Relevance of the Ethanol Dose in the Generation of Endogenous Hydroxytyrosol

NCT ID: NCT01788670

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Water

Lemon-flavoured water (150 ml)

Group Type: PLACEBO_COMPARATOR

Water

Intervention Type: OTHER

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).

Group Type: ACTIVE_COMPARATOR

Ethanol

Intervention Type: DIETARY_SUPPLEMENT

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).

Group Type: ACTIVE_COMPARATOR

Ethanol

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Ethanol

Intervention Type: DIETARY_SUPPLEMENT

Water

Intervention Type: OTHER

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundacion IMIM

OTHER

Sponsor Role: collaborator

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magí Farré, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Parc de Salut Mar

Locations

Parc de Salut Mar

Barcelona, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 25801942 (View on PubMed)

Other Identifiers

Hidroxitirosol/FIS/1

Identifier Type: -

Identifier Source: org_study_id