Clinical trial NCT04325191: Melatonin and Salt on Blood Vessel Function
Official title: Melatonin and Salt on Blood Vessel Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: Vascular Health
Melatonin
Dietary Sodium
Blood Pressure
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized crossover design trial.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Conduit artery endothelial-dependent function
timeFrame: Day 10
measure: Microvascular function
timeFrame: Day 10
Secondary outcomes:
measure: Blood pressure reactivity
timeFrame: Day 10
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Shannon L Lennon, PhD
role: PRINCIPAL_INVESTIGATOR
References: