Melatonin and Salt on Blood Vessel Function

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 31, 2021

Detailed 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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: 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.
  • Placebo Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Conduit artery endothelial-dependent function
    • Time Frame: Day 10
    • Assessed by brachial artery flow mediated dilation (FMD)
  • Microvascular function
    • Time Frame: Day 10
    • Assessed by Near Infrared Spectroscopy (NIRS)

Secondary Measures

  • Blood pressure reactivity
    • Time Frame: Day 10
    • Assessed by the change in blood pressure during Handgrip Exercise and Cold Pressor test from baseline

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Delaware
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shannon L Lennon, PhD, Principal Investigator, University of Delaware
  • Overall Contact(s)
    • Macarena Ramos Gonzalez, MS, (302)831-3954, macramos@udel.edu

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