Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257641
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-01-21
Brief Title:
Impact of the Mediterranean Diet on Patients With Psoriasis
Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Organization:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study Overview
Official Title:
Impact of the Mediterranean Diet on Patients With Psoriasis a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEDIPSO
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None