NCT04233957

Brief Summary

High sodium diets impair vascular function, which may influence the work of the heart. This investigation is designed to determine if this change in vascular function results in a greater workload in the heart and if people who regularly exercise are protected from these effects.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 23, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

4.5 years

First QC Date

December 23, 2019

Last Update Submit

November 28, 2023

Conditions

Sodium Excess

Keywords

endotheliumoxidative stressphysical activityventricular-vascular couplingpulsatile load

Outcome Measures

Primary Outcomes (3)

  • Reflected Pulse Wave Amplitude

    Aortic pressure-flow relations will be assessed non-invasively using echocardiography and peripheral artery applanation tonometry. Wave separation analysis will be used to calculate reflected pulse wave amplitude.

    On the 10th day of each arm.

  • Conduit artery endothelium-dependent dilation

    Brachial artery flow mediated dilation (FMD) will be assessed by duplex ultrasound as an index of conduit artery endothelial function.

    On the 10th day of each arm.

  • Arterial Stiffness

    Carotid-femoral pulse wave velocity (cf-PWV) will be assessed via applanation tonometry as an index of aortic stiffness. cf-PWV will be calculated as the difference in timing of of pulse waves at the carotid and femoral arteries divided by the distance between measurements.

    On the 10th day of each arm.

Secondary Outcomes (3)

  • Wave reflection timing

    On the 10th day of each arm.

  • Forward Pulse Wave Amplitude

    On the 10th day of each arm.

  • 24 Hour Blood Pressure

    The morning of day 9 through the morning of day 10 for each arm.

Study Arms (2)

High Sodium

EXPERIMENTAL

Consumption of an extra 3900 mg of dietary sodium per day.

Dietary Supplement: High Sodium

Placebo

PLACEBO COMPARATOR

Control Condition

Other: Placebo

Interventions

High SodiumDIETARY_SUPPLEMENT

10 days of 3900 mg of sodium/day in excess of normal dietary intake delivered via enteric capsules filled with table salt.

High Sodium
PlaceboOTHER

10 days of enteric capsules filled with dextrose.

Placebo

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals (age 21-45) who are either sedentary (1 or less days of exercise per week during past year) or habitually active (4 or more days of aerobic exercise per week for a minimum of 1 year)

You may not qualify if:

  • Body mass index \<18 or \>35
  • Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90
  • Blood donation within past 8 weeks,
  • Glucose 6 phosphate dehydrogenase (G6PD) deficiency
  • A history of cancer, diabetes, or any other chronic disease
  • A history of any heart disease
  • A history of hormone therapy
  • Use of nicotine products
  • Pregnancy
  • Nursing mothers
  • Participation in regular physical activity greater than 1 day/week- but less than 4 days/week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesiology and Applied Physiology, University of Delaware

Newark, Delaware, 19713, United States

RECRUITING

MeSH Terms

Conditions

HypernatremiaMotor Activity

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Officials

  • David G Edwards, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David G Edwards, PhD

CONTACT

302-831-3363dge@udel.edu

Jordan C Patik, PhD

CONTACT

512-820-6387jpatik@udel.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2019

First Posted

January 18, 2020

Study Start

January 1, 2020

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

US(1)