Oral sodium supplementation for Obesity
Phase-Based Progress Estimates
Effectiveness
Safety
Obesity+4 More
Oral sodium supplementation - OtherEligibility
18 - 65
All Sexes
What conditions do you have?
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Eligibility
18 - 65
All Sexes
What conditions do you have?
Select
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.
Eligible Conditions
- Obesity
- Salt; Excess
- Hypertension
- Circadian Dysregulation
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 10 Secondary · Reporting Duration: 8 days
7 days
24-hour blood pressure
Core Body Temperature
8 days
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
Concentrations of plasma and urine endothelin 1
Concentrations of plasma cortisol
Concentrations of plasma cytokine (TNA-alpha, IL-1, IL-6, IL-12, IL-17, IL-18, IL-23, IL-10, TGB-beta)
Concentrations of plasma melatonin
Concentrations of plasma vasopressin
Flow cytometric analysis of circulating immune cells (CD3+, CD4+, CD8+, CD14+, CD45+)
Peripheral blood monocyte clock gene (CLOCK, Bmal1, per1, per2, Rev-erb-alpha, cry1, cry2) expression
Timing of plasma melatonin increase under dim-light conditions (dim-light melatonin onset)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Early Sodium
1 of 2
Late Sodium
1 of 2
Experimental Treatment
55 Total Participants · 2 Treatment Groups
Primary Treatment: Oral sodium supplementation · No Placebo Group · N/A
Early Sodium
Other
Experimental Group · 1 Intervention: Oral sodium supplementation · Intervention Types: OtherLate Sodium
Other
Experimental Group · 1 Intervention: Oral sodium supplementation · Intervention Types: OtherTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 days
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,420 Previous Clinical Trials
2,217,874 Total Patients Enrolled
65 Trials studying Obesity
458,759 Patients Enrolled for Obesity
Eligibility Criteria
Age 18 - 65 · All Participants · 2 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are 25 to 45 years of age.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| Alabama | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of Alabama | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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