigue) (From baseline to 12 weeks)

Secondary Outcomes

• Change in disability status (Expanded Disability Status Scale [EDSS]; scale range: 0-10; higher scores indicate greater disability) (From baseline to 12 weeks)
• Change 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)
• 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)

Full 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.

Trial Locations

• Firat University Hospital, Neurology Clinic, Elâzığ, Elâzığ, Turkey (Türkiye)

Frequently Asked Questions

Related Conditions

• Multiple Sclerosis (MS)
• Relapsing-Remitting MS
• Neurological Disorders
• Autoimmune Diseases
• Inflammatory Conditions
• Dietary Interventions
• Mediterranean Diet
• Histamine Intolerance
• Oxidative Stress
• Chronic Fatigue

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