Impact of Sodium Timing on Blood Pressure in Obese African Americans
Timing of Sodium Intake and Nocturnal Sodium Excretion and Blood Pressure in Obese
This study is testing if changing when obese African American adults eat salty foods can help lower their blood pressure and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 25 Years to 45 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT04021355 on ClinicalTrials.gov |
What this trial studies
This study investigates how the timing of sodium intake affects blood pressure rhythms and urinary sodium excretion in obese African American adults. It aims to determine whether limiting high salt intake before sleep can enhance day-night differences in blood pressure and improve metabolic risk factors. The study will involve a cross-over feeding design with 55 participants, monitoring their blood pressure and sodium excretion patterns over a 24-hour period. The research focuses on understanding the circadian timing of factors that regulate blood pressure and cardiometabolic health.
Who should consider this trial
Good fit: Ideal candidates are obese African American adults aged 25-45 with a BMI between 30-50 kg/m2.
Not a fit: Patients with significant kidney disease, severe hypertension, or other major chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved blood pressure management and metabolic health in obese individuals through dietary modifications.
How similar studies have performed: While the specific approach of timing sodium intake is novel, related studies have shown that dietary timing can influence metabolic and cardiovascular health.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama
- University of Alabama — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Orlando Gutierrez, MD
- Email: ogutierrez@uabmc.edu
- Phone: 205-996-2736
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.