Efficacy of a nutritional ketogenic supplement (NKS) in reducing the number, intensity, and duration of migraine headaches in episodic migraine patients.
The KEMIP study is a randomized, placebo-controlled, double-blind, full cross-over, study to test the efficacy of NKS at reducing migraine days per month (MDM) compared to placebo in episodic migraine participants. Participants will prompted to enter data on migraine headache features (duration, pain intensity, medication use, symptoms) and product intake in an eDiary every day throughout the course of the study. Each participant will complete five steps of 1 month each: (1) baseline evaluation; (2) NKS/placebo intake; (3) washout \& cross-over; (4) NKS/placebo intake; (5) follow-up
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
This trial has 5 steps: (1) a 4-week run-in baseline; (2) a 4-week intervention phase to either active or placebo (3) a 4-week phase of washout; (4) the cross-over to the second 4-week active or placebo phase; (5) a 4-week follow-up.
Isocaloric placebo supplement
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Mean change from baseline in MDM versus placebo
Headache eDiary will be used to record the change in monthly migraine frequency according to ICHD-3 guidelines. The headache diary captures information on date, time of onset and resolution, distinction of migraine from headache based on symptoms, pain intensity and use of acute medication
Time frame: 1 month
Mean change from baseline in the number of headache days of any severity (headache, migraine or probable migraine, and migraine attacks)
Time frame: 1 month
Proportion of responders: responders are defined as patients who had a greater than 50%, 75% or 100% reduction in MDM
Time frame: 1 month
Reduction in the use of acute medication for migraine
Time frame: 1 month
Mean change from baseline in migraine intensity measured with a numerical rating scale from 1 to 10;
Time frame: 1 month
Mean change from baseline in the average migraine duration
Time frame: 1 month
Incidence, severity and relatedness of adverse events
Time frame: 8 months
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