Relevance of the Ethanol Dose in the Generation of Endogenous Hydroxytyrosol

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 2010

Interventions

  • Dietary Supplement: Ethanol
  • Other: Water

Arms, Groups and Cohorts

  • Placebo Comparator: Water
    • Lemon-flavoured water (150 ml)
  • Active Comparator: Ethanol high dose
    • 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).
  • Active Comparator: Ethanol low dose
    • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Hydroxytyrosol biological fluids concentrations
    • Time Frame: 0-24h after administration
    • Hydroxytyrosol concentrations in plasma and urine

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Parc de Salut Mar
  • Collaborator
    • Fundacion IMIM
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Magí Farré, MD, PhD, Principal Investigator, Parc de Salut Mar

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