Personalized low-glycemic dietary intervention for the prophylaxis of migraine – a pilot study.

Background In migraine, reports of specific metabolic changes and especially insulin resistance point to metabolic involvement in the pathophysiology. As a result, nutritional interventions are being discussed as appropriate migraine prophylaxis. The Mobile Medical Application (MMA) sinCephalea leverages the concept of a low-glycemic diet and facilitates long-lasting implementability through digital personalization strategies.

Aims and objectives A pilot study on episodic migraine patients with an observation period of 12 weeks served to test the applicability of the MMA sinCephalea. Further, it generated first efficacy data to evaluate possible associations between the occurrence of migraine attacks and tissue glucose levels.

Methods 54 migraine patients with 3 to 14 migraine days per month received sinCephalea. All patients underwent a two-week test period. In this test period, defined test meals were eaten besides their typical daily diet recorded via the MMA. At the same time, the patients wore a glucose sensor for continuous glucose monitoring (CGM). At the end of the test period, personalized dietary recommendations for a low-glycemic diet were generated based on the individual measurement data. All patients were asked to implement these recommendations for 12 weeks and received coaching to improve implementation. In parallel, patients answered questions on adherence (weekly) and daily life impairment due to migraine measured by MIDAS and HIT-6 (4-weekly). Migraine attacks were documented by a headache e-diary over this period. Statistical analysis was performed using the Mann-Whitney U test.

Results After 12 weeks of intervention, data from 49 individuals from the headache e-diary could be analyzed. There was a mean intraindividual reduction of 2.4 migraine days (SD 3.2; p≤0.001), corresponding to 62.5% mean reduction, 73.5% reported at least a 50% reduction in migraine days ("responders"). Patients had a mean age of 41.0 years (±9.2 years), a body mass index (BMI) of 27.1 (±7.3) kg/m2, 43 were female and 6 male. Overall 39 reported adherence to dietary recommendations for at least 50% of meals eaten.

For the secondary endpoints, HIT-6 questionnaire n=33 and MIDAS n=34 data were available after intervention. Median individual improvement in MIDAS score was 46.1% (p=0.007, from 25 to 15 points median, Reduction of 10 points) and in HIT-6 was 13.0% (p=0.001, before 62.0, after 57.5 points). As measured by the MIDAS, 41.2% were scored as responders 50% (at least 50% reduction) and 61.8% were scored as responders 30% (at least 30% reduction). This significant reduction of the secondary endpoints was still present in a follow-up analysis after 325–355 days.

Comparison of dietary and CGM data with a healthy age-, BMI-, and sex-matched comparison cohort revealed no difference in average dietary behavior (caloric, macronutrient, fiber intake, meal frequency, nightly fasting period) or glucose tolerance after a 55-g glucose challenge. Nevertheless, migraine patients spent significantly more time with glucose levels between 90 and 120 mg/dl (39.7%, p=0.003) and less below 75 mg/dl (72.2%, p<0.001) on average over the entire period. This increase in mean glucose levels appeared more pronounced at night than during the day (mean glucose at night 6.0% higher, p<0.001, mean glucose during the day 3.9% higher, p=0.018).

Conclusions The 12-week use of sinCephalea reduced reported migraine days and migraine-related impairment in daily life. This is a clear indication of therapeutic efficacy in the treatment of migraine patients. This efficacy could be mediated by the low-glycemic approach, as migraine patients had elevated glucose data compared with healthy individuals with no differences in dietary behavior.

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Artikel online veröffentlicht:
05. Mai 2022