Recruiting

Melatonin & Salt

Sponsor:

University of Delaware

Code:

NCT04325191

Conditions

Cardiovascular Risk Factor

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Melatonin

Placebo

Study Details

Brief 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.

Conditions

Cardiovascular Risk Factor

Study ID

NCT04325191

Start date

Mar 12, 2020

Status verified date

Apr, 2021

Completion date

Sep 30, 2022

Anticipated

Primary completion date

Jun 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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 Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Melatonin

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

Placebo

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

Primary outcome measure

  • Conduit artery endothelial-dependent function [ Time Frame: Day 10 ]
  • Microvascular function [ Time Frame: Day 10 ]

Central Contacts and Locations

Central contacts

Macarena Ramos Gonzalez, MS

(302)831-3954macramos@udel.edu

Shannon L Lennon, PhD

3028312798slennon@udel.edu

Locations

University of Delaware

Recruiting

Newark, Delaware, United States, 19711

Contacts

Liza J Walker, BS

302-831-3181lizaj@udel.edu

Shannon L Lennon, PhD

(302)831-2798slennon@udel.edu

More Information

Sponsor

University of Delaware

Last update posted

Apr 28, 2021

Last verified

Apr, 2021

Keywords

  • Vascular Health
  • Melatonin
  • Dietary Sodium
  • Blood Pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Delaware on 2021-04-28.