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NCT Number: NCT06164860

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

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).

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Key information

Conditions

Obesity and Psoriasis Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Psoriasis Signs and Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vaia Lambadiari

Athens, Attica, 12462, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age above 18 years
  • body mass index (BMI) >30 kg/m2
  • 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.
  • ΔPASI SCORE<75, with moderate or severe activity in joints ( > 3 swollen &> 3 tender joints ή DAPSA< 14).

Exclusion criteria

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

Treatment and study plan

Meditteranean Diet

Other

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

Ketogenic diet

Other

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.

Primary outcomes

  1. Psoriasis Area and Severity Index score

    Time frame: eight weeks

    The primary endpoint is changes in Psoriasis Area and Severity Index (PASI), 8 weeks after each diet intervention.(score range: 0-72; higher scores indicate more severe disease).

  2. Disease Activity Index for Psoriatic Arthritis score

    Time frame: eight weeks

    The primary endpoint is changes in Disease Activity Index for Psoriatic Arthritis (DAPSA) score, 8 weeks after each diet intervention.(DAPSA<4: remission, DAPSA 4-14: low disease activity, DAPSA:14-28:moderate disease activity, DAPSA>28: high disease activity)

Secondary outcomes

  1. Interleukin-6

    Time frame: eight weeks

    Secondary endpoints were biochemical markers of inflammation (IL-6) 8 weeks after KD compared to 8-weeks MD diet intervention.

  2. Interleukin-17

    Time frame: eight weeks

    Secondary endpoints were biochemical markers of inflammation (IL-17) 8 weeks after KD compared to 8-weeks MD diet intervention.

  3. Interleukin-22

    Time frame: eight weeks

    Secondary endpoints were biochemical markers of inflammation (IL-22) 8 weeks after KD compared to 8-weeks MD diet intervention.

  4. Interleukin-23

    Time frame: eight weeks

    Secondary endpoints were biochemical markers of inflammation (IL-23) 8 weeks after KD compared to 8-weeks MD diet intervention.

  5. Glucagon Like Peptide-1

    Time frame: eight weeks

    The investigators assessed changes in Glucagon Like Peptide-1 levels 8-weeks after KD compared to 8-weeks MD diet intervention.

  6. Oxyntomodulin

    Time frame: eight weeks

    The investigators assessed changes in Oxyntomodulin levels 8-weeks after KD compared to 8-weeks MD diet intervention.

  7. Peptide YY

    Time frame: eight weeks

    The investigators assessed changes in Peptide YY levels 8-weeks after KD compared to 8-weeks MD diet intervention.

  8. Ghrelin

    Time frame: eight weeks

    The investigators assessed changes in Ghrelin levels 8-weeks after KD compared to 8-weeks MD diet intervention.

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Dec 11, 2023
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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