Melatonin and Salt on Blood Vessel Function
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2020
CompletedFirst Submitted
Initial submission to the registry
March 19, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedApril 28, 2021
April 1, 2021
2.3 years
March 19, 2020
April 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 (1)
Blood pressure reactivity
Day 10
Study Arms (2)
High Salt and Melatonin
EXPERIMENTALSubjects 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.
High Salt and Placebo
PLACEBO COMPARATORSubjects 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
Eligibility Criteria
You may qualify if:
- healthy
- normal blood pressure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Delaware
Newark, Delaware, 19711, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon L Lennon, PhD
University of Delaware
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participant will not know if they are receiving the melatonin or placebo pills.
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2020
First Posted
March 27, 2020
Study Start
March 12, 2020
Primary Completion
June 30, 2022
Study Completion
September 30, 2022
Last Updated
April 28, 2021
Record last verified: 2021-04