NCT05848544

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Fibromyalgia
• Knee Osteoarthritis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Very low-calorie ketogenic diet for patients with symptomatic knee osteoarthritis	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
DIETARY_SUPPLEMENT	Very low-calorie ketogenic diet for patients with fibromyalgia	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

Timeline

• Start date: 2021-04-02
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-05-08
• Last updated: 2025-03-26

Locations

1 site across 1 country: Italy