NCT05848544Completed
Efficacy of a Very Low Calories Ketogenic Diet in Obese Patients With Fibromyalgia or Symptomatic Knee Osteoarthritis
Source: ClinicalTrials.gov · Last updated 26 Mar 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 13 Apr 2023
- Start date
- 2 Apr 2021
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Diseases
- Obesity
- NCT number
- NCT05848544
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 2 Apr 2021 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 48 h prior to elective surgery or invasive procedures and perioperative period
Other illness
- 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
- 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
Lab values
- 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)
Age
- Age \< 18 or \> 65 years
Other
- Currently pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Istituto ortopedico Rizzoli Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
Related publications
- 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 · PMID 39408203
- Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study.Front Nutr · 2023 · PMID 37502721
This page is information, not medical advice. Discuss any trial with your doctor.