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PsoriasisMEDIPSONCT06257641

Impact of the Mediterranean Diet on Patients with Psoriasis

A study testing High-intensity Mediterranean diet intervention in people with Psoriasis and Psoriasis Vulgaris, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to determine the effect of a high-intensity Mediterranean diet intervention over 16 weeks in a group of patients with mild to moderate psoriasis in terms of skin improvement as measured by PASI. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Psoriasis, Psoriasis Vulgaris, Hyperlipidemias
What is being tested?
High-intensity Mediterranean diet intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteSpain
Study dates
15 Feb 2024to 10 Mar 2025
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Psoriasis clinically diagnosed by a dermatologist.
  • Predominantly psoriasis vulgaris.
  • Psoriasis Area and Severity Index (PASI) ≥2 and ≤ 10 at the time of recruitment.
  • Stable weight (< 5% weight loss or gain) in the last 3 months.
  • Treated exclusively with topical treatment for psoriasis at enrolment and throughout the study.
  • Able to give informed consent.
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  • Willing and able to follow the study procedure.
  • Willing and able to attend all scheduled visits during the study period.
  • Willing and able to provide blood samples as indicated in the procedure.
  • Willing to implement pregnancy prevention measures throughout the study period.

Who cannot join

  • Type 1 or 2 diabetes mellitus.
  • Good adherence to the Mediterranean diet at the time of screening (er-MEDAS ≥8).
  • Language barrier (patients not fluent in Spanish or English).
  • Conditions that make telephone communication difficult (e.g. severe hearing loss).
  • History of cardiac disease(s).
  • Comorbidities that may compromise the implementation of the intervention (e.g. cancer, digestive diseases...) or limit survival to less than 6 months.
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  • History or current eating disorder (anorexia, bulimia, etc.; screening will be carried out using the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, if indicated).
  • Malnourished patients (screening using the Malnutrition Universal Screening Tool -MUST-, if indicated).
  • Presenting gout.
  • Pregnant, planning pregnancy or breastfeeding.
  • Use of diuretics at the time of sampling.
  • BMI greater than 40 kg/m2.
  • Difficulty or inconvenience in changing dietary habits and following the Mediterranean diet (allergies, food intolerances, special diets).
  • Participation in a clinical trial with drugs or dietary intervention in the year prior to inclusion in this study.
  • Patients who during the recruitment period are expected to have poor collaboration, lack of commitment or real difficulties in following the development of the study.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034

Other trials in Spain

About this study

Official title: Impact of the Mediterranean Diet on Patients with Psoriasis: a Randomized Clinical Trial

The goal of this clinical trial is to determine the effect of a high-intensity Mediterranean diet intervention over 16 weeks in a group of patients with mild to moderate psoriasis in terms of skin improvement as measured by PASI. In addition, the aim of this study will be to gather the necessary information for a larger and more extended clinical trial in the future.

Participants will be provided with dietary education for the implementation of the Mediterranean diet, supported by a monthly follow-up by nutritionists with experience in the field. Researchers will compare the effect of the Mediterranean diet on these patients to a control group provided with standard recommendations for a low-fat diet with no monitoring by nutritionists.

Read the detailed description

MEDIPSO is an experimental, randomised, controlled, open-label, single-blinded (evaluator) study. It is a clinical trial in which patients with mild to moderate psoriasis with stable topical treatment are randomly assigned to either the control group or the intervention group. Patients assigned to the intervention group will undergo dietary education for the adoption of the Mediterranean diet, with monthly monitoring - mostly online - by nutritionists with experience in the field. In both groups, blood tests with metabolic parameters will be obtained before and after the study period, and data of anthropometric characteristics and quality of life will be assessed. The effect of the intervention on skin involvement, metabolic parameters and inflammatory cytokines will be assessed, and the emotional and quality of life impact will also be investigated. In addition, a methodological analysis will be carried out in order to improve the design for a larger scale clinical trial in the future.

