Impact of the Mediterranean Diet on Patients With Psoriasis

Obesity Clinical Trial

— MEDIPSO  

Official title:

Impact of the Mediterranean Diet on Patients With Psoriasis: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257641
• Other study ID #: MEDIPSO
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: Javier Pérez Bootello
• Phone: 913368247
• Email: jpbootello[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: April 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

• 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.

Related Conditions & MeSH terms

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

Intervention

Other:
• High-intensity Mediterranean diet intervention
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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in weight at week 16	Weight in kilograms will be assessed by a physician at baseline and week 16	Baseline and week 16
Secondary	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	Baseline and week 16
Secondary	Change from baseline in abdominal circumference at week 16	Abdominal circumference in centimetres will be assessed by a physician at baseline and week 16	Baseline and week 16
Secondary	Change from baseline in serum inflammatory interleukins at week 16	Change in levels of Granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon gamma (IFN?), interleukin 1ß (IL-1ß), 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/IFN?2, IL 31, IL 33/NF HEV (mature), MIP-3a/CCL20, tumoral necrosis factor alpha (TNFa) and TNFß/Lymphotoxin-a (LTA), all of them measured in pg/ml will also be assessed.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	Change from baseline in glycated haemoglobin at week 16	Change in levels of glycated haemoglobin measured in percentage (%) will also be assessed.	Baseline and week 16
Secondary	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.	Baseline and week 16
Secondary	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)	Baseline and week 16
Secondary	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)	Baseline and week 16
Secondary	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)	Baseline and week 16
Secondary	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)	Baseline and week 16