What this study is
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)
What's being tested
- Dietary training
Intervention · BEHAVIORAL
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.
Study details
- Official title
- Diet-Based Treatment for Migraine Relief
- Sponsor
- American University
- Conditions
- Migraine
- Enrolling
- 40 people
- Starts
- 2026-03-02
- Est. completion
- 2027-05
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openAmerican University
Washington D.C., District of Columbia, United States
- Houra Taheri · Contact(202) 885-3810htaheri@american.edu
Recruiting
Study team
Sponsor
American University
Study ID IRB-2024-297
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.