NCT04021355Completed
Timing of Sodium Intake and Nocturnal Sodium Excretion and Blood Pressure in Obese African Americans
Timing of Sodium Intake and Nocturnal Sodium Excretion and Blood Pressure in Obese
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 61 (actual)
- First submitted
- 11 Jul 2019
- Start date
- 14 Nov 2020
- Primary completion date
- 14 Jun 2025
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT04021355
What you commit to
- Study type: Interventional
- Participants enrolled: 61
- From 14 Nov 2020 to the primary completion date, 14 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- past or present drug or alcohol abuse (drug screen)
- taking 2 or more BP medications or supplements on a regular basis
- women taking hormone replacement therapy, or post-menopausal women;
- use of sleep medications, hypnotics, stimulants, or anti-depressants
Other illness
- significant psychiatric illness (as assessed by a validated screening form)
- sleep disorders (such as sleep apnea assessed by Apnea Link)
- history of smoking or use of tobacco products within the past year
Lab values
- evidence of kidney disease (eGFR \< 60 ml/min/1.73m2 or abnormal urinalysis)
- elevated fasting glucose (\>126 g/dL on screening labs)
- severe anemia (hemoglobin \< 8 g/dL for women or \< 9 g/dL for men)
- major chronic disease (e.g., diabetes, lymphocyte disorders)
Other
- elevated BP (\>150/90 mmHg \[measured at screening in duplicate after 10min lying recumbent\])
- alcohol intake more than 2 drinks/day
- pregnancy
- shift worker
Who the study is looking for
- obese (BMI 30-50 kg/m2)
- 25-45 years of age
Age in the registry: 25 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.