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

Knee Osteoarthritis Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial Description

the study will be conducted following different periods:

1. 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.

2. 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.

3. Maintenance (for 12 weeks). After very low calories ketogenic diet phase, the patient will start maintenance period as described ;

Related Conditions & MeSH terms

• Fibromyalgia
• Knee Osteoarthritis
• Myofascial Pain Syndromes
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT05848544
• Study type: Interventional
• Source: Istituto Ortopedico Rizzoli
• Contact: Francesco Ursini, MD
• Phone: 0039051.63.66
• Email: francesco.ursini@ior.it
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2021
• Completion date: December 31, 2024