Trials / Unknown
UnknownNCT04325191
Melatonin and Salt on Blood Vessel Function
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- University of Delaware · Academic / Other
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Melatonin | Daily consumption of a high sodium diet and melatonin for 10 days |
| OTHER | Placebo | aily consumption of a high sodium diet and placebo for 10 days |
Timeline
- Start date
- 2020-03-12
- Primary completion
- 2022-06-30
- Completion
- 2022-09-30
- First posted
- 2020-03-27
- Last updated
- 2021-04-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04325191. Inclusion in this directory is not an endorsement.