Melatonin and Salt on Blood Vessel Function | NCT04325191

Studies
Melatonin and Salt on Blood Vessel Function

NCT04325191

Sponsor

University of Delaware

Status

Unknown status

Last Update Posted

Apr 28, 2021Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Cardiovascular Risk Factor

Interventions

Melatonin
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 12, 2020Actual

Primary Completion Date

Jun 30, 2022Estimated

Completion Date

Sep 30, 2022Estimated

First Submitted Date

Mar 19, 2020

First Submission Date that Met QC Criteria

Mar 25, 2020

First Posted Date

Mar 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2021

Last Update Posted Date

Apr 28, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High Salt and Melatonin	Experimental	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
High Salt and Placebo	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Melatonin	Dietary Supplement	Daily consumption of a high sodium diet and melatonin for 10 days	High Salt and Melatonin

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Macarena Ramos Gonzalez, MS	Contact	(302)831-3954		macramos@udel.edu
Shannon L Lennon, PhD	Contact	3028312798		slennon@udel.edu

Overall Officials

Name	Affiliation	Role
Shannon L Lennon, PhD	University of Delaware	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Delaware	Recruiting	Newark	Delaware	19711	United States

Type	Date	Date Unknown
Release	Mar 8, 2024
Reset	Aug 9, 2024

Submission Tracking

Estimated Results First Submitted Date

Mar 8, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 8, 2024			Aug 9, 2024

Intervention Browse Module

MeSH Terms

ID	Term
D008550	Melatonin

Ancestor Terms

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

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Browse Branches

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