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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity and Psoriasis
• Intervention / Treatment: Other: Meditteranean Diet; Other: Ketogenic Diet

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 12462
      • Vaia Lambadiari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A; started with MD	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.
Other: Group B; started with KD	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukins	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.	eight weeks

Collaborators and Investigators

• Sponsor: Attikon Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): January 31, 2022
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: December 2, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Joint Diseases; Musculoskeletal Diseases; Arthritis; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Obesity; Psoriasis; Arthritis, Psoriatic
• Other Study ID Numbers: 312/01-05-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No