Effects of high sodium on heart function and exercise protection
The Role of Oxidative Stress and Endothelial Dysfunction in High Sodium-Induced Changes in Pulsatile Hemodynamics
NA · University of Delaware · NCT04233957
This study is testing if regular exercise can help protect the heart from the harmful effects of a high sodium diet in healthy adults aged 21-45.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 45 Years |
| Sex | All |
| Sponsor | University of Delaware (other) |
| Locations | 1 site (Newark, Delaware) |
| Trial ID | NCT04233957 on ClinicalTrials.gov |
What this trial studies
This investigation explores how high sodium diets affect vascular function and the workload of the heart, particularly focusing on the relationship between sodium intake, oxidative stress, and pulsatile hemodynamics. The study aims to determine if regular aerobic exercise can mitigate the negative impacts of high sodium consumption on cardiovascular health. Participants will be healthy individuals aged 21-45, categorized as either sedentary or habitually active, and will undergo interventions involving high sodium and placebo treatments. The research seeks to uncover mechanisms linking sodium excess to cardiovascular disease risk.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 21-45 who are either sedentary or engage in regular aerobic exercise.
Not a fit: Patients with chronic diseases, a history of heart disease, or those who do not meet the specified exercise criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary recommendations and exercise regimens that protect heart health in the context of high sodium intake.
How similar studies have performed: While the specific approach of this study may be novel, previous research has indicated that dietary sodium impacts cardiovascular health, suggesting potential for meaningful findings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Newark, Delaware
- Department of Kinesiology and Applied Physiology, University of Delaware — Newark, Delaware, United States (RECRUITING)
Study contacts
- Principal investigator: David G Edwards, PhD — University of Delaware
- Study coordinator: David G Edwards, PhD
- Email: dge@udel.edu
- Phone: 302-831-3363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sodium Excess, endothelium, oxidative stress, physical activity, ventricular-vascular coupling, pulsatile load