Oral sodium supplementation for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obesity+4 More
Oral sodium supplementation - Other
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

1 of 3

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

1 of 3

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: Other
Late Sodium
Other
Experimental Group · 1 Intervention: Oral sodium supplementation · Intervention Types: Other

Trial 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 preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: October 27th, 2022

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?
Alabama100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Alabama100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%