Dietary Intervention for Migraine Relief

NCT07360405 | Not Yet Recruiting

• 1 other identifier: IRB-2024-297
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Conditions

Migraine

Keywords

Migraine; Chronic pain; Diet; Glutamate

Outcome Measures

Primary Outcomes (2)

• Migraine days

  Changes in the number of migraine days with improvement defined as a ≥50% reduction in migraine days

  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.

  4 weeks

Secondary Outcomes (16)

• Migraine-specific quality of life

  4 weeks

• Migraine duration

  4 weeks

• Migraine intensity

  4 weeks

• Skin carotenoid levels

  4 weeks

• Skin carotenoid levels

  4 weeks

Study Arms (2)

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.

Interventions

Dietary training 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.

Also known as: Low glutamate diet

Diet group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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:
• headache days per month, and
• 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 may not qualify 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

Sponsors & Collaborators

• American University: lead
• Georgetown University: collaborator

Study Sites (1)

American University

Washington D.C., District of Columbia, 20016, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kathleen Holton

CONTACT

5037571578; holton@american.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible in this trial as the nature of intervention is diet based.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel-arm design followed by a crossover, double-blind, placebo-controlled challenge with monosodium glutamate (MSG) versus placebo.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 22, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)