Salt; ExcessNCT02727426
Dietary Salt and Microvascular Function
A study testing Low Salt (LS) diet and High Salt (HS) diet in people with Salt; Excess, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial summary
It is well accepted that high-salt (HS) intake is an essential risk factor in development and progression of hypertension. Results of some recent studies suggest that some of the deleterious effects of a HS diet are independent of elevated blood pressure (BP) and may occur in normotensive individuals and are… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Salt; Excess
- What is being tested?
- Low Salt (LS) diet and High Salt (HS) diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- Feb 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
Who cannot join
- oral contraceptives
- drugs that could affect the endothelium
- hypertension
- coronary artery disease
- diabetes
- hyperlipidaemia
- renal impairment
- cerebrovascular and peripheral artery disease
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology
Osijek, 31000
Ana Stupin, MD, PhD, '385915134598, anacavka@mefos.hr
Ines Drenjancevic, MD, PhD, '385912241406, ines.drenjancevic@mefos.hr
About this study
Official title: Influence of High Salt Diet on Microvascular Reactivity in Young Healthy Subjects
It is well accepted that high-salt (HS) intake is an essential risk factor in development and progression of hypertension. Results of some recent studies suggest that some of the deleterious effects of a HS diet are independent of elevated blood pressure (BP) and may occur in normotensive individuals and are associated with impaired endothelial function. However, the effects of acute salt loading on endothelial function and vascular reactivity in young healthy individuals are still scarce and inconsistent.
The purpose of present study is to determine whether one week of HS intake affects microvascular reactivity in young healthy subjects without changes in BP. In addition, the investigators sought to evaluate if potential HS diet-induced microvascular dysfunction is associated with changes in oxidative stress level and/or with modification of immunological response in young healthy subjects.
- Conditions
- Salt; Excess
- Being tested
- Low Salt (LS) diet, High Salt (HS) diet
- Keywords
- microvascular function, laser Doppler flowmetry, high salt diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Salt (LS) dietOther
Intake of less than 2.3 g of salt per day for 7 days.
High Salt (HS) dietOther
Intake of 11.2 g of salt per day for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| low salt diet | Experimental | All subjects will be instructed to maintain a low-sodium (LS) diet, with an intake of less than 2.3 g of salt per day (DASH eating plan; US Department of Health and Human Services, 2006) for 7 days (washout period). Receives: Other: Low Salt (LS) diet |
| high salt diet | Experimental | After washout period, all subjects will be instructed to maintain a high-sodium (HS) diet, with an intake of 11.2 g of salt per day for 7 days. Receives: Other: High Salt (HS) diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
microvascular reactivity
Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperemia- PORH) and in response to iontophoresis of acetylcholine (ACh) (endothelium dependent vasodilation) before and after diet protocols.
Measured: two weeks after starting the protocol
Secondary outcomes (3)
oxidative stress
As direct indicator of oxidative stress, byproducts of lipid peroxidation - TBARS method (Thiobarbituric Acid Reactive Substances) with malondialdehyde (MDA) as standard (µM MDA) will be measured before and after LS and HS diet protocol (spectrophotometric method).
Measured: two weeks after starting the protocol
modification of immunological response by high salt diet
Activated monocytes/macrophages and neutrophils will be measured by flow cytometry, with distinction of subpopulation of monocytes/macrophages (classical/nonclassical), their activation and the expression of the integrin LFA-1 (lymphocyte function-associated antigen 1) and VLA-4 (Very Late Antigen-4) - ligands VCAM-1 (vascular cell adhesion molecule 1 ) and ICAM-1 (vascular cell adhesion molecule 1).
Measured: two weeks after starting the protocol
antioxidant capacity
As an indicator of antioxidant capacity, the ferric reducing ability of plasma - the FRAP assay (Ferric reducing ability of plasma) with Trolox used as standard (mM Trolox) will be measured before and after LS and HS diet protocol (spectrophotometric method).
Measured: two weeks after starting the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Salt; ExcessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek
- Investigators
- Ines Drenjancevic, MD, PhD, Principal investigator, Faculty of Medicine, University of Osijek, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727426
- Sponsor's protocol ID
- 215861071012
- Status last verified
- Apr 2016
- First submitted
- 15 Mar 2016
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cavka A, Cosic A, Jukic I, Jelakovic B, Lombard JH, Phillips SA, Seric V, Mihaljevic I, Drenjancevic I. The role of cyclo-oxygenase-1 in high-salt diet-induced microvascular dysfunction in humans. J Physiol. 2015 Dec 15;593(24):5313-24. doi: 10.1113/JP271631. Epub 2015 Dec 7.
