A Randomized Double-Blind, Cross-Over Trial of very Low-Calorie Diet in Overweight Migraine Patients: A Possible Role for Ketones?

Here we aimed at determining the therapeutic effect of a very low-calorie diet in overweight episodic migraine patients during a weight-loss intervention in which subjects alternated randomly between a very low-calorie ketogenic diet (VLCKD) and a very low-calorie non-ketogenic diet (VLCnKD) each fo...

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Published inNutrients Vol. 11; no. 8; p. 1742
Main Authors Di Lorenzo, Cherubino, Pinto, Alessandro, Ienca, Roberta, Coppola, Gianluca, Sirianni, Giulio, Di Lorenzo, Giorgio, Parisi, Vincenzo, Serrao, Mariano, Spagnoli, Alessandra, Vestri, Annarita, Schoenen, Jean, Donini, Lorenzo M, Pierelli, Francesco
Format Journal Article Web Resource
LanguageEnglish
Published Switzerland MDPI AG 28.07.2019
MDPI
Subjects
Adult
Analgesics - therapeutic use
Attacks frequency
Body Mass Index
Caloric Restriction
Carbohydrates
Cross-Over Studies
Diet
Diet, Ketogenic
Double-Blind Method
Double-blind studies
drugs
Female
Flow velocity
Food
Human health sciences
Humans
ketogenic diet
Ketone bodies
ketones
Ketosis
Low-calorie
Low-carbohydrate
Male
Metabolism
Middle Aged
Migraine
Migraine Disorders - diagnosis
Migraine Disorders - diet therapy
Migraine Disorders - physiopathology
Neurologie
Neurology
Neurosciences
Obesity
Oils & fats
overweight
Overweight - diagnosis
Overweight - diet therapy
Overweight - physiopathology
patients
Proteins
Public health
Rome
Sciences de la santé humaine
therapeutics
Time Factors
Treatment Outcome
very low calorie diet
Weight control
Weight Loss
Rome
Italy
low-carbohydrate
attacks frequency
ketosis
migraine
weight loss
low-calorie
ketone bodies
Online AccessGet full text

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Abstract Here we aimed at determining the therapeutic effect of a very low-calorie diet in overweight episodic migraine patients during a weight-loss intervention in which subjects alternated randomly between a very low-calorie ketogenic diet (VLCKD) and a very low-calorie non-ketogenic diet (VLCnKD) each for one month. In a nutritional program, 35 overweight obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order (VLCKD-VLCnKD or VLCnKD-VLCD). The primary outcome measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Secondary outcome measures were 50% responder rate for migraine days, reduction of monthly migraine attacks, abortive drug intake and body mass index (BMI) change. Only data from the intention-to-treat cohort (n = 35) will be presented. Patients who dropped out (n = 6) were considered as treatment failures. Regarding the primary outcome, during the VLCKD patients experienced −3.73 (95% CI: −5.31, −2.15) migraine days respect to VLCnKD (p < 0.0001). The 50% responder rate for migraine days was 74.28% (26/35 patients) during the VLCKD period, but only 8.57% (3/35 patients) during VLCnKD. Migraine attacks decreased by −3.02 (95% CI: −4.15, −1.88) during VLCKD respect to VLCnKD (p < 0.00001). There were no differences in the change of acute anti-migraine drug consumption (p = 0.112) and BMI (p = 0.354) between the 2 diets. A VLCKD has a preventive effect in overweight episodic migraine patients that appears within 1 month, suggesting that ketogenesis may be a useful therapeutic strategy for migraines.
