Effects on Cardiovascular Risk Factors of the Endogenous Hydroxytyrosol

Status Completed

Clinical Trial Summary

The present study will assess whether the beneficial effects of a market moderate-alcohol drinking in the form of white wine in humans could be derived from the endogenous formation of hydroxytyrosol (also known DOPET), a potent dietary anti-inflammatory and antioxidant molecule.

Clinical Trial Description

Epidemiological studies support that light to moderate alcohol drinking (10-20g per day), may reduce the risk of cardiovascular disease (CVD), stroke, dementia, depression, and all-cause mortality. In addition, moderate red wine consumption has recently shown to be inversely associated with a decline in global cognitive function and the domains of memory and flexibility. The claimed beneficial effects of the Mediterranean diet include prevention of several age-related dysfunctions including cardiovascular and neurodegenerative diseases. These effects have been related to the protection against cognitive decline associated with aging and disease by a number of polyphenols found in red wine and virgin olive oil. Neurodegenerative diseases, as all chronic degenerative diseases, are linked to inflammation and its inter-twined phenomena: the oxidation and the oxidative damage. The interrelationship among chronic degenerative diseases is also evidenced by the fact that vascular (cardiovascular) risk factors are associated to cognitive decline, and these vascular factors are currently the only known modifiable risk factors for Alzheimer disease.

There is evidence suggesting that DOPET, also known as hydroxytyrosol (HOTYR), has a role in the cardioprotective and neuroprotective properties of wine. It is a phenolic compound present in virgin olive oil and wine, and it is a potent dietary anti-inflammatory and antioxidant molecule. Biological effects of HOTYR may explain in part some of the beneficial effects for human health that have been credited to moderate ethanol intake (in form of wine).

The present project is not intended to provide support for the clinical use of moderate- dose alcohol as a treatment modality for CVD risk patients. Nevertheless, it will investigate a novel mechanism of action that may explain in part beneficial health effects associated to moderate alcohol consumption. This novel mechanism of action is mediated by compounds that at mid/long-term run are susceptible of a pharmaceutical and/or nutraceutical food development. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02783989
Study type	Interventional
Source	Parc de Salut Mar
Contact
Status	Completed
Phase	N/A
Start date	January 20, 2016
Completion date	June 25, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effects on Cardiovascular Risk Factors of the Endogenous Hydroxytyrosol Generation After the Combined Intake of Wine and Tyrosol in Humans — DOPET3

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms