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

• Sponsor: Josip Juraj Strossmayer University of Osijek (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05892640
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 21.9
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Other: Low-Salt Diet	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Low Salt Dietary Intake on Th17-Mediated Inflammation and Vascular Reactivity in Patients With Psoriasis
• Actual Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Microvascular endothelial function [2 weeks]

   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. Frequency of peripheral T helper 17 (Th17) and regulatory lymphocytes (Treg) among parent lymphocytes sub-population [2 weeks]

   Flow cytometry assessment of the frequencies of peripheral Treg and Th17 lymphocytes before and after LS diet protocol

Secondary Outcome Measures

1. Microvascular non-endothelial function [2 weeks]

   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. Relative amount of serum- and glucocorticoid-induced kinase 1 (SGK1) in peripheral blood mononuclear cells [2 weeks]

   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

3. Serum Protein Concentration of Pro- and Anti-Inflammatory Cytokines [2 weeks]

   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

4. 24-hour natriuresis [2 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Osijek	Osijek		Croatia	31000

Sponsors and Collaborators

• Josip Juraj Strossmayer University of Osijek

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ines Drenjancevic, Vice Dean for Science, Faculty of Medicine Josip Juraj Strossmayer University of Osijek, Josip Juraj Strossmayer University of Osijek
• ClinicalTrials.gov Identifier: NCT05892640
• Other Study ID Numbers: 215861462341
• First Posted: Jun 7, 2023
• Last Update Posted: Jun 9, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ines Drenjancevic, Vice Dean for Science, Faculty of Medicine Josip Juraj Strossmayer University of Osijek, Josip Juraj Strossmayer University of Osijek: Diet, Sodium-Restricted; Psoriasis; Laser-Doppler Flowmetry; Microcirculation; Endothelium
• Additional relevant MeSH terms: Psoriasis; Inflammation

Study Results

No Results Posted as of Jun 9, 2023