Being tested
High-intensity Mediterranean diet intervention
Keywords
Psoriasis, Mediterranean diet, Dietary intervention, Psoriasis vulgaris, Metabolic syndrome
Medical subject headings
Psoriasis, Hyperlipidemias, Depression, Anxiety Disorders, Metabolic Syndrome, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-intensity Mediterranean diet interventionOther

    Dietary education for the adoption of the Mediterranean diet, with monthly monitoring - mostly online - by nutritionists with experience in the field. Patients will be given 500 ml of extra virgin olive oil per week and informative material about the Mediterranean diet, as well as recipes and weekly menus.

Study groups in NCT06257641
Study groupRoleWhat they receive
High-intensity Mediterranean dietExperimentalPatients assigned to the intervention group will undergo dietary education for the adoption of the Mediterranean diet, with monthly monitoring - mostly online - by nutritionists with experience in the field. Patients will be given 500 ml of extra virgin olive oil per week and informative material about the Mediterranean diet, as well as recipes and weekly menus.
Receives: Other: High-intensity Mediterranean diet intervention
Standard of careNo interventionPatients assigned to the control group will be provided with standard recommendations for a low-fat diet with no monitoring by nutritionists.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the Psoriasis Area and Severity Index (PASI) at week 16

    The Psoriasis Area Severity Index (PASI) is the most widely used scale for assessing the severity of psoriasis and for therapeutic decision making. It ranges from 0 (no lesions) to 72 (worst possible lesions throughout all body surface).

    Measured: Baseline and week 16

Secondary outcomes (12)

  1. Change from baseline in weight at week 16

    Weight in kilograms will be assessed by a physician at baseline and week 16

    Measured: Baseline and week 16

  2. Change from baseline in body mass index (BMI) at week 16

    BMI in kg/m^2 will be assessed by a physician at baseline and week 16

    Measured: Baseline and week 16

  3. Change from baseline in abdominal circumference at week 16

    Abdominal circumference in centimetres will be assessed by a physician at baseline and week 16

    Measured: Baseline and week 16

  4. Change from baseline in serum inflammatory interleukins at week 16

    Change in levels of Granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon gamma (IFNγ), interleukin 1β (IL-1β), IL 2, IL 4, IL 5, IL 6, IL 9, IL 10, IL 12 (p70), IL 13, IL 15, IL 17A/CTLA8, IL-17E/ IL-25, IL 17F, IL 21, IL 22, IL 23, IL 27, IL 28A/IFNλ2, IL 31, IL 33/NF HEV (mature), MIP-3α/CCL20, tumoral necrosis factor alpha (TNFα) and TNFβ/Lymphotoxin-α (LTA), all of them measured in pg/ml will also be assessed.

    Measured: Baseline and week 16

  5. Change from baseline in serum lipids at week 16

    Change in levels of serum cholesterol, low-density lipoproteins (LDL), high-density lipoproteins (HDL), lipoprotein A, apolipoprotein A1, apolipoprotein B1 measured in mg/dl will also be assessed.

    Measured: Baseline and week 16

  6. Change from baseline in fasting serum insulin levels at week 16

    Change in levels of fasting serum insulin levels measured in µUl/ml will also be assessed.

    Measured: Baseline and week 16

  7. Change from baseline in glycated haemoglobin at week 16

    Change in levels of glycated haemoglobin measured in percentage (%) will also be assessed.

    Measured: Baseline and week 16

  8. Change from baseline in C reactive protein at week 16

    Change in levels of C reactive protein measured in mg/L will also be assessed.

    Measured: Baseline and week 16

  9. Change from baseline in adherence to mediterranean diet at week 16

    Change in adherence to mediterranean diet will be assessed by the validated questionnaire energy-restricted Mediterranean Diet Adherence Screener (er-MEDAS), which ranges from 0 to 17 (higher score means better adherence to Mediterranean diet)

    Measured: Baseline and week 16

  10. Change from baseline in quality of life at week 16

    Change in quality of life will be assessed by the validated questionnaire Dermatology Life Quality Index (DLQI), which ranges from 0 to 30 (higher score means worse quality of life)

