Obesity and PsoriasisNCT06164860
The Effect of Ketogenic Diet Versus Mediterranean Diet in Patients With Obesity and Psoriatic Arthritis
A study testing Meditteranean Diet and Ketogenic Diet in people with Obesity and Psoriasis, run by Attikon Hospital at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity and Psoriasis
- What is being tested?
- Meditteranean Diet and Ketogenic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGreece
- Study dates
- 20 May 2020to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- participation in another study
- eGFR<60ml/min/1.73m2
- malignancy
- severe hepatic disorder
- HbA1C>10%
- use of glucagon-like-petide-1 analogues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Obesity and Psoriasis
- Being tested
- Meditteranean Diet, Ketogenic Diet
- Medical subject headings
- Obesity, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | started with MD Receives: Other: Meditteranean Diet; Other: Ketogenic Diet |
| Group B | Other | started with KD Receives: Other: Meditteranean Diet; Other: Ketogenic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: eight weeks
Secondary outcomes (8)
Interleukin-6
Secondary endpoints were biochemical markers of inflammation (IL-6) 8 weeks after KD compared to 8-weeks MD diet intervention.
Measured: eight weeks
Interleukin-17
Secondary endpoints were biochemical markers of inflammation (IL-17) 8 weeks after KD compared to 8-weeks MD diet intervention.
Measured: eight weeks
Interleukin-22
Secondary endpoints were biochemical markers of inflammation (IL-22) 8 weeks after KD compared to 8-weeks MD diet intervention.
Measured: eight weeks
Interleukin-23
Secondary endpoints were biochemical markers of inflammation (IL-23) 8 weeks after KD compared to 8-weeks MD diet intervention.
Measured: eight weeks
Glucagon Like Peptide-1
The investigators assessed changes in Glucagon Like Peptide-1 levels 8-weeks after KD compared to 8-weeks MD diet intervention.
Measured: eight weeks
Oxyntomodulin
The investigators assessed changes in Oxyntomodulin levels 8-weeks after KD compared to 8-weeks MD diet intervention.
Measured: eight weeks
Peptide YY
The investigators assessed changes in Peptide YY levels 8-weeks after KD compared to 8-weeks MD diet intervention.
Measured: eight weeks
Ghrelin
The investigators assessed changes in Ghrelin levels 8-weeks after KD compared to 8-weeks MD diet intervention.
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start20 May 2020
- Primary completion31 Jan 2022
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VAIA LAMBADIARI, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164860
- Sponsor's protocol ID
- 171/9-4-2020
- Status last verified
- Nov 2025
- First submitted
- 2 Dec 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ketogenic Diet Versus Mediterranean Diet on Clinical and Biochemical Markers of Inflammationand in Patients With Obesity and Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT06164860
- Acronym / sponsor ID
- 171/9-4-2020
- Conditions
- Obesity and Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Other: Meditteranean Diet, Other: Ketogenic Dietstarted with MD |
| Group B | Other | Other: Meditteranean Diet, Other: Ketogenic Dietstarted with KD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- participation in another study
- eGFR<60ml/min/1.73m2
- malignancy
- severe hepatic disorder
- HbA1C>10%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditteranean DietThe 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 | Group A, Group B |
| Ketogenic DietThe 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 A, Group B |
Primary outcome
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).
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)
8 secondary outcomes
Interleukin-6
Time frame: eight weeks
Interleukin-17
Time frame: eight weeks
Interleukin-22
Time frame: eight weeks
Interleukin-23
Time frame: eight weeks
Glucagon Like Peptide-1
Time frame: eight weeks
Oxyntomodulin
Time frame: eight weeks
Peptide YY
Time frame: eight weeks
Ghrelin
Time frame: eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditteranean Diet and Ketogenic Diet in people with Obesity and Psoriasis, run by Attikon Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index score (time frame: eight weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.