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

Attikon University Hospital

Status and phase: Active, not recruiting; Phase 4

Conditions: Obesity and Psoriasis

Treatments: Other: Ketogenic Diet; Other: Meditteranean Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06164860

312/01-05-2020

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Group A

Other group

Description:

started with MD

Treatment:

Other: Ketogenic Diet

Other: Meditteranean Diet

Group B

Other group

Description:

started with KD

Treatment:

Other: Ketogenic Diet

Other: Meditteranean Diet