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Sodium Intake Timing for High Blood Pressure
Birmingham, AL
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.
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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 belowSelect...
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.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 days
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 moreAwards & 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.
Find a Location
Closest Location:University of Alabama· Birmingham, AL
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,672 Previous Clinical Trials
2,457,160 Total Patients Enrolled
74 Trials studying Obesity
469,234 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious mental illness, as determined by a specific evaluation form.My kidney function is reduced or I have abnormal urine test results.You have smoked or used tobacco products in the last year.I am a woman on hormone replacement therapy or I am post-menopausal.I have been diagnosed with a sleep disorder like sleep apnea.Your blood sugar levels are too high when you haven't eaten for a while.Your blood doesn't have enough hemoglobin.Your blood pressure is higher than 150/90 mmHg when measured twice while lying down.I regularly take 2 or more blood pressure medications or supplements.You drink more than 2 alcoholic drinks every day.I use sleep aids, stimulants, or antidepressants.You have a history of using drugs or drinking too much alcohol.My BMI is between 30 and 50.I am between 25 and 45 years old.I have a major chronic condition like diabetes or a lymphocyte disorder.You work in shifts, like at night or early in the morning.I am between 25 and 45 years old.My BMI is between 30 and 50.
Research Study Groups:
This trial has the following groups:- Group 1: Late Sodium
- Group 2: Early Sodium
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.