About this trial
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)
Eligibility criteria
Qualifiers
Men and women of all races and ethnicities
Age 18-75 years
8 headache days per month, and
4 migraine days per month
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dietary training
Treatment groups
Sponsors and collaborators
American University
Lead sponsor
Georgetown University
Collaborator