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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a high sodium diet affects heart function and if regular exercise can protect against any negative effects. Participants will either consume an extra 3900 mg of sodium daily or join a control group receiving a placebo (dummy treatment). The trial seeks healthy adults who either exercise regularly (4+ days a week for a year) or are mostly inactive (exercise 1 or fewer days a week). This research aims to understand the impact of sodium on heart health and the potential protective role of exercise. As an unphased study, this trial offers participants the chance to contribute to important research on heart health and exercise.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy individuals without chronic diseases, it's possible that certain medications might not be allowed. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that consuming a lot of salt can harm health. Reports have found that large amounts of salt can be extremely dangerous and might even be life-threatening. Studies link high salt intake to a greater risk of strokes and heart problems.

Excessive salt consumption may also increase the risk of stomach cancer and kidney issues, which can worsen over time. Some research suggests that high-salt diets can weaken bones and lead to conditions like osteoporosis, where bones become fragile.

While the body needs a small amount of salt, too much can be harmful. Understanding these risks is important for those considering participation in a study involving a high-salt diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for hypernatremia, which typically focus on reducing sodium levels or managing hydration, the high sodium diet approach is quite unconventional. Researchers are excited about this method because it challenges the traditional understanding by exploring whether increasing sodium intake could paradoxically help regulate sodium levels in the body. This novel approach could potentially offer a new strategy for managing hypernatremia, particularly in cases where typical interventions are less effective.

What evidence suggests that this trial's treatments could be effective?

This trial will compare a high sodium diet with a placebo to study its effects on hypernatremia. Research has shown that excessive salt intake can raise blood pressure. One large study found that reducing salt for a few weeks lowered blood pressure in individuals with hypertension. High salt levels also correlate with an increased risk of heart problems, such as heart failure. Individuals who consume a lot of salt have a 20% higher risk of dying from any cause compared to those who consume less. Overall, reducing salt intake is generally considered beneficial for heart health. ^{6 7 8 9 10}

Who Is on the Research Team?

David G Edwards, PhD

Principal Investigator

University of Delaware

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6770596/

Sodium Intake and Hypertension - PMC - PubMed Central - NIH A large meta-analysis [9] showed that modest reduction in salt intake for four or more weeks causes a significant fall in BP in both hypertensive and ...

2. foodandnutritionresearch.net foodandnutritionresearch.net/index.php/fnr/article/view/10319/16824

View of Sodium – a systematic review for Nordic Nutrition ... Blood pressure (BP) rises along with increasing sodium intake from early childhood to late adulthood, and leads to hypertension among most men and women living ...

3. nutritionsource.hsph.harvard.edu nutritionsource.hsph.harvard.edu/salt-and-sodium/

Salt and Sodium - The Nutrition Source In this study, people with the highest sodium intakes had a 20% higher risk of death from any cause than people with the lowest sodium intakes.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10845896/

Sodium – a systematic review for Nordic Nutrition ... A regression analysis of these data showed that a reduction in the sodium intake of 100 mmol (2.3 g) per day would decrease SBP by 3 mmHg in the DASH diet group ...

5. mdpi.com mdpi.com/1422-0067/21/24/9474

Sodium Intake and Heart Failure High sodium or salt intake can lead to chronic comorbidities including hypertension, heart failure (HF), chronic kidney disease, stroke, ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK545426/

Sodium: Dietary Reference Intakes for Toxicity - NCBI - NIH Case reports provide evidence that acute ingestion of large doses of sodium, including rapid ingestion of salt in liquid solution, can lead to death.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2809955

Rate of Correction and All-Cause Mortality in Patients With ... Most patients were corrected according to current guidelines, with only 601 patients (14.1%) corrected by more than 8 mmol/L during the first 24 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325000456

Sodium Furthermore, a high dietary salt intake was associated with a higher risk of gastric cancer, nephrolithiasis, reduced bone mineral density, and osteoporosis [7] ...

9. foodandnutritionresearch.net foodandnutritionresearch.net/index.php/fnr/article/view/10319/16825

Sodium – a systematic review for Nordic ... Results from prospective cohort studies show that higher sodium intake is positively associated with an increased risk of stroke and cardiovascular events and ...

10. mdpi.com mdpi.com/2673-9259/5/1/1

How Dietary Habits and Nutritional Deficiencies Relate to ... Increased sodium intake elevates intra-glomerular pressure, which can contribute to or worsen chronic kidney damage, heightening the risk of progressive kidney ...