Melatonin and Salt on Blood Vessel Function

Cardiovascular Risk Factor Clinical Trial

Official title:

Melatonin and Salt on Blood Vessel Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04325191
• Other study ID #: 1534734
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: April 2021
• Source: University of Delaware
• Contact: Macarena Ramos Gonzalez, MS
• Phone: (302)831-3954
• Email: macramos[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Increased dietary sodium causes increases in oxidative stress and damages blood vessels. Americans eat more than the recommended amount of sodium. Melatonin is a powerful endogenous antioxidant that has reduced oxidative stress levels in clinical and healthy populations. This study will investigate whether melatonin can attenuate the negative effects of sodium on blood vessels.

Description:

Americans consume on average double the recommended amount of sodium established by organizations such as the American Heart Association and the Dietary Guidelines for Americans. Excess dietary sodium damages the inside of our blood vessels in a process known as endothelial dysfunction. This reduces the ability of blood vessels to dilate as much. This type of dysfunction can lead to the development of cardiovascular disease. Animal and human studies have identified one potential mechanism linking high sodium consumption and endothelial dysfunction; that is oxidative stress. Furthermore, high dietary sodium consumption has been shown to increase blood pressure reactivity in animal studies. Melatonin is a powerful endogenous antioxidant that has reduced oxidative stress levels in clinical and healthy populations. Melatonin has been shown to attenuate sympathetic responses, but research is limited. Whether supplementation of melatonin can offset the deleterious effects of a high sodium diet is unknown. Thus, the purpose of this study is to investigate the effect of melatonin supplementation compared to a placebo on markers of oxidative stress and blood vessel function in healthy young adults that consume a 10-day high sodium diet. Our hypotheses are that: 1) melatonin will reduce oxidative stress levels and restore blood vessel function and 2) melatonin will reduce the sympathetic nerve response to high sodium consumption.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• healthy

• normal blood pressure

Exclusion Criteria:

• hypertension

• heart disease

• diabetes

• kidney disease

• renal impairment

• cancer

• obese (BMI =30)

• sleep disorder

• use of tobacco products

• pregnant or breastfeeding

• take any medications for the above conditions

• endurance trained athletes

• night shift worker

• melatonin or antioxidant consumption for the previous 3 months

• use of selective serotonin reuptake inhibitors

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Dietary Supplement:
• Melatonin
Daily consumption of a high sodium diet and melatonin for 10 days

Other:
• Placebo
aily consumption of a high sodium diet and placebo for 10 days

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conduit artery endothelial-dependent function	Assessed by brachial artery flow mediated dilation (FMD)	Day 10
Primary	Microvascular function	Assessed by Near Infrared Spectroscopy (NIRS)	Day 10
Secondary	Blood pressure reactivity	Assessed by the change in blood pressure during Handgrip Exercise and Cold Pressor test from baseline	Day 10