CompletedPhase 2ACTRN12620000180910

Can Resveratrol Supplementation Mitigate Menstrual Migraine? (Resveratrol for Menstrual Migraine - RESFORMM)

Can Resveratrol Supplementation Mitigate Menstrual Migraine?

Sponsor

The University of Newcastle

Enrollment

145 participants

Start Date

Mar 16, 2020

Study Type

Interventional

Conditions

Migraine

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.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria1

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 Criteria19

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

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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 cyc

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.