NCT07360405 · American University
Dietary Intervention for Migraine Relief
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
Primary outcome measures
Migraine days
Time frame: 4 weeks
Changes in the number of migraine days with improvement defined as a ≥50% reduction in migraine days
Patient Global Impression of Change
Time frame: 4 weeks
Changes in the patient Global Impression of Change score, where in this study improvement defined as the score of "much" or "very much" improved. This measure is a simple 1-to-7 scale where patients rate how much their condition or symptoms have improved. 1 means very much improved and 7 means very much worse.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Washington D.C., District of Columbia
Collaborators
Georgetown University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 30, 2026 · Source of record for eligibility and locations