None listed
Conditions
Brief summary
This study will test whether a nutritional supplement approach can help reduce migraines in adults who experience frequent episodic migraines. Participants will take either a semi-essential amino acid alone or a semi-essential amino acid with a vascular-active, anti-inflammatory nutraceutical formulation, with neither the participants nor researchers knowing which treatment is given until the study ends. We hypothesise that the combination of a semi-essential amino acid with a vascular-active, anti-inflammatory nutraceutical formulation will be more effective at preventing migraines than semi-essential amino acid alone. Primary outcomes include migraine-related quality of life and pain severity. Secondary outcomes include biomarkers of vascular tone regulation (nitrite, ADMA, endothelin-1) and an unexpected-effects questionnaire.
Interventions
A phase-II, randomised, double-blind, two-arm, 16-week study will be conducted in individuals with migraines. This study aims to evaluate the effects of a semi-essential amino acid alone or in combination with a vascular-active, anti-inflammatory nutraceutical on migraine associated pain and quality of life. Each participant will be randomised into the 2 arms and self-administer the allocated nutraceuticals.
Arm 1: Semi-essential amino acid + placebo
Arm 2: Semi-essential amino acid + Vascula
A phase-II, randomised, double-blind, two-arm, 16-week study will be conducted in individuals with migraines. This study aims to evaluate the effects of a semi-essential amino acid alone or in combination with a vascular-active, anti-inflammatory nutraceutical on migraine associated pain and quality of life. Each participant will be randomised into the 2 arms and self-administer the allocated nutraceuticals. Arm 1: Semi-essential amino acid + placebo Arm 2: Semi-essential amino acid + Vascular-active, anti-inflammatory nutraceutical The intervention will be provided as follows: - Weeks 0–8: All receive a semi-essential amino acid. - Weeks 9-16: Continue a semi-essential amino acid + randomised to either a vascular-active, anti-inflammatory nutraceutical or placebo daily. Capsule counts will be conducted at study visits to ensure adequate adherence to intervention protocol.
Arm 1 (comparator arm); oral capsules of 1.5 g L-arginine (L-arg) daily for 8 weeks, then 1.5 g L-arginine + 0.2 g placebo daily for 8 weeks (temporally separated)
Arm 2 (intervention arm): oral capsules of 1.5 g L-arginine daily for 8 weeks, then 1.5 g L-arginine + 0.2 g garlic extract (GE) daily for 8 weeks (temporally separated)
To monitor adherence, capsule counts will be done by the investigatory team when the participants return their capsule bottles on their subsequent visit (they will
Arm 1 (comparator arm); oral capsules of 1.5 g L-arginine (L-arg) daily for 8 weeks, then 1.5 g L-arginine + 0.2 g placebo daily for 8 weeks (temporally separated) Arm 2 (intervention arm): oral capsules of 1.5 g L-arginine daily for 8 weeks, then 1.5 g L-arginine + 0.2 g garlic extract (GE) daily for 8 weeks (temporally separated) To monitor adherence, capsule counts will be done by the investigatory team when the participants return their capsule bottles on their subsequent visit (they will have been asked to do so). The first 8 weeks of each arm are open-label, in that both investigator and participant know they are receiving L-arginine. The next 8 weeks will be double-blind, in that participants will have been randomised to either arm at enrolment, and neither investigator nor participant know which of garlic extract or placebo they will be receiving on top of their L-arginine.
Sponsors
Curtin
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 No maximum
Healthy volunteers
No
Inclusion criteria
1. Migraine (with or without aura) diagnosis at least 12 months ago 2. Migraine onset occurred before 50 years of age 3. Males and females, aged at least 18 years at screening 4. At least one migraine a week, averaged over the previous 3 months 5. Able to differentiate between migraine and “other” headache types
Exclusion criteria
1. Any change in medications that affect blood vessel width or blood pressure during the study 2. Diagnosis of headache disorder, facial pain disorder or other neurological disorder other than migraine 3. Change in migraine treatment in previous 3 months 4. Taking L-arginine tablets or garlic extracts in previous 3 months 5. Known allergies to foods containing L-arginine or garlic 6. Known risks of bleeding or coagulopathy, or currently on blood-thinning medications 7. Active cancer diagnosis with exception to cancers of the skin such as basal or squamous cell carcinoma in situ of the skin 8. Presence of acute/chronic pain disorders, infections, cardiovascular or cerebrovascular disease 9. Diagnoses other than migraine as primary cause of headaches 11. Procedure or injection to treat migraine over past 3 months 12. Implanted or external nerve stimulator to treat migraines 13. History of diabetes, hypertension, hypotension, collagen vascular disease, vasculitis, or renal disease/failure 14. Smoke >1 pack of cigarettes a day 15. Clinically significant anaemia or iron deficiency 16. Participation in concurrent research study
Outcome results
None listed