Timing of Sodium Intake and Nocturnal Sodium Excretion and Blood Pressure in Obese African Americans (NCT04021355) | Clinical Trial Compass
CompletedNot Applicable
Timing of Sodium Intake and Nocturnal Sodium Excretion and Blood Pressure in Obese African Americans
United States53 participantsStarted 2020-07-14
Plain-language summary
Experimental data have shown that timing of sodium intake impacts diurnal patterns of sodium excretion. The purpose of this study is to test the hypothesis that the time of day for salt intake impacts (1) blood pressure rhythms and urinary sodium excretion and (2) circadian timing of factors responsible for blood pressure regulation and cardiometabolic health in obese individuals. These studies will address two aims. The first aim will test the hypothesis that limiting high salt intake prior to sleep increases day-night differences in blood pressure, improves timing of urinary sodium excretion, and improves metabolic risk factors. The second aim will test the hypothesis that limiting high salt intake prior to sleep preferentially improves rhythmicity in peripheral vs. central circadian clock factors linked to renal sodium handling. The proposed hypothesis-driven studies will determine how timing of sodium intake affects diurnal blood pressure and circadian timing of factors responsible for blood pressure control and metabolic health, with the ultimate goal of identifying novel strategies to treat nocturnal hypertension and metabolic disease in obesity.
Who can participate
Age range
25 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* obese (BMI 30-50 kg/m2)
* 25-45 years of age
Exclusion Criteria:
* evidence of kidney disease (eGFR \< 60 ml/min/1.73m2 or abnormal urinalysis)
* elevated BP (\>150/90 mmHg \[measured at screening in duplicate after 10min lying recumbent\])
* elevated fasting glucose (\>126 g/dL on screening labs)
* severe anemia (hemoglobin \< 8 g/dL for women or \< 9 g/dL for men)
* significant psychiatric illness (as assessed by a validated screening form)
* past or present drug or alcohol abuse (drug screen)
* taking 2 or more BP medications or supplements on a regular basis
* alcohol intake more than 2 drinks/day
* pregnancy
* women taking hormone replacement therapy, or post-menopausal women;
* shift worker
* sleep disorders (such as sleep apnea assessed by Apnea Link)
* major chronic disease (e.g., diabetes, lymphocyte disorders)
* history of smoking or use of tobacco products within the past year
* use of sleep medications, hypnotics, stimulants, or anti-depressants
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study focused on obese African Americans with high blood pressure and looked at how the timing of salt intake during the day might affect overnight blood pressure — given my own background and health profile, is this kind of research relevant to how my doctor might think about managing my blood pressure?
2The trial measured something called 'dim-light melatonin onset' alongside blood pressure and body temperature, which suggests it was exploring how the body's internal clock might connect to blood pressure control — is there anything about my sleep patterns or circadian rhythms that my doctor thinks could be affecting my blood pressure?
3Since this trial is now completed, has my doctor seen any published findings from it, and could those results influence recommendations about what time of day I eat salty foods?
4This study specifically enrolled obese African Americans, a group known to have higher rates of salt-sensitive hypertension — does my doctor think salt sensitivity is a factor in my case, and should that change how I think about sodium in my diet?
5Are there any ongoing studies or current treatment approaches based on the idea of timing when you eat salt across the day that my doctor thinks would be worth exploring as part of managing my blood pressure?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
24-hour blood pressure
Timeframe: 7 days
2
Core Body Temperature
Timeframe: 7 days
3
Timing of plasma melatonin increase under dim-light conditions (dim-light melatonin onset)