Impact of the Mediterranean Diet on Patients with Psoriasis

NCT06257641 | Completed

• 1 other identifier: MEDIPSO
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Psoriasis; Psoriasis Vulgaris; Hyperlipidemias; Depression; Anxiety; Metabolic Syndrome; Obesity

Keywords

Psoriasis; Mediterranean diet; Dietary intervention; Psoriasis vulgaris; Metabolic syndrome

Outcome Measures

Primary Outcomes (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).

  Baseline and week 16

Secondary Outcomes (12)

• Change from baseline in weight at week 16

  Baseline and week 16

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

  Baseline and week 16

• Change from baseline in abdominal circumference at week 16

  Baseline and week 16

• Change from baseline in serum inflammatory interleukins at week 16

  Baseline and week 16

• Change from baseline in serum lipids at week 16

  Baseline and week 16

Study Arms (2)

High-intensity Mediterranean diet

EXPERIMENTAL

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. 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.

Other: High-intensity Mediterranean diet intervention

Standard of care

NO INTERVENTION

Patients assigned to the control group will be provided with standard recommendations for a low-fat diet with no monitoring by nutritionists.

Interventions

High-intensity Mediterranean diet intervention OTHER

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.

High-intensity Mediterranean diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).
• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Related Publications (14)

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

  PMID: 25085957 BACKGROUND

• 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.

  PMID: 31431821 BACKGROUND

• 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.

  PMID: 32222582 BACKGROUND

• 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.

  PMID: 31547615 BACKGROUND

• 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.

  PMID: 30046840 BACKGROUND

• 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.

  PMID: 31605152 BACKGROUND

• 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.

  PMID: 25940230 BACKGROUND

• 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.

  PMID: 33284131 BACKGROUND

• 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.

  PMID: 35963333 BACKGROUND

• 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.

  PMID: 21508208 BACKGROUND

• 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.

  PMID: 34364236 BACKGROUND

• 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.

  PMID: 29897866 BACKGROUND

• 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.

  PMID: 40991259 DERIVED

• 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.

  PMID: 39879606 DERIVED

MeSH Terms

Conditions

Psoriasis; Hyperlipidemias; Depression; Anxiety Disorders; Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Javier Pérez Bootello

  Hospital Universitario Ramón y Cajal. Instituto Ramón y Cajal de Investigación Sanitaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Experimental, randomised, controlled, open-label, single-blind (outcome assessor) study.

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: February 14, 2024
• Study Start: February 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: March 10, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 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.
• Access Criteria: All the information will be open access

Locations

ES (1)