None listed
Conditions
Brief summary
In our pilot observation, we found women who suffered from menstrual migraine to have poorer blood vessel function in the brain than women who did not suffer from migraine. Therefore, we hypothesise that improving and/or maintaining proper brain blood vessel function may potentially prevent the migraine from occurring. We believe that supplementing with resveratrol (a natural ingredient found in grapes and berries that is known to improve our cardiovascular and brain health) throughout the menstrual cycle may improve blood vessel function and ultimately prevent the menstrual migraine and improve the quality of life in sufferers. In this randomised, double-blind, placebo-controlled crossover trial, we will enrol 145 women aged between 18 and 50 who suffer from migraine +/- 3 days from their period for at least three out of their previous six menstrual cycles. Participants will take one 75mg resveratrol or one matching placebo capsule twice daily for three menstrual cycles before crossing over to the other treatment arm for another three menstrual cycles.
Interventions
This is a randomised, double-blind, placebo-controlled, crossover study.
Participants will take either 150mg of resveratrol (75mg, twice daily) or matching placebo capsules for three menstrual cycles before crossing over to the other treatment arm for another three menstrual cycles. Capsules will be taken orally. There will be no washout period between treatments.
Participants will return their supplement container and study diary to check compliance at each visit following the dispensing of
This is a randomised, double-blind, placebo-controlled, crossover study. Participants will take either 150mg of resveratrol (75mg, twice daily) or matching placebo capsules for three menstrual cycles before crossing over to the other treatment arm for another three menstrual cycles. Capsules will be taken orally. There will be no washout period between treatments. Participants will return their supplement container and study diary to check compliance at each visit following the dispensing of the supplement.
Sponsors
The University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Women aged between 18 - 50 years old who have a regular periods (menstrual cycle length between 21 and 35 days) and suffer from migraines that occur +/- 3 days from their period for at least three out of their previous six menstrual cycles
Exclusion criteria
Amenorrhea (absence of period for > 3 months but not pregnant) Currently consuming resveratrol containing supplements Currently receiving In Vitro Fertilisation (IVF) therapy Fibromyalgia History of alcohol or drug abuse History of using Botulinum toxin or neuromodulation devices or calcitonin gene-related peptide monoclonal antibody for treatment of migraine Hysterectomy Insulin-dependent diabetes Liver or kidney disease Malignant cancer Neurological conditions including stroke, TIA, multiple sclerosis, epilepsy, Chiari malformation or Parkinson’s disease Not fluent in reading and writing in English Pregnant or breastfeeding Polycystic ovarian syndrome or premature ovarian failure Taking prophylactic migraine medications or migraine prevention therapies Taking warfarin therapy or novel oral anticoagulants Unmanaged or untreated major depression Unwilling to provide a blood sample Unwilling to refrain from consuming stimulants before each clinic visit
Outcome results
None listed