Dietary Intervention for Migraine Relief

Официальное название

Diet-Based Treatment for Migraine Relief

Обзор

The goal of this clinical trial is to evaluate whether a low-glutamate diet can improve migraine symptoms in adults with migraine and to explore possible biological changes associated with dietary improvement. The study focuses on whether reducing dietary glutamate intake may influence processes involved in migraine, such as brain excitation, inflammation, and oxidative stress. The main questions this study aims to answer are: Does following a low-glutamate diet reduce the number of migraine days and the severity and duration of migraine attacks, and improve quality of life? Are improvements in migraine symptoms associated with changes in blood-based biological markers related to migraine activity? Researchers will compare participants assigned to the low-glutamate diet with participants assigned to a wait-list control group to evaluate differences in migraine outcomes and related biological measures. Participants will: Complete a baseline run-in period while tracking headaches using a daily migraine diary Either follow a low-glutamate dietary intervention or continue their usual diet as part of a wait-list control Complete standardized questionnaires related to migraine symptoms and quality of life Provide blood samples for laboratory analyses Undergo neuroimaging assessments (for a subset of participants)

Подробное описание

The purpose of this clinical trial is to evaluate whether a low-glutamate diet is an effective treatment for migraine and to explore how this dietary approach may influence biological processes related to migraine. The low-glutamate diet reduces intake of free glutamate commonly found in ultra-processed foods and food additives, while emphasizing whole foods rich in nutrients that support brain health and reduce oxidative stress.

The study is based on prior research showing that this diet led to substantial improvements in migraine symptoms among individuals with chronic pain, with migraine remission often observed after one month. These improvements were also associated with measurable changes in brain structure, suggesting a potential link between dietary glutamate exposure and migraine-related brain changes.

The primary goals of this study are to:

Determine whether one month on a low-glutamate diet reduces migraine frequency, severity, and duration and improves quality of life

Examine changes in blood markers related to migraine pain signaling

Assess whether dietary changes are associated with changes in brain structure or chemistry in a subset of participants

Participants will first complete a 4-week run-in period during which they will continue their usual diet and record headaches and migraines using a daily electronic diary. Eligible participants will then be randomly assigned to either begin the low-glutamate diet immediately or continue their usual diet for one additional month (wait-list control). All participants will complete questionnaires, provide blood and urine samples, and undergo in-person assessments at the end of each study phase. A subset of participants will also undergo Magnetic Resonance Imaging (MRI) scans.

Participants assigned to the diet will receive structured dietary training, educational materials, and weekly follow-up support to promote adherence. After the initial dietary phase, participants will complete a double-blind, placebo-controlled crossover challenge, during which they will receive short courses of monosodium glutamate (MSG) and placebo while remaining on the low-glutamate diet. This phase is designed to determine whether migraine symptoms return specifically in response to glutamate exposure.

Throughout the study, participants will continue to track migraine symptoms using daily diaries. The results of this study may help determine whether a low-glutamate diet is a safe, non-pharmacologic treatment option for migraine and may provide insight into dietary factors that contribute to migraine development and persistence.

Вмешательства

• Поведенческое Dietary training
  Subjects will undergo a 2-hour online training session to teach them how to follow the low glutamate diet. The low glutamate diet is a healthy, whole-food diet designed to limit the intake of free glutamate/aspartate, while also emphasizing the consumption of foods which are high in nutrients that protect against glutamate excitotoxicity and oxidative stress.

Первичные конечные точки

• Migraine days [Срок оценки: 4 weeks]
• Patient Global Impression of Change [Срок оценки: 4 weeks]

Вторичные конечные точки (12)

• Migraine-specific quality of life [Срок оценки: 4 weeks]
• Migraine duration [Срок оценки: 4 weeks]
• Migraine intensity [Срок оценки: 4 weeks]
• Skin carotenoid levels [Срок оценки: 4 weeks]
• Skin carotenoid levels [Срок оценки: 4 weeks]
• Glutathione [Срок оценки: 4 weeks]
• Coenzyme Q10 [Срок оценки: 4 weeks]
• 8-hydroxydeoxyguanosine (8OHdG) [Срок оценки: 4 weeks]
• Lipid peroxides [Срок оценки: 4 weeks]
• Glutamate [Срок оценки: 4 weeks]
• Aspartate [Срок оценки: 4 weeks]
• Calcitonin gene-related peptide (CGRP) [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• Men and women of all races and ethnicities
• Age 18-75 years
• Documented diagnosis of chronic or episodic migraine for at least 6 months, based on International Classification of Headache Disorders, 3rd edition (ICHD-III) criteria, defined as:

• 8 headache days per month, and
• 4 migraine days per month
• Migraine onset before age 50
• On a stable medication regimen for at least 1 month prior to enrollment
• Willing to maintain stable medications throughout the study
• Willing to discontinue supplements during the study period
• Women of childbearing potential must be willing to use birth control during the study timeframe

Критерии исключения

• Current pregnancy, plans to become pregnant during the study timeframe, or current breastfeeding
• Current use of medications affecting glutamatergic or gamma-Aminobutyric Acid (GABA) neurotransmission (unless discontinued under physician guidance)
• Current use of quarterly injectable migraine preventive medications
• Unwillingness to modify dietary intake or to stop alcohol and marijuana use during the study
• Substance use disorder within the past year
• Diagnosed seizure disorder
• Severe asthma requiring past hospitalization

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• American University — Washington D.C.

Идентификаторы

NCT: NCT07360405 · IRB-2024-297

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