Dietary Salt and Microvascular Function

NCT ID: NCT02727426

Last Updated: 2016-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Salt; Excess

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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low salt diet

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).

Group Type EXPERIMENTAL

Low Salt (LS) diet

Intervention Type OTHER

Intake of less than 2.3 g of salt per day for 7 days.

high salt diet

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.

Group Type EXPERIMENTAL

High Salt (HS) diet

Intervention Type OTHER

Intake of 11.2 g of salt per day for 7 days.

Interventions

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Low Salt (LS) diet

Intake of less than 2.3 g of salt per day for 7 days.

Intervention Type OTHER

High Salt (HS) diet

Intake of 11.2 g of salt per day for 7 days.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- healthy volunteers

Exclusion Criteria

* oral contraceptives
* drugs that could affect the endothelium
* hypertension
* coronary artery disease
* diabetes
* hyperlipidaemia
* renal impairment
* cerebrovascular and peripheral artery disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Josip Juraj Strossmayer University of Osijek

OTHER

Sponsor Role lead

Responsible Party

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Ines Drenjancevic

Vice Dean for Science, Faculty of Medicine Josip Juraj Strossmayer University of Osijek

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ines Drenjancevic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, University of Osijek, Croatia

Locations

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Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology

Osijek, , Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Ana - Stupin, MD, PhD

Role: CONTACT

+385915134958

Ines - Drenjancevic, MD, PhD

Role: CONTACT

+385912241406

Facility Contacts

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Ana Stupin, MD, PhD

Role: primary

'385915134598

Ines Drenjancevic, MD, PhD

Role: backup

'385912241406

References

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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.

Reference Type BACKGROUND
PMID: 26498129 (View on PubMed)

Cavka 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.

Reference Type BACKGROUND
PMID: 24247418 (View on PubMed)

Cavka 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.

Reference Type BACKGROUND
PMID: 26848993 (View on PubMed)

Other Identifiers

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215861071012

Identifier Type: -

Identifier Source: org_study_id

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