Dietary Intervention for Migraine

Overseen By Kathleen Holton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: American University

Must not be taking: Glutamatergic, GABA, Injectable migraine

Disqualifiers: Pregnancy, Seizure disorder, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a low-glutamate diet can reduce migraine days and improve the severity and duration of migraine attacks. Researchers aim to determine if reducing glutamate, found in many foods, affects brain excitation, inflammation levels, and oxidative stress—all factors in migraines. Participants will either follow this special diet or maintain their usual eating habits for comparison. The study seeks individuals who have experienced migraines for at least six months and have at least four migraine days each month. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to new dietary approaches for managing migraines.

Will I have to stop taking my current medications?

You can continue taking your current medications as long as they have been stable for at least a month before joining the study. However, you must stop taking any supplements during the study.

What prior data suggests that this dietary intervention is safe for migraine patients?

In a previous study, more than half of Gulf War veterans experienced migraines before starting a low-glutamate diet. After just one month on the diet, the number of veterans with migraines fell to less than 20%. This suggests that the diet might help reduce migraines. Another study found no adverse reactions or side effects, indicating that the diet is easy to follow. Overall, these findings suggest that a low-glutamate diet could be a safe way to manage migraines without medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional migraine treatments that often rely on medications like triptans or beta-blockers, the low-glutamate diet offers a dietary approach to managing migraines. Most current treatments aim to alleviate symptoms or prevent migraines through pharmaceuticals, but this diet focuses on potentially reducing migraine frequency by limiting glutamate intake, an excitatory neurotransmitter. Researchers are excited about this because it offers a non-drug alternative that could benefit those who either cannot tolerate medications or prefer a more natural approach. Plus, dietary interventions have the potential to improve overall health, making this an appealing option for many individuals.

What evidence suggests that a low-glutamate diet might be an effective treatment for migraine?

Research has shown that eating less glutamate can help reduce migraine symptoms. In one study, participants experienced a decrease in symptoms from 21 to 14 after just one month on this diet. Another study found that more than half of the participants with migraines felt better, with their migraine frequency dropping to less than 20%. Additionally, this diet has been linked to changes in the brain that might aid in migraine relief. These findings suggest that reducing glutamate intake could be a promising way to manage migraines. Participants in this trial will follow a low-glutamate diet to assess its effectiveness in reducing migraine symptoms. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who suffer from migraines, with at least 8 headache days and 4 migraine days per month. Participants must have had migraines start before age 50, be on stable medications for a month prior to the study, and agree to stop taking supplements. Women able to have children should use birth control during the study.

Inclusion Criteria

Willing to maintain stable medications throughout the study

Willing to discontinue supplements during the study period

My gender or ethnicity does not limit my eligibility.

Exclusion Criteria

Current pregnancy, plans to become pregnant during the study timeframe, or current breastfeeding

I am not currently taking medications for nerve signaling unless advised by my doctor.

I am currently using injectable medications every three months to prevent migraines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Baseline Run-in

Participants complete a baseline run-in period while tracking headaches using a daily migraine diary

4 weeks

Daily diary entries

Dietary Intervention

Participants follow a low-glutamate dietary intervention or continue their usual diet as part of a wait-list control

4 weeks

Weekly follow-up support

Crossover Challenge

Participants complete a double-blind, placebo-controlled crossover challenge with MSG and placebo

Short courses

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

In-person assessments

What Are the Treatments Tested in This Trial?

Interventions

• Low-Glutamate Diet

Trial Overview

The trial tests if a low-glutamate diet can lessen migraine symptoms compared to those not changing their diet (wait-list control). It will check if this diet reduces migraine frequency, severity, duration and improves life quality by tracking changes in biological markers related to migraines.

How Is the Trial Designed?

Group I: Diet group Active Control 1 Intervention

Group II: Control group Active Control 1 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 Is Running the Clinical Trial?

American University

Lead Sponsor

Trials

22

Recruited

5,600+

Georgetown University

Collaborator

Trials

355

Recruited

142,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07360405

NCT07360405 | Dietary Intervention 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 ...

2.

cdn.nutrition.org

cdn.nutrition.org/article/S2475-2991(24)01135-1/fulltext

The Low Glutamate Diet Improves Headache and Other ...

Results: After one month on the diet, the mean (SD) of total symptom number reduced from 21 (7) to 14 (6), p=0.001, and symptom severity also significantly ...

3.

medicine.georgetown.edu

medicine.georgetown.edu/news-releases/low-glutamate-diet-linked-to-brain-changes-and-migraine-relief-in-veterans-with-gulf-war-illness/

Low-Glutamate Diet Linked to Brain Changes and Migraine ...

“More than half of the Gulf War veterans had migraines before the diet, and that dropped to under 20% after following the diet for one month,” ...

4.

migrainecollaborative.org

migrainecollaborative.org/low-glutamate-diet-as-a-potential-therapy-for-headache-in-veterans-with-gulf-war-illness-preliminary-clinical-trial-results

Low glutamate diet as a potential therapy for headache in ...

Outcome measures included a ≥30% and ≥50% reduction in headache days, attack duration, intensity, and a severity × duration score (headache ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7551234/

The Low Glutamate Diet Effectively Improves Pain and Other ...

These results suggest that the low glutamate diet can effectively reduce overall symptoms, pain and fatigue in GWI.

6.

cdn.nutrition.org

cdn.nutrition.org/article/S2475-2991(24)01135-1/pdf

The Low Glutamate Diet Improves Headache and ...

No adverse events related to the supplement were reported in this study, indicating good safety and tolerability. Together, these results indicate SUP.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11478386/

The Evidence for Diet as a Treatment in Migraine—A Review

The main finding of this review is that a few studies have shown that KD, DASH diet, low-fat vegan diet, and GFsD may decrease migraine ...