    Measured: Baseline and week 16

  11. Change from baseline in quality of sleep at week 16

    Change in quality of sleep will be assessed by the validated questionnaire Insomnia Severity Index (ISI), which ranges from 0 to 28 (higher score means more severe insomnia)

    Measured: Baseline and week 16

  12. Change from baseline in emotional state at week 16

    Change in emotional state will be assessed by the validated questionnaire Hospital Anxiety and Depression Scale (HADS). It consists of two sub-scales for Anxiety and Depression, both of which range from 0 to 21 (higher score means more severe anxiety/depression symptoms)

    Measured: Baseline and week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2024
  2. Study start15 Feb 2024
  3. Primary completion15 Jan 2025
  4. Study completion10 Mar 2025

Resources

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
Parallel groups
Model description
Experimental, randomised, controlled, open-label, single-blind (outcome assessor) study.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06257641
Sponsor's protocol ID
MEDIPSO
Acronym
MEDIPSO
Status last verified
Mar 2025
First submitted
21 Jan 2024
Last updated
21 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The study protocol will be published as soon as possible, and the overall results will be published when the study finishes and all data is collected.

Publications

  • Di Meglio P, Villanova F, Nestle FO. Psoriasis. Cold Spring Harb Perspect Med. 2014 Aug 1;4(8):a015354. doi: 10.1101/cshperspect.a015354.

    PubMed 25085957

  • Kocic H, Damiani G, Stamenkovic B, Tirant M, Jovic A, Tiodorovic D, Peris K. Dietary compounds as potential modulators of microRNA expression in psoriasis. Ther Adv Chronic Dis. 2019 Aug 7;10:2040622319864805. doi: 10.1177/2040622319864805. eCollection 2019.

    PubMed 31431821

  • Castaldo G, Rastrelli L, Galdo G, Molettieri P, Rotondi Aufiero F, Cereda E. Aggressive weight-loss program with a ketogenic induction phase for the treatment of chronic plaque psoriasis: A proof-of-concept, single-arm, open-label clinical trial. Nutrition. 2020 Jun;74:110757. doi: 10.1016/j.nut.2020.110757. Epub 2020 Feb 5.

    PubMed 32222582

  • Tuttolomondo A, Simonetta I, Daidone M, Mogavero A, Ortello A, Pinto A. Metabolic and Vascular Effect of the Mediterranean Diet. Int J Mol Sci. 2019 Sep 23;20(19):4716. doi: 10.3390/ijms20194716.

    PubMed 31547615

  • Phan C, Touvier M, Kesse-Guyot E, Adjibade M, Hercberg S, Wolkenstein P, Chosidow O, Ezzedine K, Sbidian E. Association Between Mediterranean Anti-inflammatory Dietary Profile and Severity of Psoriasis: Results From the NutriNet-Sante Cohort. JAMA Dermatol. 2018 Sep 1;154(9):1017-1024. doi: 10.1001/jamadermatol.2018.2127.

    PubMed 30046840

  • Caso F, Navarini L, Carubbi F, Picchianti-Diamanti A, Chimenti MS, Tasso M, Currado D, Ruscitti P, Ciccozzi M, Annarumma A, Lagana B, Perricone R, Afeltra A, Giacomelli R, Scarpa R, Costa L. Mediterranean diet and Psoriatic Arthritis activity: a multicenter cross-sectional study. Rheumatol Int. 2020 Jun;40(6):951-958. doi: 10.1007/s00296-019-04458-7. Epub 2019 Oct 11.

    PubMed 31605152

  • Martinez-Gonzalez MA, Salas-Salvado J, Estruch R, Corella D, Fito M, Ros E; PREDIMED INVESTIGATORS. Benefits of the Mediterranean Diet: Insights From the PREDIMED Study. Prog Cardiovasc Dis. 2015 Jul-Aug;58(1):50-60. doi: 10.1016/j.pcad.2015.04.003. Epub 2015 May 1.

