Melatonin and Salt on Blood Vessel Function

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 Overview

• Status: Recruiting
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Dietary supplement: Melatonin; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Macarena Ramos Gonzalez, MS; Phone Number: (302)831-3954; Email: macramos@udel.edu

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19711
      • Recruiting
      • University of Delaware
      • Contact: Liza J Walker, BS; Phone Number: 302-831-3181; Email: lizaj@udel.edu
      • Contact: Shannon L Lennon, PhD; Phone Number: (302)831-2798; Email: slennon@udel.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Dietary supplement: Melatonin; Daily consumption of a high sodium diet and melatonin for 10 days
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.	Other: Placebo; aily consumption of a high sodium diet and placebo for 10 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Delaware

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Melatonin; Blood Pressure; Dietary Sodium; Vascular Health
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: 1534734

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No