NCT06164860

The Effect of Ketogenic Diet Versus Mediterranean Diet in Patients With Obesity and Psoriatic Arthritis

The Effect of Ketogenic Diet Versus Mediterranean Diet on Clinical and Biochemical Markers of Inflammationand in Patients With Obesity and Psoriatic Arthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Attikon Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of our study is to compare the effectiveness of Mediterranean diet (MD) with the isocaloric Ketogenic diet (KD) on clinical and biochemical markers of inflammation in patients with obesity, psoriasis (PSO) and psoriatic arthritis (PsA).

Detailed description

Overall, twenty patients with body mass index (BMI) \>30 kg/m2, PSO and PsA under constant systematic treatment for at least 3 months will be included in the study. They will randomly assign to two groups, starting either with MD or KD for a period of 8 weeks. After a 6-week washout interval, the two groups will cross over to the other type of diet for the same 8-week period. The primary endpoint is the change in Psoriasis Area and Severity Index (PASI) and the Disease Activity Index for Psoriatic Arthritis (DAPSA) score, 8 weeks after each diet intervention. Secondary endpoints are changes in biochemical markers of inflammation (IL-6, IL-17, IL-22, IL-23) , in metabolic and anthropometric parameters.

Conditions

• Obesity and Psoriasis

Interventions

Type	Name	Description
OTHER	Meditteranean Diet	The MD provided 20% proteins, 40% fat and 40% carbohydrates. Each participant received a brochure with a template of a daily five course (breakfast, lunch, dinner and two snacks) diet plan that provided several options for each meal and was advised to use it as a guide for the 8-week period
OTHER	Ketogenic Diet	The KD provided approximately 34% proteins, 55% fat and 11% carbohydrates. The macronutrient targets were successfully met by replacing breakfast and two daily snacks with specifically selected food products provided by Evivios Med. Lunch and dinner were natural protein-rich dishes. Each participant received accurate teaching and a brochure that incorporated a template of a weekly diet plan from an expert dietitian.

Timeline

• Start date: 2020-05-20
• Primary completion: 2022-01-31
• Completion: 2023-08-30
• First posted: 2023-12-11
• Last updated: 2025-11-19

Locations

1 site across 1 country: Greece