Status:
COMPLETED
Timing of Sodium Intake and Nocturnal Sodium Excretion and Blood Pressure in Obese African Americans
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Obesity
Hypertension
Eligibility:
All Genders
25-45 years
Phase:
NA
Brief 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...
Detailed Description
Timing of food intake affects a variety of pathophysiological systems. The Western diet, which is high in salt, also contributes to excess morbidity and mortality related to obesity and hypertension. ...
Eligibility Criteria
Inclusion
- obese (BMI 30-50 kg/m2)
- 25-45 years of age
Exclusion
- 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
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04021355
Start Date
July 14 2020
End Date
July 31 2025
Last Update
December 17 2025
Active Locations (1)
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1
University of Alabama
Birmingham, Alabama, United States, 35294