PubMed 26498129Cavka A, Cosic A, Grizelj I, Koller A, Jelakovic B, Lombard JH, Phillips SA, Drenjancevic I. Effects of AT1 receptor blockade on plasma thromboxane A2 (TXA2) level and skin microcirculation in young healthy women on low salt diet. Kidney Blood Press Res. 2013;37(4-5):432-42. doi: 10.1159/000355723. Epub 2013 Oct 13.
PubMed 24247418Cavka A, Jukic I, Ali M, Goslawski M, Bian JT, Wang E, Drenjancevic I, Phillips SA. Short-term high salt intake reduces brachial artery and microvascular function in the absence of changes in blood pressure. J Hypertens. 2016 Apr;34(4):676-84. doi: 10.1097/HJH.0000000000000852.
PubMed 26848993
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of High Salt Diet on Microvascular Reactivity in Young Healthy Subjects
- ClinicalTrials.gov ID
- NCT02727426
- Acronym / sponsor ID
- 215861071012
- Conditions
- Salt; Excess
- Keywords
- microvascular function, laser Doppler flowmetry, high salt diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is well accepted that high-salt (HS) intake is an essential risk factor in development and progression of hypertension. Results of some recent studies suggest that some of the deleterious effects of a HS diet are independent of elevated blood pressure (BP) and may occur in normotensive individuals and are associated with impaired endothelial function. However, the effects of acute salt loading on endothelial function and vascular reactivity in young healthy individuals are still scarce and inconsistent.
The purpose of present study is to determine whether one week of HS intake affects microvascular reactivity in young healthy subjects without changes in BP. In addition, the investigators sought to evaluate if potential HS diet-induced microvascular dysfunction is associated with changes in oxidative stress level and/or with modification of immunological response in young healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low salt diet | Experimental | Other: Low Salt (LS) dietAll subjects will be instructed to maintain a low-sodium (LS) diet, with an intake of less than 2.3 g of salt per day (DASH eating plan; US Department of Health and Human Services, 2006) for 7 days (washout period). |
| high salt diet | Experimental | Other: High Salt (HS) dietAfter washout period, all subjects will be instructed to maintain a high-sodium (HS) diet, with an intake of 11.2 g of salt per day for 7 days. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (8 listed)
- oral contraceptives
- drugs that could affect the endothelium
- hypertension
- coronary artery disease
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Salt (LS) dietIntake of less than 2.3 g of salt per day for 7 days. | Other | low salt diet |
| High Salt (HS) dietIntake of 11.2 g of salt per day for 7 days. | Other | high salt diet |
Primary outcome
microvascular reactivity
Time frame: two weeks after starting the protocol
Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperemia- PORH) and in response to iontophoresis of acetylcholine (ACh) (endothelium dependent vasodilation) before and after diet protocols.
3 secondary outcomes
oxidative stress
Time frame: two weeks after starting the protocol
modification of immunological response by high salt diet
Time frame: two weeks after starting the protocol
antioxidant capacity
Time frame: two weeks after starting the protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
- Background: PubMed 26498129Cavka A, Cosic A, Jukic I, Jelakovic B, Lombard JH, Phillips SA, Seric V, Mihaljevic I, Drenjancevic I. The role of cyclo-oxygenase-1 in high-salt diet-induced microvascular dysfunction in humans. J Physiol. 2015 Dec 15;593(24):5313-24. doi: 10.1113/JP271631. Epub 2015 Dec 7.
- Background: PubMed 24247418Cavka A, Cosic A, Grizelj I, Koller A, Jelakovic B, Lombard JH, Phillips SA, Drenjancevic I. Effects of AT1 receptor blockade on plasma thromboxane A2 (TXA2) level and skin microcirculation in young healthy women on low salt diet. Kidney Blood Press Res. 2013;37(4-5):432-42. doi: 10.1159/000355723. Epub 2013 Oct 13.
- Background: PubMed 26848993Cavka A, Jukic I, Ali M, Goslawski M, Bian JT, Wang E, Drenjancevic I, Phillips SA. Short-term high salt intake reduces brachial artery and microvascular function in the absence of changes in blood pressure. J Hypertens. 2016 Apr;34(4):676-84. doi: 10.1097/HJH.0000000000000852.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ines Drenjancevic, MD, PhD principal investigator
Faculty of Medicine, University of Osijek, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Salt (LS) diet and High Salt (HS) diet in people with Salt; Excess, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana - Stupin, MD, PhD (+385915134958, anacavka@mefos.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microvascular reactivity (time frame: two weeks after starting the protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02727426, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2016.