NCT06164860

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

December 2, 2023

Last Update Submit

November 15, 2025

Conditions

Obesity and Psoriasis

Outcome Measures

Primary Outcomes (2)

  • Psoriasis Area and Severity Index score

    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).

    eight weeks

  • Disease Activity Index for Psoriatic Arthritis score

    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)

    eight weeks

Secondary Outcomes (8)

  • Interleukin-6

    eight weeks

  • Interleukin-17

    eight weeks

  • Interleukin-22

    eight weeks

  • Interleukin-23

    eight weeks

  • Glucagon Like Peptide-1

    eight weeks

  • +3 more secondary outcomes

Study Arms (2)

Group A

OTHER

started with MD

Other: Meditteranean DietOther: Ketogenic Diet

Group B

OTHER

started with KD

Other: Meditteranean DietOther: Ketogenic Diet

Interventions

Meditteranean DietOTHER

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

Group AGroup B
Ketogenic DietOTHER

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.

Group AGroup B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vaia Lambadiari

Athens, Attica, 12462, Greece

Location

MeSH Terms

Conditions

ObesityPsoriasis

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine-Endocrinology

Study Record Dates

First Submitted

December 2, 2023

First Posted

December 11, 2023

Study Start

May 20, 2020

Primary Completion

January 31, 2022

Study Completion

August 30, 2023

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

GR(1)