Efficacy of a Very Low Calories Ketogenic Diet in Obese Patients With Fibromyalgia or Symptomatic Knee Osteoarthritis

NCT05848544 | Completed

• 1 other identifier: KD-FM-OA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibromyalgia; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Symptomatic knee osteoarthritis

OTHER

obese patients with symptomatic knee osteoarthritis eligible to a very low calories ketogenic diet

Dietary Supplement: Very low-calorie ketogenic diet for patients with symptomatic knee osteoarthritis

obese patients with fibromyalgia

OTHER

obese patients with with fibromyalgia eligible to a very low calories ketogenic diet

Dietary Supplement: Very low-calorie ketogenic diet for patients with fibromyalgia

Interventions

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

Symptomatic knee osteoarthritis

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

obese patients with fibromyalgia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years and \< 65 years
• Body mass index ≥ 30 kg/m2
• Failed to achieve weight loss with standard low-calories diet
• Any of the following conditions:
• 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
• Fibromyalgia classified according to 2016 Revisions to the 2010/2011 European League Against Rheumatism/ American College of Rheumatology OR
• Symptomatic knee osteoarthritis

You may not qualify if:

• Age \< 18 or \> 65 years
• Currently pregnant or breastfeeding
• Past diagnosis of type 1 diabetes mellitus, latent autoimmune diabetes in adults, β-cell failure in type 2 diabetes mellitus, use of sodium/glucose cotransporter 2 inhibitors (risk for euglycemic diabetic ketoacidosis)
• Past diagnosis of kidney failure and moderate-to-severe chronic kidney disease, liver failure, hearth failure NYHA III-IV, respiratory failure
• Past diagnosis of unstable angina
• Recent stroke or myocardial infarction (\< 12 months)
• Cardiac arrhythmias
• Past diagnosis of eating disorders and other severe mental illnesses, alcohol and substance abuse
• Active/severe infections
• h prior to elective surgery or invasive procedures and perioperative period
• Past diagnosis of rare disorders: porphyria, carnitine deficiency, carnitine palmitoyltransferase deficiency, carnitine-acylcarnitine translocase deficiency, mitochondrial fatty acid β-oxidation disorders, pyruvate carboxylase deficiency
• Allergy to protein-preparations ingredients
• Past or current history of gallstones

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (2)

• 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.

  PMID: 39408203 DERIVED

• 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.

  PMID: 37502721 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Osteoarthritis; Arthritis; Joint Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 8, 2023
• Study Start: April 2, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

IT (1)