AbstractList Here we aimed at determining the therapeutic effect of a very low-calorie diet in overweight episodic migraine patients during a weight-loss intervention in which subjects alternated randomly between a very low-calorie ketogenic diet (VLCKD) and a very low-calorie non-ketogenic diet (VLCnKD) each for one month. In a nutritional program, 35 overweight obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order (VLCKD-VLCnKD or VLCnKD-VLCD). The primary outcome measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Secondary outcome measures were 50% responder rate for migraine days, reduction of monthly migraine attacks, abortive drug intake and body mass index (BMI) change. Only data from the intention-to-treat cohort (n = 35) will be presented. Patients who dropped out (n = 6) were considered as treatment failures. Regarding the primary outcome, during the VLCKD patients experienced −3.73 (95% CI: −5.31, −2.15) migraine days respect to VLCnKD (p < 0.0001). The 50% responder rate for migraine days was 74.28% (26/35 patients) during the VLCKD period, but only 8.57% (3/35 patients) during VLCnKD. Migraine attacks decreased by −3.02 (95% CI: −4.15, −1.88) during VLCKD respect to VLCnKD (p < 0.00001). There were no differences in the change of acute anti-migraine drug consumption (p = 0.112) and BMI (p = 0.354) between the 2 diets. A VLCKD has a preventive effect in overweight episodic migraine patients that appears within 1 month, suggesting that ketogenesis may be a useful therapeutic strategy for migraines. © 2019 by the authors. Licensee MDPI, Basel, Switzerland.
Here we aimed at determining the therapeutic effect of a very low-calorie diet in overweight episodic migraine patients during a weight-loss intervention in which subjects alternated randomly between a very low-calorie ketogenic diet (VLCKD) and a very low-calorie non-ketogenic diet (VLCnKD) each for one month. In a nutritional program, 35 overweight obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order (VLCKD-VLCnKD or VLCnKD-VLCD). The primary outcome measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Secondary outcome measures were 50% responder rate for migraine days, reduction of monthly migraine attacks, abortive drug intake and body mass index (BMI) change. Only data from the intention-to-treat cohort ( = 35) will be presented. Patients who dropped out ( = 6) were considered as treatment failures. Regarding the primary outcome, during the VLCKD patients experienced -3.73 (95% CI: -5.31, -2.15) migraine days respect to VLCnKD ( < 0.0001). The 50% responder rate for migraine days was 74.28% (26/35 patients) during the VLCKD period, but only 8.57% (3/35 patients) during VLCnKD. Migraine attacks decreased by -3.02 (95% CI: -4.15, -1.88) during VLCKD respect to VLCnKD ( < 0.00001). There were no differences in the change of acute anti-migraine drug consumption ( = 0.112) and BMI ( = 0.354) between the 2 diets. A VLCKD has a preventive effect in overweight episodic migraine patients that appears within 1 month, suggesting that ketogenesis may be a useful therapeutic strategy for migraines.
Here we aimed at determining the therapeutic effect of a very low-calorie diet in overweight episodic migraine patients during a weight-loss intervention in which subjects alternated randomly between a very low-calorie ketogenic diet (VLCKD) and a very low-calorie non-ketogenic diet (VLCnKD) each for one month. In a nutritional program, 35 overweight obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order (VLCKD-VLCnKD or VLCnKD-VLCD). The primary outcome measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Secondary outcome measures were 50% responder rate for migraine days, reduction of monthly migraine attacks, abortive drug intake and body mass index (BMI) change. Only data from the intention-to-treat cohort (n = 35) will be presented. Patients who dropped out (n = 6) were considered as treatment failures. Regarding the primary outcome, during the VLCKD patients experienced −3.73 (95% CI: −5.31, −2.15) migraine days respect to VLCnKD (p < 0.0001). The 50% responder rate for migraine days was 74.28% (26/35 patients) during the VLCKD period, but only 8.57% (3/35 patients) during VLCnKD. Migraine attacks decreased by −3.02 (95% CI: −4.15, −1.88) during VLCKD respect to VLCnKD (p < 0.00001). There were no differences in the change of acute anti-migraine drug consumption (p = 0.112) and BMI (p = 0.354) between the 2 diets. A VLCKD has a preventive effect in overweight episodic migraine patients that appears within 1 month, suggesting that ketogenesis may be a useful therapeutic strategy for migraines.
