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

Phase 4

Active, not recruiting

• Conditions: Obesity and Psoriasis
• Interventions: Other: Meditteranean Diet; Other: Ketogenic Diet

• Registration Number: NCT06164860
• Lead Sponsor: Attikon Hospital

Brief 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.

Study Timeline

• Study Start: 2020-05-20
• Primary Completion: 2022-01-31
• Status Verified: 2023-12
• Study First Submitted: 2023-12-02
• Study First Submitted QC: 2023-12-08
• Last Update Submitted: 2023-12-08
• Study First Posted: 2023-12-11
• Last Update Posted: 2023-12-11
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. age above 18 years
2. body mass index (BMI) >30 kg/m2
3. diagnosis of psoriasis and psoriatic arthritis under constant systematic treatment with biologic agents and/or synthetic disease-modifying anti-rheumatic drugs (DMARDs) for at least 3 months.
4. ΔPASI SCORE<75, with moderate or severe activity in joints ( > 3 swollen &> 3 tender joints ή DAPSA< 14).

Exclusion Criteria

1. participation in another study
2. eGFR<60ml/min/1.73m2
3. malignancy
4. severe hepatic disorder
5. HbA1C>10%
6. use of glucagon-like-petide-1 analogues

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	Ketogenic Diet	started with KD
Group B	Meditteranean Diet	started with KD
Group A	Ketogenic Diet	started with MD
Group A	Meditteranean Diet	started with MD

Primary Outcome Measures

Name	Time	Method
DAPSA score	eight weeks	The primary endpoint is changes in Disease Activity Index for Psoriatic Arthritis (DAPSA) score, 8 weeks after each diet intervention.
PASI score	eight weeks	The primary endpoint is changes in Psoriasis Area and Severity Index (PASI), 8 weeks after each diet intervention.

Secondary Outcome Measures

Name	Time	Method
Interleukins	eight weeks	Secondary endpoints were biochemical markers of inflammation (IL-6, IL-17, IL-22, IL-23) 8 weeks after KD compared to 8-weeks MD diet intervention.

Trial Locations

Locations (1)

Vaia Lambadiari; 🇬🇷 Athens, Attiki, Greece