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Dietary Sodium, Oxidative Stress, and Pulsatile Hemodynamics

Primary Purpose

Sodium Excess

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Sodium
Placebo
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sodium Excess focused on measuring endothelium, oxidative stress, physical activity, ventricular-vascular coupling, pulsatile load

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Kinesiology and Applied Physiology, University of DelawareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

High Sodium

Placebo

Arm Description

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

Control Condition

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Wave reflection timing
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 wave transit time.
Forward 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 the amplitude of the forward traveling pulse wave.
24 Hour Blood Pressure
24 hour blood pressure monitoring will be performed using an ambulatory blood pressure monitor device. Average day and nighttime systolic, diastolic, and mean blood pressures will be determined.

Full Information

First Posted
December 23, 2019
Last Updated
January 16, 2020
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT04233957
Brief Title
Dietary Sodium, Oxidative Stress, and Pulsatile Hemodynamics
Official Title
The Role of Oxidative Stress and Endothelial Dysfunction in High Sodium-Induced Changes in Pulsatile Hemodynamics
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Delaware

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
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.
Detailed Description
Excess dietary sodium is associated with cardiac hypertrophy independent of changes in blood pressure. Importantly, increased arterial pulsatile load predicts left ventricular hypertrophy, and thus presents a potential mechanism through which high dietary sodium augments cardiovascular disease risk. While high sodium diets impair vascular function via an increase in oxidative stress, how high sodium influences central pulsatile hemodynamics is not known. This project aims to a) determine how impaired vascular function affects pulsatile hemodynamics and thus influences the work of the heart during periods of high sodium consumption and b) examine whether regular aerobic exercise and/or fitness protects against the deleterious effects of excess sodium.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sodium Excess
Keywords
endothelium, oxidative stress, physical activity, ventricular-vascular coupling, pulsatile load

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Sodium
Arm Type
Experimental
Arm Description
Consumption of an extra 3900 mg of dietary sodium per day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Control Condition
Intervention Type
Dietary Supplement
Intervention Name(s)
High Sodium
Intervention Description
10 days of 3900 mg of sodium/day in excess of normal dietary intake delivered via enteric capsules filled with table salt.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
10 days of enteric capsules filled with dextrose.
Primary Outcome Measure Information:
Title
Reflected Pulse Wave Amplitude
Description
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.
Time Frame
On the 10th day of each arm.
Title
Conduit artery endothelium-dependent dilation
Description
Brachial artery flow mediated dilation (FMD) will be assessed by duplex ultrasound as an index of conduit artery endothelial function.
Time Frame
On the 10th day of each arm.
Title
Arterial Stiffness
Description
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.
Time Frame
On the 10th day of each arm.
Secondary Outcome Measure Information:
Title
Wave reflection timing
Description
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 wave transit time.
Time Frame
On the 10th day of each arm.
Title
Forward Pulse Wave Amplitude
Description
Aortic pressure-flow relations will be assessed non-invasively using echocardiography and peripheral artery applanation tonometry. Wave separation analysis will be used to the amplitude of the forward traveling pulse wave.
Time Frame
On the 10th day of each arm.
Title
24 Hour Blood Pressure
Description
24 hour blood pressure monitoring will be performed using an ambulatory blood pressure monitor device. Average day and nighttime systolic, diastolic, and mean blood pressures will be determined.
Time Frame
The morning of day 9 through the morning of day 10 for each arm.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David G Edwards, PhD
Phone
302-831-3363
Email
dge@udel.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan C Patik, PhD
Phone
512-820-6387
Email
jpatik@udel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Edwards, PhD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Kinesiology and Applied Physiology, University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Edwards, PhD
Email
dge@udel.edu
First Name & Middle Initial & Last Name & Degree
Jordan Patik, PhD
Email
jpatik@udel.edu
First Name & Middle Initial & Last Name & Degree
David Edwards, PhD
First Name & Middle Initial & Last Name & Degree
Jordan Patik, PhD

12. IPD Sharing Statement

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Dietary Sodium, Oxidative Stress, and Pulsatile Hemodynamics

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