Here we aimed at determining the therapeutic effect of a very low-calorie diet in overweight episodic migraine patients during a weight-loss intervention in which subjects alternated randomly between a very low-calorie ketogenic diet (VLCKD) and a very low-calorie non-ketogenic diet (VLCnKD) each for one month. In a nutritional program, 35 overweight obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order (VLCKD-VLCnKD or VLCnKD-VLCD). The primary outcome measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Secondary outcome measures were 50% responder rate for migraine days, reduction of monthly migraine attacks, abortive drug intake and body mass index (BMI) change. Only data from the intention-to-treat cohort (n = 35) will be presented. Patients who dropped out (n = 6) were considered as treatment failures. Regarding the primary outcome, during the VLCKD patients experienced -3.73 (95% CI: -5.31, -2.15) migraine days respect to VLCnKD (p < 0.0001). The 50% responder rate for migraine days was 74.28% (26/35 patients) during the VLCKD period, but only 8.57% (3/35 patients) during VLCnKD. Migraine attacks decreased by -3.02 (95% CI: -4.15, -1.88) during VLCKD respect to VLCnKD (p < 0.00001). There were no differences in the change of acute anti-migraine drug consumption (p = 0.112) and BMI (p = 0.354) between the 2 diets. A VLCKD has a preventive effect in overweight episodic migraine patients that appears within 1 month, suggesting that ketogenesis may be a useful therapeutic strategy for migraines.Here we aimed at determining the therapeutic effect of a very low-calorie diet in overweight episodic migraine patients during a weight-loss intervention in which subjects alternated randomly between a very low-calorie ketogenic diet (VLCKD) and a very low-calorie non-ketogenic diet (VLCnKD) each for one month. In a nutritional program, 35 overweight obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order (VLCKD-VLCnKD or VLCnKD-VLCD). The primary outcome measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Secondary outcome measures were 50% responder rate for migraine days, reduction of monthly migraine attacks, abortive drug intake and body mass index (BMI) change. Only data from the intention-to-treat cohort (n = 35) will be presented. Patients who dropped out (n = 6) were considered as treatment failures. Regarding the primary outcome, during the VLCKD patients experienced -3.73 (95% CI: -5.31, -2.15) migraine days respect to VLCnKD (p < 0.0001). The 50% responder rate for migraine days was 74.28% (26/35 patients) during the VLCKD period, but only 8.57% (3/35 patients) during VLCnKD. Migraine attacks decreased by -3.02 (95% CI: -4.15, -1.88) during VLCKD respect to VLCnKD (p < 0.00001). There were no differences in the change of acute anti-migraine drug consumption (p = 0.112) and BMI (p = 0.354) between the 2 diets. A VLCKD has a preventive effect in overweight episodic migraine patients that appears within 1 month, suggesting that ketogenesis may be a useful therapeutic strategy for migraines.
Furthermore, the protein sparing modified fast (PSMF), a modified variant of VLCD, was designed to exploit quasi-fasting induced ketosis to preserve lean body mass when following major weight loss programs, as widely studied and described by Dr. George Blackburn [11]. Because of their ability to induce ketosis by the mobilization of fatty acids from adipose tissue (physiological states of prolonged fasting), PSMF protocols are also called very low-calorie ketogenic diets (VLCKDs). [5,6], we compared overweight individuals experiencing migraines and who followed VLCKD to patients prescribed with a standard non-ketogenic hypocaloric diet in a proof-of-concept, prospective, observational pilot study, and found a beneficial effect of VLCKD on various clinical features of migraine features [15]. Because of the lack of randomization and blinding, the encouraging results described herein needed to be further validated by a randomized, controlled, double-blind trial. [...]the use of a cross over design; this choice was due to the more limited number of subjects required by this type of study design and the greater accuracy due to the comparison of each subject in both conditions. [...]the number of patients and the duration of treatment periods were limited.
