None listed
Conditions
Brief summary
Our aim is to determine which of two dietary approaches is more effective in reducing migraine frequency, severity and duration in individuals within the community who identify as migraine sufferers. In a randomised cross-over trial, we will evaluate the feasibility, acceptability and efficacy of a ketogenic diet (high in fat, low in total carbohydrate) compared to an ‘anti-headache diet’ we have developed based on common triggers identified by our review of the research evidence. The value of this study will be the potential to improve quality of life, reduce functional impairment and reduce the need for or dose of medications in individuals who experience frequent or severe migraine. Clinicians will also benefit from an increased knowledge of food triggers and dietary strategies that can aid in the management of migraine.
Interventions
During the 4-week ketogenic diet intervention, a calorie level will be determined by a dietitian for each participant based on their age and activity level. To achieve a desired level of ketosis, the diet is calculated in terms of a ratio (3:1), where there is 3 times as much fat as there is protein and carbohydrate combined. Total carbohydrate for the day will be restricted to 5% of total energy intake. The dietitian will assist in developing a meal plan that contains the required fat, protein and carbohydrate for each meal. Each meal plan indicates the exact gram weight of each food which must be weighed on kitchen scales. A typical meal includes a small amount of fruit or vegetable, a protein rich food, and a source of fat such as heavy cream and butter or vegetable oil. Participants will also be provided with recipe suggestions to assist with making food and meal choices outside of the meal plan. The most common adverse effect of the diet is constipation. There are dietary options to prevent this problem including eating high fibre vegetables that are allowed on the diet and drinking enough water. A less common adverse effect is kidney stones. This problem can be prevented by drinking adequate water. The dietitian will discuss these dietary requirements with the participant. Adherence to the diet will be monitored via an image-based food record whereby participant take photos of their meals each day and add a text description of the meal. The images then sync with the research teams account and the dietitian reviews these and contacts participant if changes need to be made. Participants also complete the Australian Eating Survey before and after the intervention, a FFQ assessing food group, macro- and micronutrient intake. Following the 4 week intervention diet, participants follow a 4 week washout diet where they resume normal eating for this duration.
Sponsors
Study design
Eligibility
Inclusion criteria
Males and females aged 16 years or over who have a history of migraine headaches consisting of at least two episodes of moderate intensity headache (or greater), or at least 5 episodes of mildly intense headache in the previous 4 weeks, with 50% of headache days being migraine or probable migraine days. We also need participants to own a smartphone. Participants aged 16-17 years will require parental consent.
Exclusion criteria
Diagnosed with any other neurological condition e.g. epilepsy or trauma, or have a medical condition requiring specific MNT (e.g. diabetes or coeliac disease), have a past history of stroke or have a pacemaker, or are currently taking medications contraindicated whilst on a ketogenic diet (e.g. blood pressure medication or insulin), are pregnant or breastfeeding, are not proficient in the English language, or have an intellectual or mental impairment where decision making capacity is compromised, or do not own a smartphone