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Adult patients with fibromyalgia or symptomatic knee osteoarthritis and comorbid obesity eligible to a very low calories ketogenic diet will be enrolled in the pilot study
the study will be conducted following different periods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic knee osteoarthritis | Other | obese patients with symptomatic knee osteoarthritis eligible to a very low calories ketogenic diet |
|
| obese patients with fibromyalgia | Other | obese patients with with fibromyalgia eligible to a very low calories ketogenic diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very low-calorie ketogenic diet for patients with symptomatic knee osteoarthritis | Dietary Supplement | A personalized very low-calorie ketogenic diet will be prepared for each patient by specialized dietitians using a combination of commercially-available ketogenic preparations and patient's handmade prepared meals |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy of the very low-calorie ketogenic diet in patient with fibromyalgia | change in Fibromyalgia Impact Questionnaire total score for fibromyalgia | baseline, 8 weeks and 20 weeks |
| efficacy of the very low-calorie ketogenic diet in patient with osteoarthritis | change in Western Ontario total score for osteoarthritis | baseline, 8 weeks and 20 weeks |
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Inclusion Criteria:
BMI ≥ 35 kg/m2 Past diagnosis of type 2 diabetes without β-cell failure Hypertriglyceridemia (fasting triglycerides ≥ 150 mg/dL) or taking lipid-lowering medications Hypercholesterolemia (total cholesterol > 200 mg/dL) or taking lipid-lowering medications Past diagnosis of arterial hypertension or taking blood pressure-lowering medications Past diagnosis of non-alcoholic fatty liver disease Past diagnosis of heart failure class NYHA I-II Past history of myocardial infarction (> 12 months), stroke/minor stroke (> 12 months) Past diagnosis of carotid atherosclerosis Past diagnosis of polycystic ovary syndrome (PCOS) Past diagnosis of neurodegenerative disorders
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39408203 | Derived | Ciaffi J, Mancarella L, Pederzani G, Lisi L, Brusi V, Pignatti F, Ricci S, Vitali G, Faldini C, Ursini F. Efficacy, Safety, and Tolerability of a Very Low-Calorie Ketogenic Diet in Women with Obesity and Symptomatic Knee Osteoarthritis: A Pilot Interventional Study. Nutrients. 2024 Sep 24;16(19):3236. doi: 10.3390/nu16193236. | |
| 37502721 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 22, 2021 | Apr 13, 2023 |
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|
| Very low-calorie ketogenic diet for patients with fibromyalgia | Dietary Supplement | A personalized very low-calorie ketogenic diet will be prepared for each patient by specialized dietitians using a combination of commercially-available ketogenic preparations and patient's handmade prepared meals |
|
| Ciaffi J, Lisi L, Mari A, Mancarella L, Brusi V, Pignatti F, Ricci S, Vitali G, Stefanelli N, Assirelli E, Neri S, Naldi S, Faldini C, Ursini F. Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study. Front Nutr. 2023 Jul 12;10:1219321. doi: 10.3389/fnut.2023.1219321. eCollection 2023. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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