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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 27, 2023
CompletedFirst Posted
Study publicly available on registry
June 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJune 9, 2023
June 1, 2023
1.3 years
May 27, 2023
June 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Microvascular non-endothelial function
2 weeks
Relative amount of serum- and glucocorticoid-induced kinase 1 (SGK1) in peripheral blood mononuclear cells
2 weeks
Serum Protein Concentration of Pro- and Anti-Inflammatory Cytokines
2 weeks
24-hour natriuresis
2 weeks
Study Arms (1)
Low-Salt Diet
EXPERIMENTALLow-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
Interventions
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
Eligibility Criteria
You may qualify if:
- patients with diagnosed psoriasis vulgaris
- subjects do not use systemic or biological therapy for at least 3 months before and 2 weeks during the study.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Osijek
Osijek, 31000, Croatia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Dean for Science, Faculty of Medicine Josip Juraj Strossmayer University of Osijek
Study Record Dates
First Submitted
May 27, 2023
First Posted
June 7, 2023
Study Start
September 1, 2022
Primary Completion
December 31, 2023
Study Completion
June 30, 2024
Last Updated
June 9, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share