Contribution of Wine Components on Hydroxytyrosol Body Concentrations and Biological Effects

NCT01790672 | Completed Phase 1

• 1 other identifier: Hydroxytyrosol/FIS/2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study is aimed at establishing the contribution of wine components on hydroxytyrosol body concentrations and biological effects.

Conditions

Contribution of Wine Components in Hydroxytyrosol Formation

Keywords

Antioxidants; Central Nervous System Agents; Wine

Outcome Measures

Primary Outcomes (1)

• Hydroxytyrosol biological fluids concentrations

  Hydroxytyrosol concentrations in plasma and urine

  0-24h after administration

Secondary Outcomes (10)

• Ethanol concentration

  0-6h after administration

• Subjective drunkenness

  0-6h after administration

• Vital signs

  0-24h after administration

• Ethanol metabolites concentrations

  0-24h after administration

• Dopamine metabolites concentrations

  0-24h after administration

Study Arms (4)

Water

PLACEBO COMPARATOR

Lemon-flavored water. 293 ml in pilot A, 147 ml in pilot B, 235 ml in pilot C, 147 ml in the definitive study.

Other: Water

Alcoholized wine

ACTIVE COMPARATOR

Wine 13º in pilot A (293 ml), B (147 ml) and the definitive study (147 ml). Corresponding to 30 g of ethanol in pilot A, 15 g of ethanol in pilot B and 15 g of ethanol in the definitive study. Wine 8º in pilot C (235 ml). Corresponding to 15 g of ethanol.

Dietary Supplement: Alcoholized wine

De-alcoholized wine

PLACEBO COMPARATOR

Wine 0º. Pilot A: 293ml; pilot B: 147 ml; pilot C: 235 ml; definitive study: 147 ml. Corresponding to 0 g of ethanol.

Dietary Supplement: De-alcoholized wine

Ethanol

ACTIVE COMPARATOR

Ethanol 13º in pilot A (293 ml), B (147 ml) and definitive study (147 ml). Corresponding to 30 g of ethanol in pilot A, 15 g of ethanol in pilot B and in the definitive study. Ethanol 8º in pilot C (235 ml). Corresponding to 15 g of ethanol. Ethanol was administered as a single dose of Vodka Absolut (40º) diluted in lemon-flavored water.

Dietary Supplement: Ethanol

Interventions

Ethanol DIETARY_SUPPLEMENT

Vodka Absolut

Ethanol

Water OTHER

Lemon-flavored water

Water

Alcoholized wine DIETARY_SUPPLEMENT

Wine 13º or wine 8º

Alcoholized wine

De-alcoholized wine DIETARY_SUPPLEMENT

Wine 0º

De-alcoholized wine

Eligibility Criteria

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

You may qualify if:

• Understanding and accepting the study procedures and signing the informed consent.
• Male and female volunteers aged 18 to 55 years. No fixed sex ratio has been established.
• 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 25 kg/m2, and the weight from 50 to 100 kg. 25-27 could be accepted.
• Women with regular menstrual cycle of 26-32 days.
• Subjects socially drinking and who had ingested wine at least once.

You may not qualify if:

• 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.
• History or clinical evidence of psychiatric disorders, alcoholism, drug abuse, or regular use of psychoactive drugs.
• Blood donation in the previous 8 weeks or participation in other clinical trials with drugs in the previous 12 weeks.
• Having suffered any organic disease or major surgery in the three months prior to the study start.
• Subjects with intolerance or serious adverse reactions to ethanol.
• Taking more than 20 g of alcohol a day in women and more than 30 g in men.
• Taking more than 5 coffees, teas, cola drinks or other stimulating drinks or with xanthines daily in the 3 months prior to the study start.
• Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
• Smokers or ex-smokers of less than one year.
• Subjects with positive serology to Hepatitis B, C or HIV.
• Pregnant or nursing women or positive pregnancy test in urine. Women not undertaking to follow reliable contraceptive measures during the study (such as abstinence, hormonal contraceptives, intrauterine devices, double-barrier methods or vasectomised partner).
• Women with amenorrhea or premenstrual syndrome of moderate or severe intensity.
• Nonsteroidal anti-inflammatory drugs, antioxidants or vitamins consumption in the last 2 weeks.
• Total cholesterol \>6.00 mmol/l (240 mg/dl) or triglycerides \>2.26 mmol/l (200 mg/dl).
• Vegetarians or subjects following aberrant diets.

Sponsors & Collaborators

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

Study Sites (1)

Parc de Salut Mar

Barcelona, Barcelona, 08003, Spain

Location

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 11, 2013
• First Posted: February 13, 2013
• Study Start: May 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

ES (1)