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Ketogenic diet therapy for chronic migraines

Evaluating the safety, tolerability and efficacy of the ketogenic diet therapy in adults with chronic migraines

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000784516
Enrollment
25
Registered
2024-06-26
Start date
2024-12-01
Completion date
2025-08-01
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is a prospective single-group cohort study to evaluate the safety and tolerability of a modified ketogenic diet as an adjunct preventative treatment in adults with chronic migraine.

Interventions

Study participants will undergo a 12-week trial of a modified ketogenic diet (MKD) for the prevention of chronic migraine. Participants will undergo a 5-week baseline/screening period, and then under the supervision of an expert dietitian, transition to a MKD for 12 weeks. The diet will contain a ratio of 75% fat, 20% protein and 5% carbohydrates, however calorie quantities will be tailored to each participant. Participants will receive initial counselling and resources (roughly 1 hour duratio

Study participants will undergo a 12-week trial of a modified ketogenic diet (MKD) for the prevention of chronic migraine. Participants will undergo a 5-week baseline/screening period, and then under the supervision of an expert dietitian, transition to a MKD for 12 weeks. The diet will contain a ratio of 75% fat, 20% protein and 5% carbohydrates, however calorie quantities will be tailored to each participant. Participants will receive initial counselling and resources (roughly 1 hour duration for initial consultation), and regular review with the study dietitian (roughly 30 minute duration for subsequent visits on monthly basis). Initial consultation will be face-to-face to ensure anthropometrics and baseline blood tests can be collected. Subsequent visits can be face-to-face, telehealth or telephone reviews based on patient preference. Study activities will include daily urinary ketone monitoring, and two-weeks of continuous glucose monitoring (CGM) while on therapy, in addition to standard of care blood safety monitoring. Adherence will be monitored with a food diary and urinary ketones. The continuous glucose monitoring will occur during weeks 1-2 of the study (prior to starting ketogenic diet) and also weeks 17-18 of the study (weeks 11 and 12 of the diet). The study resources provided are used in clinical practice and clinical trials involving the ketogenic diet at our centre. They have been designed by Dr Neha Kaul, Senior Dietitian. The materials have been reviewed and approved by consumers and by the institution’s human research ethics committee.

Sponsors

Alfred Health
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

- Aged 18-60 at time of enrolment - At least a 1-year history of migraine, and current diagnosis of chronic migraine for three months (The International Classification of Headache Disorders 3 (ICHD-3 criteria) - No change in migraine treatment in the preceding three months prior to enrolment

Exclusion criteria

- Body mass index less then 18.5kg/m2 - Fatty acid or amino acid oxidation disorder - Pre-existing renal and/or liver failure - Known diagnosis of diabetes mellitus - History of pancreatitis - HbA1c greater then or equal to 6% - Prior history of eating disorder that the treating clinician or dietitian reasonably considers may be exacerbated by dietary therapy - Women who are pregnant, breastfeeding or planning to become pregnant during the study - Allergy to medical adhesives - Unable to participate in study visits.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026