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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 days
Awards & highlights
Study 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 belowSelect...
My BMI is between 30 and 50.
Select...
I am between 25 and 45 years old.
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I am between 25 and 45 years old.
Select...
My BMI is between 30 and 50.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 days
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 moreTrial 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.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,299 Total Patients Enrolled
72 Trials studying Obesity
474,075 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I an eligible candidate for participating in this medical experiment?
"This research is seeking 55 participants with obesity (defined by a BMI between 30 and 50 kg/m2) aged 25-45."
Answered by AI
What are the primary objectives of this clinical exploration?
"As the primary objective, this clinical trial will observe how long it takes for melatonin levels to increase in dim-light conditions (dim-light melatonin onset). Secondary objectives include analyzing differences between study arms regarding cortisol concentrations, endothelin 1 concentrations found both in plasma and urine samples, as well as measuring contrasts of melatonin concentrations. All data collection is expected to take place over a time window of 7 days."
Answered by AI
How many individuals are currently engaging in the clinical trial?
"Affirmative. The details listed on clinicaltrials.gov indicate that this investigation, which was initially published on July 14th 2020, is actively recruiting patients. Approximately 55 participants must be registered from 1 medical site."
Answered by AI
Does this clinical trial accept minors as participants?
"This medical trial is enrolling participants between the ages of 25 to 45."
Answered by AI
Is there an enrollment period currently ongoing for this research?
"Affirmative. Clinicaltrials.gov hosts the latest information which states that this research trial, initiated on July 14th 2020, is still seeking participants. 55 individuals need to be brought in from a single medical site for enrollment purposes."
Answered by AI
Who else is applying?
What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
University of Alabama
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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