Diet-Based Treatment for Migraine Relief
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
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)
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking is not possible in this trial as the nature of intervention is diet based.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Kathleen Holton
Professor
American University