Health TrialsbyHealthPanel

Dietary Intervention for Migraine Relief

ConditionMigraine
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAmerican University

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Diet groupActive comparator 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Migraine days

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

Time frame
4 weeks
2

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.

Time frame
4 weeks

Secondary outcomes

1

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).

Time frame
4 weeks
2

Migraine duration

Change in migraine duration (hours)

Time frame
4 weeks
3

Migraine intensity

Change in migraine intensity, measured in scale of 0 (least pain) to 10 (highest pain).

Time frame
4 weeks
4

Skin carotenoid levels

Change in the skin carotenoid levels (the score is measured by a biophotonic scanner)

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

American University

Lead sponsor

Georgetown University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: