MigraineNCT07360405
Dietary Intervention for Migraine Relief
A study testing Dietary training in people with Migraine, run by American University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine
- What is being tested?
- Dietary training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
American University
Washington D.C., District of Columbia, 20016
Houra Taheri, (202) 885-3810, htaheri@american.edu
About this study
Official title: Diet-Based Treatment for Migraine Relief
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:
Read more
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)
Read the detailed description
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.
- Conditions
- Migraine
- Being tested
- Dietary training
- Keywords
- Migraine, Chronic pain, Diet, Glutamate
- Medical subject headings
- Migraine Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary trainingBehavioural
Also called Low glutamate diet
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 group | Role | What they receive |
|---|---|---|
| Diet group | Active comparator | Not described Receives: Behavioral: Dietary training |
| Control group | No intervention | This group will follow their own diet without any intervention. However after this period, they will given the chance of receiving intervention as well. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine days
Changes in the number of migraine days with improvement defined as a ≥50% reduction in migraine days
Measured: 4 weeks
Patient Global Impression of Change
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.
Measured: 4 weeks
Secondary outcomes (16)
Migraine-specific quality of life
Changes in the quality of life measured by the migraine-specific quality of life. This questionnaire scored 0-100 (higher is better).
Measured: 4 weeks
Migraine duration
Change in migraine duration (hours)
Measured: 4 weeks
Migraine intensity
Change in migraine intensity, measured in scale of 0 (least pain) to 10 (highest pain).
Measured: 4 weeks
Skin carotenoid levels
Change in the skin carotenoid levels (the score is measured by a biophotonic scanner)
Measured: 4 weeks
Skin carotenoid levels
Change in Skin carotenoid levels being measure using a biophotonic scanner
Measured: 4 weeks
Glutathione
Change in the blood levels of glutathione (micromol/L)
Measured: 4 weeks
Coenzyme Q10
Change in the serum level of coenzyme Q10 (mcg/mL)
Measured: 4 weeks
8-hydroxydeoxyguanosine (8OHdG)
Change in the urine levels of 8-hydroxydeoxyguanosine (8OHdG) (mcg/g Creatinine)
Measured: 4 weeks
Lipid peroxides
Change in the urine level of lipid peroxides (micromol/g Creatinine)
Measured: 4 weeks
Glutamate
Change in the plasma levels of glutamate (micromol/dL)
Measured: 4 weeks
Aspartate
Change in the plasma levels of aspartate (micromol/dL)
Measured: 4 weeks
Calcitonin gene-related peptide (CGRP)
Change in the serum calcitonin gene-related peptide (CGRP) level
Measured: 4 weeks
Brain levels of glutamate
Measuring the change in the level of glutamate in brain using Magnetic resonance spectroscopy (MRS)
Measured: 4 weeks
Brain level of glutathione
Measuring the change in the level of glutathione in brain using Magnetic resonance spectroscopy (MRS)
Measured: 4 weeks
Visual cortex thickness
Changes in the visual cortex thickness measured via Magnetic Resonance Imaging (MRI)
Measured: 4 weeks
Blood brain barrier permeability
Change in blood brain barrier permeability will be assessed using magnetic resonance imaging (MRI) with 3-dimensional diffusion-prepared arterial spin labeling (3D DP-ASL), a non-invasive imaging technique for quantifying blood-brain barrier permeability.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-arm design followed by a crossover, double-blind, placebo-controlled challenge with monosodium glutamate (MSG) versus placebo.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgetown University
- Responsible party
- Principal investigator, Kathleen Holton, American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360405
- Sponsor's protocol ID
- IRB-2024-297
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet-Based Treatment for Migraine Relief
- ClinicalTrials.gov ID
- NCT07360405
- Acronym / sponsor ID
- IRB-2024-297
- Conditions
- Migraine
- Keywords
- Migraine, Chronic pain, Diet, Glutamate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- American UniversityUniversity, hospital or other
- Collaborators
- Georgetown University
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-arm design followed by a crossover, double-blind, placebo-controlled challenge with monosodium glutamate (MSG) versus placebo.
| Arm | Type | Receives |
|---|---|---|
| Diet group | Active comparator | Behavioral: Dietary training |
| Control group | No intervention | –This group will follow their own diet without any intervention. However after this period, they will given the chance of receiving intervention as well. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Migraine onset before age 50
- On a stable medication regimen for at least 1 month prior to enrollment
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary trainingAlso: Low glutamate dietSubjects 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. | Behavioural | Diet group |
Primary outcome
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.
16 secondary outcomes
Migraine-specific quality of life
Time frame: 4 weeks
Migraine duration
Time frame: 4 weeks
Migraine intensity
Time frame: 4 weeks
Skin carotenoid levels
Time frame: 4 weeks
Skin carotenoid levels
Time frame: 4 weeks
Glutathione
Time frame: 4 weeks
Coenzyme Q10
Time frame: 4 weeks
8-hydroxydeoxyguanosine (8OHdG)
Time frame: 4 weeks
Lipid peroxides
Time frame: 4 weeks
Glutamate
Time frame: 4 weeks
Aspartate
Time frame: 4 weeks
Calcitonin gene-related peptide (CGRP)
Time frame: 4 weeks
Brain levels of glutamate
Time frame: 4 weeks
Brain level of glutathione
Time frame: 4 weeks
Visual cortex thickness
Time frame: 4 weeks
Blood brain barrier permeability
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary training in people with Migraine, run by American University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Holton (5037571578, holton@american.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine days (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.