Oral sodium supplementation for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alabama, Birmingham, AL
Obesity+4 More
Oral sodium supplementation - Other
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether the timing of salt intake impacts blood pressure and circadian timing of factors responsible for blood pressure regulation.

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Eligible Conditions

  • Obesity
  • Salt; Excess
  • Hypertension
  • Circadian Dysregulation

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Oral sodium supplementation will improve 3 primary outcomes and 10 secondary outcomes in patients with Obesity. Measurement will happen over the course of 7 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 Estimate

1 of 3

Trial Design

2 Treatment Groups

Early Sodium
1 of 2
Late Sodium
1 of 2
Experimental Treatment

This trial requires 55 total participants across 2 different treatment groups

This trial involves 2 different treatments. Oral Sodium Supplementation is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Early Sodium
Other
Early sodium load: participants will consume a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they will continue to consume the standardized diet for 9 days and in addition will take 2 g of sodium in the form of salt tablets with breakfast each day.
Late Sodium
Other
Late sodium load: participants will consume a standardized diet providing 2.3 g of sodium per day for 7 days (run-in period), after which they will continue to consume the standardized diet for the next 9 days and in addition will take 2 g of sodium with dinner each day.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 8 days for reporting.

Who is running the study

Principal Investigator
O. M. G. M.
Orlando M. Gutierrez, MMSc, MD
University of Alabama at Birmingham

Closest Location

University of Alabama - Birmingham, AL

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
obese (BMI 30-50 kg/m2)
25-45 years of age

Patient Q&A Section

Does oral sodium supplementation improve quality of life for those with chronobiology disorders?

"Findings from a recent study showed improvements in some aspects of QoL for patients with chronobiology disorders in addition to some general improvements. More research of oral salt supplementation is indicated for patients with chronobiology disorders." - Anonymous Online Contributor

Unverified Answer

What are common treatments for chronobiology disorders?

"Patients with severe circadian rhythm disorders have a wide variety of treatment options, from medical treatments (light therapy etc.), to more invasive solutions like surgery. All of these options are often necessary for patient satisfaction depending on their condition. Chronotherapy seems to have a positive outcome, but further studies are still needed to prove this positive response." - Anonymous Online Contributor

Unverified Answer

Can chronobiology disorders be cured?

"Current medical theory states that chronic, and preferably idiopathic, disorders can be cured in an unspecified period if treatment begins as early as possible. However, this will usually have to be done by means of a medical procedure which has an unpleasant risk to a human being. Chronobiology theory states that chronic, and ideally idiopathic, disorders are always chronic. Theories and data suggest that chronic, and preferably idiopathic, disorders will have their most unpleasant symptoms at certain periods in life. Therefore, if proper treatment is provided to patients with chronobiology diseases that are considered chronic, and ideally idiopathic, it is possible that these diseases will also be cured." - Anonymous Online Contributor

Unverified Answer

What is chronobiology disorders?

"Chronobiology is a disorder that is characterized by an individual's circadian rhythm that is disrupted. Chronobiology is the study of this disturbance. Chronobiologists may investigate the effects of the circadian system on the organism's development, behavior, physiology, and pathophysiology. Chronobiologists look to find new therapies for chronobiology disorders in the hope of curing and/or improving the living standards of patients." - Anonymous Online Contributor

Unverified Answer

How many people get chronobiology disorders a year in the United States?

"Recent findings found that chronobiology disorders affect an estimated 13 million adults in the U.S. each year. Although the reasons behind development of the disorders remain unclear and their prevalence is still unknown, we believe that these data highlight the need for improved clinical awareness and better management of patients with chronobiology disorders." - Anonymous Online Contributor

Unverified Answer

What causes chronobiology disorders?

"The prevalence of chronobiology disorders is not low. However, the present-day knowledge of chronobiology is poor. In addition, there is not a standard protocol for investigating chronobiology disorders. Therefore, it is difficult to organize a study on the prevalence of chronobiology disorders. It may be necessary to establish a database of chronobiology disorders during the next few years." - Anonymous Online Contributor

Unverified Answer

What are the signs of chronobiology disorders?

"Chronobiology disorders, such as circadian rhythm sleep disorder (CRDSD), have many signs similar to other sleep disorders, such as insomnia. This review lists the main signs in CRDSD in chronological order with the age range of onset. Circadian rhythm sleep disorder symptoms can occur in people of all ages. When symptoms begin to appear, a comprehensive assessment and referral to an sleep specialist is advised. Circadian rhythm sleep disorder has many similar symptoms to other sleep disorders. These symptoms often appear during childhood to teen years. Older people may not have time for them. One is not to blame the circadian rhythm, it is how someone perceives it. Sleep disorders can disrupt the body's natural cycle. This can result in medical problems." - Anonymous Online Contributor

Unverified Answer

Has oral sodium supplementation proven to be more effective than a placebo?

"Oral NS was significantly more effective than placebo and placebo-controlled-sodium in preventing the loss of renal function (eGFR decrease and a urinary albumin increase) caused by chronic hypoalbuminemia in dialysis patients." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for chronobiology disorders?

"This report suggests that trials of treatments for chronic diseases that have not been studied for a number of years offer the greatest chances of achieving significant results. The potential value of evaluating treatments for chronic conditions that would never be accepted to current clinical practices awaits evaluation." - Anonymous Online Contributor

Unverified Answer

Is oral sodium supplementation safe for people?

"Current evidence does not support concerns that people will be adversely affected by long term or daily oral sodium supplementation. There exists a small but significant effect of salt on plasma renin activity, but the magnitude of these effects is small and may be clinically irrelevant." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating chronobiology disorders?

"These investigators have contributed little to the treatment for chronobiology disorders, and most drugs and other therapies currently available to treat these patients have no solid evidence base to support their use. Clinicians are now turning to a small, new group of drugs that have shown promise in small trials. The development of this group of treatments should continue, even though such treatment appears not to be justified from a clinical perspective." - Anonymous Online Contributor

Unverified Answer

What is oral sodium supplementation?

"Oral sodium supplementation in healthy volunteers increases resting cerebral blood flow velocity and cerebral blood flow in both young and elderly, as measured with transcranial Doppler ultrasonography. In addition, the drug improves cerebral blood flow velocity and cerebral blood flow in patients with high cerebral vascular resistance or a history of stroke; thus, oral sodium supplementation might be a beneficial tool in the management of cerebral vascular insufficiency." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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