Effects on Cardiovascular Risk Factors of the Endogenous Hydroxytyrosol Generation After the Comb… (NCT02783989) | Clinical Trial Compass
CompletedNot Applicable
Effects on Cardiovascular Risk Factors of the Endogenous Hydroxytyrosol Generation After the Combined Intake of Wine and Tyrosol in Humans
Spain33 participantsStarted 2016-01-20
Plain-language 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.
Who can participate
Age range50 Years – 80 Years
SexALL
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Inclusion criteria
✓. Understanding and accepting the study procedures and signing the informed consent.
✓. Male and female volunteers aged 50 to 80 years.
✓. Participants with at least three major cardiovascular risk factors, including:
✓. Clinical diagnosis of type 2 diabetes.
✓. Clinical history and physical examination demonstrating no organic or psychiatric disorders.
✓. The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
✓. Subjects socially drinking and who had ingested wine at least once.
✓. Acceptance of following a controlled diet with a moderate content of antioxidants along the study, in which time it will be not permitted the consumption of wine/champagne (except in the framework of treatment conditions in the clinical trial) or other alcoholic drinks (beer, spirits…), but it will be allowed a maximum of: