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

Primary Purpose

Psoriasis Vulgaris

Status
Recruiting
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Low-Salt Diet
Sponsored by
Josip Juraj Strossmayer University of Osijek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Diet, Sodium-Restricted, Psoriasis, Laser-Doppler Flowmetry, Microcirculation, Endothelium

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital OsijekRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low-Salt Diet

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
May 27, 2023
Last Updated
June 8, 2023
Sponsor
Josip Juraj Strossmayer University of Osijek
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1. Study Identification

Unique Protocol Identification Number
NCT05892640
Brief Title
Low-Salt Diet Effect on Th17-Mediated Inflammation and Vascular Reactivity in Psoriasis
Official Title
Effects of Low Salt Dietary Intake on Th17-Mediated Inflammation and Vascular Reactivity in Patients With Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Josip Juraj Strossmayer University of Osijek

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
Keywords
Diet, Sodium-Restricted, Psoriasis, Laser-Doppler Flowmetry, Microcirculation, Endothelium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-Salt Diet
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Low-Salt Diet
Intervention Description
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
Primary Outcome Measure Information:
Title
Microvascular endothelial function
Description
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
Time Frame
2 weeks
Title
Frequency of peripheral T helper 17 (Th17) and regulatory lymphocytes (Treg) among parent lymphocytes sub-population
Description
Flow cytometry assessment of the frequencies of peripheral Treg and Th17 lymphocytes before and after LS diet protocol
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Microvascular non-endothelial function
Description
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
Time Frame
2 weeks
Title
Relative amount of serum- and glucocorticoid-induced kinase 1 (SGK1) in peripheral blood mononuclear cells
Description
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
Time Frame
2 weeks
Title
Serum Protein Concentration of Pro- and Anti-Inflammatory Cytokines
Description
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
Time Frame
2 weeks
Title
24-hour natriuresis
Description
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
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ines Drenjančević, MD, PhD
Phone
+38531512800
Email
ines.drenjancevic@mefos.hr
Facility Information:
Facility Name
University Hospital Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Mihalj, MD, PhD
Phone
+385 31 512 426
Email
martina.mihalj@gmail.com
First Name & Middle Initial & Last Name & Degree
Ivana Krajina, MD
Email
krajina.ivana91@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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