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

NCT04360148 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2020-04-24

No results posted yet for this study

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).

Conditions

Interventions

DIETARY_SUPPLEMENT

very-low-calorie-ketogenic-diet

VLCKD-group will undergone to VLCKD for 8 weeks. VLCKD is based on protein preparations of high biological value. Total daily energy intake is \< 800 kcal.Daily carbohydrate intake is lower than 30 g/day, while daily protein intake is approximately 1.2-1.5 g/kg of ideal body weight. 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.

OTHER

hypocaloric-balanced-diet

HBD-group will undergone to hypo caloric balanced diet for 24 weeks. Total daily average energy intake is 1500-1600 kcal/day. 30% of total daily energy is composed by lipids (10% MUFA, 10% PUFA, 10% SFA), 55% carbohydrates, while daily protein intake is approximately 0.8-1.5 g /kg of ideal body weight.

Sponsors & Collaborators

  • IRCCS San Raffaele

    collaborator OTHER

  • New Penta SRL

    lead INDUSTRY

Principal Investigators

  • Piero Barbanti, Prof. · IRCCS San Raffaele Pisana, 00163 Rome-Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-06
Primary Completion
2020-09-14
Completion
2021-05-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04360148 on ClinicalTrials.gov