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Sodium Intake Timing for High Blood Pressure

N/A

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Obese individuals with BMI 30-50 kg/m2

Aged between 25-45 years

Must not have

Evidence of kidney disease (eGFR < 60 ml/min/1.73m2 or abnormal urinalysis)

Women taking hormone replacement therapy, or post-menopausal women

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the hypothesis that the time of day for salt intake impacts blood pressure rhythms and urinary sodium excretion in obese individuals.

Who is the study for?

This trial is for obese African Americans aged 25-45 with a BMI of 30-50. It's not suitable for those with drug/alcohol abuse history, high alcohol consumption, pregnancy, hormone therapy use, sleep medication or antidepressant users, kidney disease sufferers, very high blood pressure individuals (>150/90 mmHg), shift workers, sleep disorder patients (like apnea), major chronic diseases like diabetes or severe anemia.

What is being tested?

The study tests if the timing of salt intake affects blood pressure rhythms and urinary sodium excretion in obese people. Participants will limit salt before bedtime to see if it improves day-night blood pressure differences and metabolic risk factors by influencing circadian clock factors linked to renal sodium handling.

What are the potential side effects?

While specific side effects are not listed for oral sodium supplementation in this context, potential risks may include increased blood pressure and related complications due to changes in sodium intake patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is between 30 and 50.

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I am between 25 and 45 years old.

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I am between 25 and 45 years old.

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My BMI is between 30 and 50.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced or I have abnormal urine test results.

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I am a woman on hormone replacement therapy or I am post-menopausal.

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I regularly take 2 or more blood pressure medications or supplements.

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I have a major chronic condition like diabetes or a lymphocyte disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

24-hour blood pressure

Core Body Temperature

Timing of plasma melatonin increase under dim-light conditions (dim-light melatonin onset)

Secondary study objectives

24-hour urinary sodium excretion

Buccal cell clock gene expression (CLOCK, Bmal1, per1, per2, Rev-erb-alpha, cry1, cry2)

Concentrations of plasma and urine aldosterone

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Late SodiumExperimental Treatment1 Intervention

Late sodium load: participants will consume a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they will continue to consume the standardized diet for the next 9 days and in addition will take 2 g of sodium with dinner each day.

Group II: Early SodiumExperimental Treatment1 Intervention

Early sodium load: participants will consume a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they will continue to consume the standardized diet for 9 days and in addition will take 2 g of sodium in the form of salt tablets with breakfast each day.

0 / 8Eligibility criteria met