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Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study

INTRODUCTION: Obesity can worsen fibromyalgia (FM) and very low-calorie ketogenic diet (VLCKD) is a potential therapeutic option for diseases that share clinical and pathophysiological features with FM. In this pilot interventional study, we investigated the effects of VLCKD in obese women with FM....

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Autores principales: Ciaffi, Jacopo, Lisi, Lucia, Mari, Anna, Mancarella, Luana, Brusi, Veronica, Pignatti, Federica, Ricci, Susanna, Vitali, Giorgia, Stefanelli, Nicola, Assirelli, Elisa, Neri, Simona, Naldi, Susanna, Faldini, Cesare, Ursini, Francesco
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10369071/
https://www.ncbi.nlm.nih.gov/pubmed/37502721
http://dx.doi.org/10.3389/fnut.2023.1219321
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author Ciaffi, Jacopo
Lisi, Lucia
Mari, Anna
Mancarella, Luana
Brusi, Veronica
Pignatti, Federica
Ricci, Susanna
Vitali, Giorgia
Stefanelli, Nicola
Assirelli, Elisa
Neri, Simona
Naldi, Susanna
Faldini, Cesare
Ursini, Francesco
author_facet Ciaffi, Jacopo
Lisi, Lucia
Mari, Anna
Mancarella, Luana
Brusi, Veronica
Pignatti, Federica
Ricci, Susanna
Vitali, Giorgia
Stefanelli, Nicola
Assirelli, Elisa
Neri, Simona
Naldi, Susanna
Faldini, Cesare
Ursini, Francesco
author_sort Ciaffi, Jacopo
collection PubMed
description INTRODUCTION: Obesity can worsen fibromyalgia (FM) and very low-calorie ketogenic diet (VLCKD) is a potential therapeutic option for diseases that share clinical and pathophysiological features with FM. In this pilot interventional study, we investigated the effects of VLCKD in obese women with FM. METHODS: Female patients with FM and a body mass index (BMI) ≥ 30  kg/m(2) were eligible for VLCKD. The ketogenic phase (T0 to T8) was followed by progressive reintroduction of carbohydrates (T8 to T20). Changes in BMI, Fibromyalgia Impact Questionnaire (FIQ), Hospital Anxiety and Depression Scale (HADS), EuroQol 5D (EQ-5D) and 36-item Short Form Health Survey (SF-36) were evaluated. A change of 14% in FIQ was considered clinically relevant. The longitudinal association between BMI and patient-reported outcomes (PROs) was assessed using generalized estimating equations. RESULTS: Twenty women were enrolled. Two discontinued the intervention. The mean age of the 18 patients who reached T20 was 51.3  years and mean BMI was 37.2  kg/m(2). All patients lost weight during the first period of VLCKD and this achievement was maintained at T20. Mean BMI decreased from 37.2  kg/m(2) at T0 to 34.8  kg/m(2) at T4, 33.5  kg/m(2) at T8 and 32.1  kg/m(2) at T20 (p < 0.001). A significant reduction of mean FIQ from 61.7 at T0 to 37.0 at T4 and to 38.7 at T8 (p < 0.001) was observed and it was maintained at T20 with a mean FIQ of 39.1 (p = 0.002). Similar results were obtained for HADS, EQ-5D and SF-36. Analysing each participant, the reduction of FIQ was clinically meaningful in 16 patients (89%) at T4, in 13 (72%) at T8 and in 14 (78%) at T20. No significant association was observed between change in BMI and improvement of the PROs over time. Adverse effects were mild and transient. No major safety concerns emerged. CONCLUSION: These are the first data on the efficacy of VLCKD in FM. All patients achieved improvement in different domains of the disease, which was maintained also after carbohydrate reintroduction. Our results suggest that ketosis might exert beneficial effects in FM beyond the rapid weight loss. CLINICAL TRIAL REGISTRATION: This trial is registered on ClinicalTrials.gov, number NCT05848544.
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spelling pubmed-103690712023-07-27 Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study Ciaffi, Jacopo Lisi, Lucia Mari, Anna Mancarella, Luana Brusi, Veronica Pignatti, Federica Ricci, Susanna Vitali, Giorgia Stefanelli, Nicola Assirelli, Elisa Neri, Simona Naldi, Susanna Faldini, Cesare Ursini, Francesco Front Nutr Nutrition INTRODUCTION: Obesity can worsen fibromyalgia (FM) and very low-calorie ketogenic diet (VLCKD) is a potential therapeutic option for diseases that share clinical and pathophysiological features with FM. In this pilot interventional study, we investigated the effects of VLCKD in obese women with FM. METHODS: Female patients with FM and a body mass index (BMI) ≥ 30  kg/m(2) were eligible for VLCKD. The ketogenic phase (T0 to T8) was followed by progressive reintroduction of carbohydrates (T8 to T20). Changes in BMI, Fibromyalgia Impact Questionnaire (FIQ), Hospital Anxiety and Depression Scale (HADS), EuroQol 5D (EQ-5D) and 36-item Short Form Health Survey (SF-36) were evaluated. A change of 14% in FIQ was considered clinically relevant. The longitudinal association between BMI and patient-reported outcomes (PROs) was assessed using generalized estimating equations. RESULTS: Twenty women were enrolled. Two discontinued the intervention. The mean age of the 18 patients who reached T20 was 51.3  years and mean BMI was 37.2  kg/m(2). All patients lost weight during the first period of VLCKD and this achievement was maintained at T20. Mean BMI decreased from 37.2  kg/m(2) at T0 to 34.8  kg/m(2) at T4, 33.5  kg/m(2) at T8 and 32.1  kg/m(2) at T20 (p < 0.001). A significant reduction of mean FIQ from 61.7 at T0 to 37.0 at T4 and to 38.7 at T8 (p < 0.001) was observed and it was maintained at T20 with a mean FIQ of 39.1 (p = 0.002). Similar results were obtained for HADS, EQ-5D and SF-36. Analysing each participant, the reduction of FIQ was clinically meaningful in 16 patients (89%) at T4, in 13 (72%) at T8 and in 14 (78%) at T20. No significant association was observed between change in BMI and improvement of the PROs over time. Adverse effects were mild and transient. No major safety concerns emerged. CONCLUSION: These are the first data on the efficacy of VLCKD in FM. All patients achieved improvement in different domains of the disease, which was maintained also after carbohydrate reintroduction. Our results suggest that ketosis might exert beneficial effects in FM beyond the rapid weight loss. CLINICAL TRIAL REGISTRATION: This trial is registered on ClinicalTrials.gov, number NCT05848544. Frontiers Media S.A. 2023-07-12 /pmc/articles/PMC10369071/ /pubmed/37502721 http://dx.doi.org/10.3389/fnut.2023.1219321 Text en Copyright © 2023 Ciaffi, Lisi, Mari, Mancarella, Brusi, Pignatti, Ricci, Vitali, Stefanelli, Assirelli, Neri, Naldi, Faldini and Ursini. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Nutrition
Ciaffi, Jacopo
Lisi, Lucia
Mari, Anna
Mancarella, Luana
Brusi, Veronica
Pignatti, Federica
Ricci, Susanna
Vitali, Giorgia
Stefanelli, Nicola
Assirelli, Elisa
Neri, Simona
Naldi, Susanna
Faldini, Cesare
Ursini, Francesco
Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study
title Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study
title_full Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study
title_fullStr Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study
title_full_unstemmed Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study
title_short Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study
title_sort efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study
topic Nutrition
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10369071/
https://www.ncbi.nlm.nih.gov/pubmed/37502721
http://dx.doi.org/10.3389/fnut.2023.1219321
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