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Trial registered on ANZCTR


Registration number
ACTRN12619001089123
Ethics application status
Approved
Date submitted
9/07/2019
Date registered
7/08/2019
Date last updated
7/08/2019
Date data sharing statement initially provided
7/08/2019
Date results information initially provided
7/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and acceptability of a personalised healthy diet versus a medical nutrition therapy
ketogenic diet in reducing migraine frequency and severity
Scientific title
Feasibility and acceptability of a personalised healthy diet versus a medical nutrition therapy
ketogenic diet in reducing migraine frequency and severity
Secondary ID [1] 297669 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 313494 0
Condition category
Condition code
Neurological 311914 311914 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 314887 0
Treatment: Other
Comparator / control treatment
During the comparator '4-week anti-headache' diet, participants will be instructed to drink an additional 1.5 litres of water daily on top of their usual intake, to maintain their caffeine intake (not increase or decrease), to avoid alcohol and fasting and encouraged to eat consistently by having regular daily meal/snack times (no longer than 3 hours between meals/snacks) during waking hours. Participants will also receive instruction on meeting dietary guidelines for the five food groups. Participants also complete the image-based dietary record during the 4 weeks and Australian Eating Survey FFQ before and after the comparator diet to measure adherence.
Control group
Active

Outcomes
Primary outcome [1] 320585 0
Participants answered questions regarding their migraine frequency in a smartphone app 'Migraine Buddy' throughout each 4 week intervention period. Data from this were used to assess the primary outcome.
Timepoint [1] 320585 0
During each 4 week dietary intervention. Frequency of data collection for this outcome can not be specified as the data is only collected if/when a migraine occurs during each 4 week dietary intervention. If a migraine occurs daily, we ask that participants record this information daily.
Primary outcome [2] 320926 0
Participants answered questions regarding their migraine severity in a smartphone app 'Migraine Buddy' throughout each 4 week intervention period. Data from this were used to assess the primary outcome.
Timepoint [2] 320926 0
During each 4 week dietary intervention. Frequency of data collection for this outcome can not be specified as the data is only collected if/when a migraine occurs during each 4 week dietary intervention. If a migraine occurs daily, we ask that participants record this information daily.
Primary outcome [3] 320928 0
Participants answered questions regarding their migraine duration in a smartphone app 'Migraine Buddy' throughout each 4 week intervention period. Data from this were used to assess the primary outcome.
Timepoint [3] 320928 0
During each 4 week dietary intervention. Frequency of data collection for this outcome cannot be specified as the data is only collected if/when a migraine occurs during each 4 week dietary intervention. If a migraine occurs daily, we ask that participants record this information daily.
Secondary outcome [1] 372111 0
Participants were asked to keep a symptom diary to assess tolerability and feasibility of the dietary intervention. They were provided a list of symptoms and were asked to tick off any day across the 4 weeks that they experienced any of the symptoms listed or were given the option to record other symptoms.
Timepoint [1] 372111 0
During each 4 week dietary intervention. Frequency of data collection for this outcome cannot be specified as the data is only collected if/when a symptom occurs during each 4 week dietary intervention. If a symptom occurs daily, we ask that participants record this information daily.

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302198 0
Charities/Societies/Foundations
Name [1] 302198 0
Hunter Medical Research Institute
Address [1] 302198 0
Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
Country [1] 302198 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University of Newcastle, University Drive, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 303172 0
None
Name [1] 303172 0
Address [1] 303172 0
Country [1] 303172 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302877 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 302877 0
University Drive, Callaghan, NSW 2308, Australia
Ethics committee country [1] 302877 0
Australia
Date submitted for ethics approval [1] 302877 0
Approval date [1] 302877 0
16/03/2018
Ethics approval number [1] 302877 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91702 0
Prof Clare Collins
Address 91702 0
University of Newcastle, ATC Building, Room 310, University Drive, Callaghan, NSW, 2308
Country 91702 0
Australia
Phone 91702 0
+61 02 4921 5646
Fax 91702 0
Email 91702 0
clare.collins@newcastle.edu.au
Contact person for public queries
Name 91703 0
Dr Rebecca Haslam
Address 91703 0
University of Newcastle, ATC Building, Room 205, University Drive, Callaghan, NSW, 2308
Country 91703 0
Australia
Phone 91703 0
+61 02 4921 7862
Fax 91703 0
Email 91703 0
rebecca.williams@newcastle.edu.au
Contact person for scientific queries
Name 91704 0
Dr Rebecca Haslam
Address 91704 0
University of Newcastle, ATC Building, Room 205, University Drive, Callaghan, NSW, 2308
Country 91704 0
Australia
Phone 91704 0
+61 02 4921 7862
Fax 91704 0
Email 91704 0
rebecca.williams@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this stage we do not have ethics approval for individual data to be shared publicly.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary