Melatonin and Salt on Blood Vessel Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-12

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a randomized crossover design trial.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Participant will not know if they are receiving the melatonin or placebo pills.

Study Groups

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High Salt and Melatonin

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.

Group Type EXPERIMENTAL

Melatonin

Intervention Type DIETARY_SUPPLEMENT

Daily consumption of a high sodium diet and melatonin for 10 days

High Salt and Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

aily consumption of a high sodium diet and placebo for 10 days

Interventions

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Melatonin

Daily consumption of a high sodium diet and melatonin for 10 days

Intervention Type DIETARY_SUPPLEMENT

Placebo

aily consumption of a high sodium diet and placebo for 10 days

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes