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Th Effect of Ketogenic Metabolic Nutritional Pattern on High-frequency Episodic Migraine (EMIKETO) — EMIKETO  

Overweight Clinical Trial

Official title:
Randomized-controlled Study for Evaluation of Ketogenic Metabolic Nutritional Pattern in Subjects With High-frequency Episodic Migraine

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04360148
Study type Interventional
Source New Penta SRL
Contact
Status Active, not recruiting
Phase N/A
Start date February 6, 2020
Completion date May 30, 2021
View Details
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