Melatonin and Salt on Blood Vessel Function

University of Delaware

Status: Unknown

Conditions: Cardiovascular Risk Factor

Treatments: Other: Placebo; Dietary Supplement: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT04325191

1534734

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 2 patient groups, including a placebo group

High Salt and Melatonin

Experimental group

Description:

Subjects will consume sodium pills throughout the day achieving a total of 6900 mg sodium/day (4600 mg of sodium from pills and 2300 mg from diet) and will supplement with 10 mg (single dose) of melatonin at night.

Treatment:

Dietary Supplement: Melatonin

High Salt and Placebo

Placebo Comparator group

Description:

Subjects will consume sodium pills throughout the day achieving a total of 6900 mg sodium/day (4600 mg of sodium from pills and 2300 mg from diet) and will supplement with a lactose placebo (single dose) at night.

Treatment:

Other: Placebo