High Sodium Diet for Hypernatremia

Overseen By David Edwards, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Disqualifiers: Cancer, Diabetes, Heart disease, others

Compensation: Varies

Number of Visits: 1

Duration: 10 days

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

David G Edwards, PhD

Principal Investigator

University of Delaware

Eligibility Criteria

This trial is for healthy adults aged 21-45 who are either not very active (exercising at most once a week) or very active (exercising four or more days a week). People with certain health conditions, pregnant women, nursing mothers, smokers, and those outside the specified body mass index range cannot participate.

Inclusion Criteria

I am between 21-45 years old and either mostly inactive or very active.

Exclusion Criteria

Your blood pressure is too high, with the top number (systolic) above 140 and/or the bottom number (diastolic) above 90.

You exercise between 1 to 3 days a week on a regular basis.

I have undergone hormone therapy in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume an extra 3900 mg of dietary sodium per day or a placebo for 10 days

10 days

1 visit (in-person) on the 10th day of each arm

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• High Sodium
• Placebo

Trial Overview The study is testing how high sodium diets affect heart workload and blood vessel function. It will also explore if regular exercise offers protection against these effects. Participants will be given either a high sodium diet or a placebo to compare outcomes.

Participant Groups

Group I: High Sodium Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Control Condition

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+