Recruiting

Observational Study

Sponsor:

University of Delaware

Code:

NCT04233957

Conditions

Sodium Excess

Eligibility Criteria

Sex: All

Age: 21 - 45

Healthy Volunteers: Accepted

Interventions

High Sodium

Placebo

Study Details

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.

Conditions

Sodium Excess

Study ID

NCT04233957

Start date

Jan 1, 2020

Status verified date

Nov, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: High Sodium

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

placebo comparator: Placebo

Control Condition

Interventions

High Sodium

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

Placebo

10 days of enteric capsules filled with dextrose.

Primary outcome measure

  • Reflected Pulse Wave Amplitude [ Time Frame: On the 10th day of each arm. ]
  • Conduit artery endothelium-dependent dilation [ Time Frame: On the 10th day of each arm. ]
  • Arterial Stiffness [ Time Frame: On the 10th day of each arm. ]

Central Contacts and Locations

Central contacts

David G Edwards, PhD

302-831-3363dge@udel.edu

Jordan C Patik, PhD

512-820-6387jpatik@udel.edu

Locations

Department of Kinesiology and Applied Physiology, University of Delaware

Recruiting

Newark, Delaware, United States, 19713

Contacts

David Edwards, PhD

dge@udel.edu

Jordan Patik, PhD

jpatik@udel.edu

Principal Investigator:

David Edwards, PhD

More Information

Sponsor

University of Delaware

Last update posted

Nov 29, 2023

Last verified

Nov, 2023

Keywords

  • endothelium
  • oxidative stress
  • physical activity
  • ventricular-vascular coupling
  • pulsatile load

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Delaware on 2023-11-29.