Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study
IntroductionObesity 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.Met...
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2023-07-01
|
| Series: | Frontiers in Nutrition |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fnut.2023.1219321/full |
| _version_ | 1797782119050641408 |
|---|---|
| author | Jacopo Ciaffi Lucia Lisi Anna Mari Luana Mancarella Veronica Brusi Federica Pignatti Susanna Ricci Giorgia Vitali Nicola Stefanelli Elisa Assirelli Simona Neri Susanna Naldi Cesare Faldini Cesare Faldini Francesco Ursini Francesco Ursini |
| author_facet | Jacopo Ciaffi Lucia Lisi Anna Mari Luana Mancarella Veronica Brusi Federica Pignatti Susanna Ricci Giorgia Vitali Nicola Stefanelli Elisa Assirelli Simona Neri Susanna Naldi Cesare Faldini Cesare Faldini Francesco Ursini Francesco Ursini |
| author_sort | Jacopo Ciaffi |
| collection | DOAJ |
| description | IntroductionObesity 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.MethodsFemale patients with FM and a body mass index (BMI) ≥ 30 kg/m2 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.ResultsTwenty 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/m2. All patients lost weight during the first period of VLCKD and this achievement was maintained at T20. Mean BMI decreased from 37.2 kg/m2 at T0 to 34.8 kg/m2 at T4, 33.5 kg/m2 at T8 and 32.1 kg/m2 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.ConclusionThese 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 registrationThis trial is registered on ClinicalTrials.gov, number NCT05848544. |
| first_indexed | 2024-03-13T00:06:31Z |
| format | Article |
| id | doaj.art-2141319e783d43a38c2173adf6379d9f |
| institution | Directory Open Access Journal |
| issn | 2296-861X |
| language | English |
| last_indexed | 2024-03-13T00:06:31Z |
| publishDate | 2023-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Nutrition |
| spelling | doaj.art-2141319e783d43a38c2173adf6379d9f2023-07-13T00:02:21ZengFrontiers Media S.A.Frontiers in Nutrition2296-861X2023-07-011010.3389/fnut.2023.12193211219321Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional studyJacopo Ciaffi0Lucia Lisi1Anna Mari2Luana Mancarella3Veronica Brusi4Federica Pignatti5Susanna Ricci6Giorgia Vitali7Nicola Stefanelli8Elisa Assirelli9Simona Neri10Susanna Naldi11Cesare Faldini12Cesare Faldini13Francesco Ursini14Francesco Ursini15Medicine & Rheumatology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, ItalyMedicine & Rheumatology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, ItalyMedicine & Rheumatology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, ItalyMedicine & Rheumatology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, ItalyMedicine & Rheumatology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, ItalyMedicine & Rheumatology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, ItalyDietetic Service, IRCCS Istituto Ortopedico Rizzoli, Bologna, ItalyDietetic Service, IRCCS Istituto Ortopedico Rizzoli, Bologna, ItalyDietetic Service, IRCCS Istituto Ortopedico Rizzoli, Bologna, ItalyMedicine & Rheumatology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, ItalyMedicine & Rheumatology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, ItalyMedicine & Rheumatology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy1st Orthopaedic and Traumatology Department, IRCCS Istituto Ortopedico Rizzoli, Bologna, ItalyDepartment of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna, Bologna, ItalyMedicine & Rheumatology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, ItalyDepartment of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna, Bologna, ItalyIntroductionObesity 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.MethodsFemale patients with FM and a body mass index (BMI) ≥ 30 kg/m2 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.ResultsTwenty 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/m2. All patients lost weight during the first period of VLCKD and this achievement was maintained at T20. Mean BMI decreased from 37.2 kg/m2 at T0 to 34.8 kg/m2 at T4, 33.5 kg/m2 at T8 and 32.1 kg/m2 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.ConclusionThese 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 registrationThis trial is registered on ClinicalTrials.gov, number NCT05848544.https://www.frontiersin.org/articles/10.3389/fnut.2023.1219321/fullfibromyalgiaketone bodiespainobesityketogenic diet |
| spellingShingle | Jacopo Ciaffi Lucia Lisi Anna Mari Luana Mancarella Veronica Brusi Federica Pignatti Susanna Ricci Giorgia Vitali Nicola Stefanelli Elisa Assirelli Simona Neri Susanna Naldi Cesare Faldini Cesare Faldini Francesco Ursini Francesco Ursini Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study Frontiers in Nutrition fibromyalgia ketone bodies pain obesity ketogenic diet |
| 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 | fibromyalgia ketone bodies pain obesity ketogenic diet |
| url | https://www.frontiersin.org/articles/10.3389/fnut.2023.1219321/full |
| work_keys_str_mv | AT jacopociaffi efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy AT lucialisi efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy AT annamari efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy AT luanamancarella efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy AT veronicabrusi efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy AT federicapignatti efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy AT susannaricci efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy AT giorgiavitali efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy AT nicolastefanelli efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy AT elisaassirelli efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy AT simonaneri efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy AT susannanaldi efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy AT cesarefaldini efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy AT cesarefaldini efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy AT francescoursini efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy AT francescoursini efficacysafetyandtolerabilityofverylowcalorieketogenicdietinobesewomenwithfibromyalgiaapilotinterventionalstudy |