Relevance of the Ethanol Dose in the Generation of Endogenous Hydroxytyrosol

Phase 1

Completed

• Conditions: Contribution of Ethanol on Hydroxytyrosol Formation
• Interventions: Other: Water; Dietary Supplement: Ethanol

• Registration Number: NCT01788670
• Lead Sponsor: Parc de Salut Mar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2013-02
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-07
• Last Update Submitted: 2013-02-07
• Study First Posted: 2013-02-11
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Water	Water	Lemon-flavoured water (150 ml)
Ethanol high dose	Ethanol	The high dose corresponds to 30 g of ethanol in pilot cohort 1, to 12 g of ethanol in pilot cohort 2 and to 42 g of ethanol in pilot cohort 3. For the definitive study the high dose corresponds to 30 g of ethanol. Ethanol was administered as a single dose of pure ethanol diluted in lemon-flavoured water (150 ml each beverage).
Ethanol low dose	Ethanol	The low dose corresponds to 18 g of ethanol in pilot cohort 1, to 6 g of ethanol in pilot cohort 2 and to 24 g of ethanol in pilot cohort 3. For the definitive study the low dose corresponds to 18 g of ethanol. Ethanol was administered as a single dose of pure ethanol diluted in lemon-flavoured water (150 ml each beverage).

Primary Outcome Measures

Name	Time	Method
Hydroxytyrosol biological fluids concentrations	0-24h after administration	Hydroxytyrosol concentrations in plasma and urine

Secondary Outcome Measures

Name	Time	Method
Subjective drunkenness	0-6h after administration	Ethanol subjective effects measured using a visual analog scale
Vital signs	0-6h after administration	Blood pressure, oral temperature and heart rate
Ethanol concentration	0-6h after administration	Ethanol blood concentrations
Ethanol metabolites concentrations	0-24h after administration	Ethanol metabolites recovery in urine
Dopamine metabolites concentrations	0-24h after administration	Dopamine metabolites recovery in urine

Trial Locations

Locations (1)

Parc de Salut Mar; 🇪🇸 Barcelona, Spain