Clinical trial NCT01788670: Relevance of the Ethanol Dose in the Generation of Endogenous Hydroxytyrosol
Official title: Hydroxytyrosol as an Endogenous and Natural Antioxidant: Modulation by Alcohol Intake. Substudy 1. Evaluating the Relevance of the Ethanol Dose in the Generation of Endogenous Hydroxytyrosol (DOPET).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Contribution of Ethanol on Hydroxytyrosol Formation
Keywords: Antioxidants, Central Nervous System Agents
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Fundacion IMIM
First posted: 2013-02-11
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Health benefits for humans derived from low dose intake of ethanol could partially be explained by its interaction with dopamine (DA) oxidative metabolism. Ethanol is expected to induce an increase in the formation of a DA minor metabolite: DOPET (hydroxytyrosol). Hydroxytyrosol is one of the most potent antioxidants present in Mediterranean Diet. The study is aimed at establishing the contribution of ethanol on hydroxytyrosol formation.


Eligibility criteria: Inclusion Criteria:

* 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.
* The body mass index (BMI=weigh/height2) will range from 19 to 27 kg/m2, and the weight from 50 to 110 kg.
* Understanding and accepting the study procedures and signing the informed consent.

Exclusion Criteria:

* Not meeting the inclusion criteria.
* History or clinical evidence of alcoholism, drug abuse, or regular use of psychoactive drugs.
* Having suffered any organic disease or major surgery in the three months prior to the study start.
* History of psychiatric disorders.
* Smokers of more than 20 cigarettes per day.
* Taking more than 30 g of alcohol a day
* Regular use of any drug in the month prior to the study sessions.The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
* Blood donation 8 weeks before or participation in other clinical trials with drugs in the previous 12 weeks.
* Subjects with intolerance or adverse reactions to ethanol
* History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
* Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
* Subjects with positive serology to Hepatitis B, C or HIV.

To be eligible, the subjects must agree to follow a diet free from ethanol and olive oil in the 72 hours prior to the start of each session and until the end of the study.

Primary outcomes:
measure: Hydroxytyrosol biological fluids concentrations
timeFrame: 0-24h after administration
Secondary outcomes:
measure: Subjective drunkenness
timeFrame: 0-6h after administration
measure: Vital signs
timeFrame: 0-6h after administration
measure: Ethanol concentration
timeFrame: 0-6h after administration
measure: Ethanol metabolites concentrations
timeFrame: 0-24h after administration
measure: Dopamine metabolites concentrations
timeFrame: 0-24h after administration
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Parc de Salut Mar
Study officials:
affiliation: Parc de Salut Mar
name: Magí Farré, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perez-Mana C, Farre M, Pujadas M, Mustata C, Menoyo E, Pastor A, Langohr K, de la Torre R. Ethanol induces hydroxytyrosol formation in humans. Pharmacol Res. 2015 May-Jun;95-96:27-33. doi: 10.1016/j.phrs.2015.02.008. Epub 2015 Mar 20.