None listed
Conditions
Brief summary
The study hypothesis is that migraines are caused by the constriction of small blood vessels (capillaries) in the brain and that the use of natural, vessel-widening supplements will cause these small blood vessels to dilate and therefore reduce the frequency and severity of migraines. The aim of this study is to investigate whether oral treatment with L-arginine and/or aged garlic extract prevents/decreases migraines in Australian adults. The trial is specifically designed to provide evidence that treatment with these nutraceuticals dilates the small vessels of the brain, thereby improving blood flow and preventing the onset of migraines. This is a double-blind trial, meaning the participant and investigator will not be aware which group the participant has been randomised to. Approximately 240 men and women who have been diagnosed with migraines, will receive 1500 mg/day L-arginine and/or 1000 mg/day aged garlic extract and/or placebo for 14 weeks. Each participant will be required to take 5 capsules a day over the 14 weeks, and will be asked to monitor their migraine frequency and severity. At visit 1, participants will complete a series of daily diaries and questionnaires that will capture information about their pain experience, light-sensitivity and quality of life. We also complete anthropometric measurements. Participants will also receive a 2-week supply of study capsules and two weeks of migraine diaries to be completed daily. At visit 2 (2 weeks after visit 1), participants will provide a blood sample, complete a light-sensitivity test, and an OCTA (optical coherence tomography angiography) scan. Participants will then receive a 12-week supply of the study capsules and migraine diaries to be completed daily. At visit 3 (12 weeks after visit 2), participants will recomplete the questionnaires from visit 1, and will recomplete the measures from visit 2, After the 14 weeks (visits 1-3), we will compare each participant’s baseline (visits 1 & 2) and post-intervention (visit 3) results to examine the impact of L-arginine and aged garlic extract on migraine symptoms, and whether this corresponds with dilation of the small cerebral blood vessels.
Interventions
We compare L-arginine and aged garlic extract (AGE) as separate systemic vasodilating agents to see which (if either) is more effective in preventing migraines. We assess whether any of these comparators have differing efficacies in different aspects of the headache, such as frequency, duration or severity. Each subject will self-administer the treatments as follows: 2500 mg/day placebo as oral capsules for the first 2 weeks, then their allocated treatment (placebo oral capsules, 1500 mg/day L-a
We compare L-arginine and aged garlic extract (AGE) as separate systemic vasodilating agents to see which (if either) is more effective in preventing migraines. We assess whether any of these comparators have differing efficacies in different aspects of the headache, such as frequency, duration or severity. Each subject will self-administer the treatments as follows: 2500 mg/day placebo as oral capsules for the first 2 weeks, then their allocated treatment (placebo oral capsules, 1500 mg/day L-arginine oral capsules, 1000 mg/day AGE oral capsules, or both as oral capsules) for the next 12 weeks. Participants are required to return the initial capsule bottle (placebo capsules provided at week 1) at the baseline visit (week 3). Eighty percent compliance is required to continue in the study to ensure compliance during treatment. Participants are also contacted one week following commencement of treatment to discuss any potential adverse events and treatment compliance. Participants are required to return their treatment capsule bottle(s) at the end of week 14 (post-intervention) visit to monitor adherence.
Sponsors
Curtin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Migraine (with or without aura) diagnosed at least 1 year ago 2. Migraine onset occurred before 50 years of age 3. 2-6 migraine episodes and fewer than 6 'other' headache types per month, over the last 3 months 4. Able to distinguish between migraine and 'other' headache types 5. Able to complete a daily diary about migraine experience 6. Able to commit to taking the 5 capsules a day for 14 weeks
Exclusion criteria
1. Taking medications/drugs affecting vascular tone or blood pressure 2. Taking nitrate drugs or isoproterenol (often prescribed for angina or heart failure) 3. Taking more than two migraine-prevention drugs 4. Taking antidepressants or diuretics, herbs, supplements 5. Taking Sildafenil, Cialis, Spedra and any other PGE-5 inhibitor drugs 6. Taking drugs with potential blood-vessel effects (analgesics, decongestants, or antihistamines) 7. Already taking L-arginine or garlic supplements for 3 months before the study 8. Having headaches causing fainting or another medical emergency 9. Having chronic daily headaches, medication-overuse headaches and/or other secondary headache disorders 10. Having diagnoses other than migraine as the primary cause of headache 11. A change in migraine treatment in the 3 months prior to or during the study 12. Clinical reports of renal or liver dysfunction 13. Clinical risks associated with bleeding or coagulopathy or currently on blood-thinning medications such as warfarin/heparin therapy 14. Having any cardiovascular or neoplastic diseases 15. Having major chronic metabolic or neurologic disorders, or receiving current therapy for them 16. Being diagnosed with psychosis or bipolar affective disorder 17. Diagnosis of cancer 18. Substance abuse/dependence/addiction in the 3 months prior to or during the study 19. Having an history of diabetes, hypertension, collagen vascular disease, vasculitis, or renal disease/failure 20. Having any low-blood-pressure-related issues or Type-1 or -2 diabetes 21. Having the possibility of pregnancy or lactation 22. Being allergic to garlic or its constituents 23. Having gastric disturbances such as bloating, stomach pain, heartburn, diarrhoea, constipation, nausea or vomiting 24. Are a smoker 25. Having an history of eye pathology, surface disorder, surgery (except cataract extraction), injury 26. Not being able to see clearly (with glasses, if need be) 27. Having disorders of the optic nerve (including glaucoma) or retina 28. The significant possibility of our not being able to see the inside of your eye clearly 29. Having poor image perception due to cataract or unstable fixation
Outcome results
None listed