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Completed

NCT Number: NCT01788670

Relevance of the Ethanol Dose in the Generation of Endogenous Hydroxytyrosol

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Parc de Salut Mar

Barcelona, 08003, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ethanol

Dietary Supplement

Water

Other

Primary outcomes

  1. Hydroxytyrosol biological fluids concentrations

    Time frame: 0-24h after administration

    Hydroxytyrosol concentrations in plasma and urine

Secondary outcomes

  1. Subjective drunkenness

    Time frame: 0-6h after administration

    Ethanol subjective effects measured using a visual analog scale

  2. Vital signs

    Time frame: 0-6h after administration

    Blood pressure, oral temperature and heart rate

  3. Ethanol concentration

    Time frame: 0-6h after administration

    Ethanol blood concentrations

  4. Ethanol metabolites concentrations

    Time frame: 0-24h after administration

    Ethanol metabolites recovery in urine

  5. Dopamine metabolites concentrations

    Time frame: 0-24h after administration

    Dopamine metabolites recovery in urine

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • Fundacion IMIM

Registry information

Official study 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).

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 11, 2013
Registry last updated
Feb 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.