Low-Salt Diet Effect on Th17-Mediated Inflammation and Vascular Reactivity in Psoriasis

Effects of Low Salt Dietary Intake on Th17-Mediated Inflammation and Vascular Reactivity in Patients With Psoriasis

Psoriasis presents an independent cardiovascular risk factor characterized by chronic low-grade systemic inflammation and oxidative stress which altogether might lead to endothelial dysfunction. It has been reported that increased oxidative stress has a pivotal role in high dietary sodium-induced endothelial dysfunction. Previous studies on sodium accumulation in psoriatic skin lesions and the sodium-induced augmentation in Th17 immune response, raise the question on the complex interplay between sodium and psoriasis, especially in the context of cardiovascular morbidity.

This study aimed to investigate the effect of a 2-week low-salt diet on endothelium-dependent and endothelium-independent cutaneous microvascular vasodilation and Th17-Mediated Inflammation in patients with psoriasis vulgaris.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Other: Low-Salt Diet

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ines Drenjančević, MD, PhD; Phone Number: +38531512800; Email: ines.drenjancevic@mefos.hr

Study Locations

• Croatia
  • Osijek, Croatia, 31000
    • Recruiting
    • University Hospital Osijek
    • Contact: Martina Mihalj, MD, PhD; Phone Number: +385 31 512 426; Email: martina.mihalj@gmail.com
    • Contact: Ivana Krajina, MD; Email: krajina.ivana91@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients with diagnosed psoriasis vulgaris
• subjects do not use topical corticosteroid therapy for at least 2 weeks before inclusion in the study and 2 weeks during the study
• subjects do not use systemic or biological therapy for at least 3 months before and 2 weeks during the study.

Exclusion Criteria:

• age < 18 years
• existence of other immune-mediated diseases (with the exception of autoimmune thyroid diseases and psoriatic arthritis - people with these comorbidities can be included)
• malignant diseases
• current infectious diseases and allergic reactions within 6 weeks before the start of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-Salt Diet; Low-salt diet (LS diet) according to DASH eating plan, with sodium intake of 1500 mg (3.75 g of salt), within the period of 14 days	Other: Low-Salt Diet; Low-salt diet (LS diet) according to DASH eating plan, with sodium intake of 1500 mg (3.75 g of salt), within the period of 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microvascular endothelial function	Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperaemia - PORH), in response to iontophoresis of acetylcholine (ACh) and local thermal hyperemia (LTH) before and after LS diet protocol	2 weeks
Frequency of peripheral T helper 17 (Th17) and regulatory lymphocytes (Treg) among parent lymphocytes sub-population	Flow cytometry assessment of the frequencies of peripheral Treg and Th17 lymphocytes before and after LS diet protocol	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microvascular non-endothelial function	Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to iontophoresis of sodium nitroprusside (SNP) before and after LS diet protocol	2 weeks
24-hour natriuresis	A 24-h urinary sodium excretion will be measured in each participant before and after LS diet protocol in order to assess compliance to the given dietary protocol	2 weeks
Relative amount of serum- and glucocorticoid-induced kinase 1 (SGK1) in peripheral blood mononuclear cells	Relative amount of total serum- and glucocorticoid regulated kinase 1 (SGK1) in cultured cells will be measured by commercially available cell-based enzyme-linked immuno-sorbent assay (ELISA) kit before and after LS diet protocol	2 weeks
Serum Protein Concentration of Pro- and Anti-Inflammatory Cytokines	Serum protein concentrations (pg/mL) of pro-inflammatory and anti-inflammatory cytokines will be measured with panel for multiplex protein quantitation before and after LS diet protocol	2 weeks

Collaborators and Investigators

• Sponsor: Josip Juraj Strossmayer University of Osijek

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: May 27, 2023
• First Submitted That Met QC Criteria: May 27, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Psoriasis; Laser-Doppler Flowmetry; Microcirculation; Endothelium; Diet, Sodium-Restricted
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Diseases, Papulosquamous; Inflammation; Psoriasis
• Other Study ID Numbers: 215861462341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No