Here we aimed at determining the therapeutic effect of a very low-calorie diet in overweight episodic migraine patients during a weight-loss intervention in which subjects alternated randomly between a very low-calorie ketogenic diet (VLCKD) and a very low-calorie non-ketogenic diet (VLCnKD) each for one month. In a nutritional program, 35 overweight obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order (VLCKD-VLCnKD or VLCnKD-VLCD). The primary outcome measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Secondary outcome measures were 50% responder rate for migraine days, reduction of monthly migraine attacks, abortive drug intake and body mass index (BMI) change. Only data from the intention-to-treat cohort ( n = 35) will be presented. Patients who dropped out ( n = 6) were considered as treatment failures. Regarding the primary outcome, during the VLCKD patients experienced −3.73 (95% CI: −5.31, −2.15) migraine days respect to VLCnKD ( p < 0.0001). The 50% responder rate for migraine days was 74.28% (26/35 patients) during the VLCKD period, but only 8.57% (3/35 patients) during VLCnKD. Migraine attacks decreased by −3.02 (95% CI: −4.15, −1.88) during VLCKD respect to VLCnKD ( p < 0.00001). There were no differences in the change of acute anti-migraine drug consumption ( p = 0.112) and BMI ( p = 0.354) between the 2 diets. A VLCKD has a preventive effect in overweight episodic migraine patients that appears within 1 month, suggesting that ketogenesis may be a useful therapeutic strategy for migraines.
Author Pierelli, Francesco
Di Lorenzo, Giorgio
Sirianni, Giulio
Ienca, Roberta
Schoenen, Jean
Di Lorenzo, Cherubino
Spagnoli, Alessandra
Pinto, Alessandro
Parisi, Vincenzo
Coppola, Gianluca
Donini, Lorenzo M
Vestri, Annarita
Serrao, Mariano
AuthorAffiliation 4 Associazione Eupraxia, Dietary Section, 00171 Rome, Italy
3 Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome Polo Pontino, 04100 Latina, Italy
9 Headache Research Unit, University Department of Neurology CHR, Citadelle Hospital, University of Liège, 4000 Liège, Belgium
7 IRCCS–Fondazione Bietti, 00198 Rome, Italy
10 IRCCS–Neuromed, 86077 Pozzilli (IS), Italy
8 Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00161 Rome, Italy
5 Laboratory of Psychophysiology and Cognitive Neuroscience, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy
1 IRCCS–Fondazione Don Carlo Gnocchi, 20121 Milan, Italy
2 Department of Experimental Medicine, Sapienza University of Rome, 00161 Roma, Italy
6 IRCCS Fondazione Santa Lucia, 00142 Rome, Italy
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/31357685$$D View this record in MEDLINE/PubMed
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Copyright 2019. This work is licensed under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
2019 by the authors. 2019
Copyright_xml – notice: 2019. This work is licensed under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
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Keywords low-carbohydrate
attacks frequency
ketosis
migraine
weight loss
low-calorie
ketone bodies
Language English
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Snippet Here we aimed at determining the therapeutic effect of a very low-calorie diet in overweight episodic migraine patients during a weight-loss intervention in...
Furthermore, the protein sparing modified fast (PSMF), a modified variant of VLCD, was designed to exploit quasi-fasting induced ketosis to preserve lean body...
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StartPage 1742
SubjectTerms Adult
Analgesics - therapeutic use
Attacks frequency
Body Mass Index
Caloric Restriction
Carbohydrates
Cross-Over Studies
Diet
Diet, Ketogenic
Double-Blind Method
Double-blind studies
drugs
Female
Flow velocity
Food
Human health sciences
Humans
ketogenic diet
Ketone bodies
ketones
Ketosis
Low-calorie
Low-carbohydrate
Male
Metabolism
Middle Aged
Migraine
Migraine Disorders - diagnosis
Migraine Disorders - diet therapy
Migraine Disorders - physiopathology
Neurologie
Neurology
Neurosciences
Obesity
Oils & fats
overweight
Overweight - diagnosis
Overweight - diet therapy
Overweight - physiopathology
patients
Proteins
Public health
Rome
Sciences de la santé humaine
therapeutics
Time Factors
Treatment Outcome
very low calorie diet
Weight control
Weight Loss
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Title A Randomized Double-Blind, Cross-Over Trial of very Low-Calorie Diet in Overweight Migraine Patients: A Possible Role for Ketones?
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