    PubMed 25940230

  • Goni L, de la O V, Barrio-Lopez MT, Ramos P, Tercedor L, Ibanez-Criado JL, Castellanos E, Ibanez Criado A, Macias Ruiz R, Garcia-Bolao I, Almendral J, Martinez-Gonzalez MA, Ruiz-Canela M. A Remote Nutritional Intervention to Change the Dietary Habits of Patients Undergoing Ablation of Atrial Fibrillation: Randomized Controlled Trial. J Med Internet Res. 2020 Dec 7;22(12):e21436. doi: 10.2196/21436.

    PubMed 33284131

  • Berna-Rico E, Fernandez-Nieto D, Gonzalez-Cantero A. RF - Role of the Mediterranean Diet in the Treatment of Psoriasis. Actas Dermosifiliogr. 2023 Feb;114(2):152-155. doi: 10.1016/j.ad.2021.11.011. Epub 2022 Aug 10. No abstract available. English, Spanish.

    PubMed 35963333

  • Schroder H, Fito M, Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Lamuela-Raventos R, Ros E, Salaverria I, Fiol M, Lapetra J, Vinyoles E, Gomez-Gracia E, Lahoz C, Serra-Majem L, Pinto X, Ruiz-Gutierrez V, Covas MI. A short screener is valid for assessing Mediterranean diet adherence among older Spanish men and women. J Nutr. 2011 Jun;141(6):1140-5. doi: 10.3945/jn.110.135566. Epub 2011 Apr 20.

    PubMed 21508208

  • Schroder H, Zomeno MD, Martinez-Gonzalez MA, Salas-Salvado J, Corella D, Vioque J, Romaguera D, Martinez JA, Tinahones FJ, Miranda JL, Estruch R, Bueno-Cavanillas A, Alonso Gomez AM, Tur JA, Warnberg J, Serra-Majem L, Martin V, Vazquez C, Lapetra J, Pinto X, Vidal J, Daimiel L, Gaforio JJ, Matia-Martin P, Ros E, Lassale C, Ruiz-Canela M, Babio N, Sorli JV, Garcia-Arellano A, Diaz-Lopez A, Fito M, Castaner O; PREDIMED-Plus investigators. Validity of the energy-restricted Mediterranean Diet Adherence Screener. Clin Nutr. 2021 Aug;40(8):4971-4979. doi: 10.1016/j.clnu.2021.06.030. Epub 2021 Jul 6.

    PubMed 34364236

  • Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Fito M, Gea A, Hernan MA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts. N Engl J Med. 2018 Jun 21;378(25):e34. doi: 10.1056/NEJMoa1800389. Epub 2018 Jun 13.

    PubMed 29897866

  • Perez-Bootello J, Berna-Rico E, Abbad-Jaime de Aragon C, Goni L, Vazquez-Ruiz Z, Neria F, Cova-Martin R, Naharro-Rodriguez J, Ballester-Martinez A, Pindado-Ortega C, Monge D, Blauvelt A, Jaen P, Mehta N, Gelfand JM, Martinez-Gonzalez MA, Gonzalez-Cantero A. Mediterranean Diet and Patients With Psoriasis: The MEDIPSO Randomized Clinical Trial. JAMA Dermatol. 2025 Dec 1;161(12):1215-1223. doi: 10.1001/jamadermatol.2025.3410.

    PubMed 40991259

  • Perez-Bootello J, Berna-Rico E, Abbad-Jaime de Aragon C, Cova-Martin R, Goni L, Ballester-Martinez A, Jaen-Olasolo P, Mehta N, Gelfand JM, Martinez-Gonzalez MA, Gonzalez-Cantero A. Impact of the Mediterranean Diet on Patients With Psoriasis: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 29;14:e64277. doi: 10.2196/64277.

    PubMed 39879606

Questions about this trial

What is this clinical trial studying?

A study testing High-intensity Mediterranean diet intervention in people with Psoriasis and Psoriasis Vulgaris, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.

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 10 inclusion and 15 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 21 Mar 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 Spain. 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?

Change from baseline in the Psoriasis Area and Severity Index (PASI) at week 16 (time frame: Baseline and week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06257641, which also lists 14 linked publications.

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 21 Mar 2025.

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