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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

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
24-hour blood pressure
Core Body Temperature
Timing of plasma melatonin increase under dim-light conditions (dim-light melatonin onset)
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,599 Previous Clinical Trials
2,287,865 Total Patients Enrolled
72 Trials studying Obesity
474,223 Patients Enrolled for Obesity

Media Library

Oral sodium supplementation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04021355 — N/A
Obesity Research Study Groups: Late Sodium, Early Sodium
Obesity Clinical Trial 2023: Oral sodium supplementation Highlights & Side Effects. Trial Name: NCT04021355 — N/A
Oral sodium supplementation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04021355 — N/A
~11 spots leftby Jul 2025