Efficacy of a Very Low Calories Ketogenic Diet in Obese Patients With Fibromyalgia or Symptomatic Knee Osteoarthritis (KD-FM-OA)

Istituto Ortopedico Rizzoli

Status

Enrolling

Conditions

Fibromyalgia

Knee Osteoarthritis

Treatments

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

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05848544

KD-FM-OA

Details and patient eligibility

About

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

Full description

the study will be conducted following different periods:

Free diet (for 4 weeks). After recruitment, the patient will enter "free diet phase" in which he/she will be asked to follow a normal free diet for 4 weeks. During this period, a nutritional interview will be carried out by a trained dietician who will elaborate a personalized diet and order the ketogenic products on the basis of patient's preferences.
very low calories ketogenic diet (for 8 weeks). After the free diet period, the patient will start the very low calories ketogenic regimen. At the beginning of this period a box with the commercial products necessary to cover the whole study period will be hand-delivered by a dietician that will instruct the patient on the correct use and storage.
Maintenance (for 12 weeks). After very low calories ketogenic diet phase, the patient will start maintenance period as described

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
48 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