Relevance of the Ethanol Dose in the Generation of Endogenous Hydroxytyrosol

NCT01788670 | Completed Phase 1

• 1 other identifier: Hidroxitirosol/FIS/1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Contribution of Ethanol on Hydroxytyrosol Formation

Keywords

Antioxidants, Central Nervous System Agents

Outcome Measures

Primary Outcomes (1)

• Hydroxytyrosol biological fluids concentrations

  Hydroxytyrosol concentrations in plasma and urine

  0-24h after administration

Secondary Outcomes (5)

• Subjective drunkenness

  0-6h after administration

• Vital signs

  0-6h after administration

• Ethanol concentration

  0-6h after administration

• Ethanol metabolites concentrations

  0-24h after administration

• Dopamine metabolites concentrations

  0-24h after administration

Study Arms (3)

Water

PLACEBO COMPARATOR

Lemon-flavoured water (150 ml)

Other: Water

Ethanol high dose

ACTIVE COMPARATOR

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).

Dietary Supplement: Ethanol

Ethanol low dose

ACTIVE COMPARATOR

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).

Dietary Supplement: Ethanol

Interventions

Ethanol DIETARY_SUPPLEMENT

Ethanol high dose; Ethanol low dose

Water OTHER

Water

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Fundacion IMIM: collaborator

Study Sites (1)

Parc de Salut Mar

Barcelona, Barcelona, 08003, Spain

Location

Related Publications (1)

• 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.

  PMID: 25801942 DERIVED

MeSH Terms

Interventions

Ethanol; Water

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Magí Farré, MD, PhD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 11, 2013
• Study Start: May 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 11, 2013

Record last verified: 2013-02

Locations

ES (1)