Overweight Clinical Trial
Official title:
Randomized-controlled Study for Evaluation of Ketogenic Metabolic Nutritional Pattern in Subjects With High-frequency Episodic Migraine
The study aims to investigate the impact of 2 nutritional patterns on high-frequency episodic migraine. Subjects enrolled will be randomized in two arms: a) very-low-calorie-ketogenic-diet (VLCKD), b) hypocaloric balanced non ketogenic-diet (HBD).
This randomized controlled trial aims to:
- investigate the impact of very-low-calorie-ketogenic-diet (VLCKD) compared to
hypocaloric balanced non ketogenic-diet (HBD) on high-frequency episodic migraine
- evaluate the impact of VLCKD or HBD on immune system, with particular regard to
inflammatory and regulatory T cells
- assess aldosterone blood levels before and after VLCKD or HBD treatment The
randomization will be carry out at the single center using an a proper software.
All the eligible subjects (please, see the inclusion and exclusion criteria), will be
randomized in two groups. Both VLCKD or HBD will be undergone to 24 weeks of diet. For VLCKD-
group, the ketogenic period will be maintained for 8 weeks. In the following four weeks,
carbohydrates are gradually reintroduced, starting from foods with the lowest glycemic index
(fruit, dairy products), followed by foods with moderate and high glycemic index (bread,
pasta and cereals). The goal is to achieve a hypocaloric balanced diet (HBD), as well as the
controlled group. From the 12th week to the 24 th week, all subjects enrolled will continue
follow-up with HBD. Periodically, subjects will be monitored through physical examination
(anthropometric measurements, blood pressure, heart rate, etc.) and laboratory analysis.
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