Recruiting

Low-Glutamate Diet

Sponsor:

American University

Code:

NCT07360405

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dietary training

Study Details

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

Study ID

NCT07360405

Start date

Mar 2, 2026

Status verified date

Oct, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Diet group

no intervention: Control group

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

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 measure

  • Migraine days [ Time Frame: 4 weeks ]
  • Patient Global Impression of Change [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Kathleen Holton

5037571578holton@american.edu

Locations

American University

Recruiting

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

Contacts

Houra Taheri

(202) 885-3810htaheri@american.edu

More Information

Sponsor

American University

Last update posted

Oct 30, 2026

Last verified

Oct, 2026

Keywords

  • Migraine
  • Chronic pain
  • Diet
  • Glutamate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by American University on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.