Contribution of Wine Components on Hydroxytyrosol Body Concentrations and Biological Effects

Hydroxytyrosol as an Endogenous and Natural Antioxidant: Modulation by Alcohol Intake. Substudy 2. To Establish the Contribution of Wine Components on Hydroxytyrosol Body Concentrations and Biological Effects

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

Study Overview

• Status: Completed
• Conditions: Contribution of Wine Components in Hydroxytyrosol Formation
• Intervention / Treatment: Other: Water; Dietary supplement: Alcoholized wine; Dietary supplement: De-alcoholized wine; Dietary supplement: Ethanol

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Parc de Salut Mar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Not meeting the inclusion criteria.
• 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.
• Regular use of any drug in the month prior to the study sessions, except for vitamins or diet supplements, that, in the opinion of the principal investigator or co-investigators designated by him, do not involve a risk for the subject and do not interfere with the study objectives. In this case they should be discontinued from one week before the experimental sessions to the end of them. 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.
• 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.
• Physical exercise of >2h/day or >3000 kcal /week.

To be eligible, the subjects must agree to follow a poor polyphenols diet in the 72 hours prior to the start of each session and until 24 hours after.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Water; 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; Lemon-flavored water
Active Comparator: Alcoholized wine; 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; Wine 13º or wine 8º
Placebo Comparator: De-alcoholized wine; 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; Wine 0º
Active Comparator: Ethanol; 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; Vodka Absolut

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hydroxytyrosol biological fluids concentrations	Hydroxytyrosol concentrations in plasma and urine	0-24h after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective drunkenness	Ethanol subjective effects measured using a visual analog scale	0-6h after administration
Ethanol concentration	Ethanol blood concentrations	0-6h after administration
Ethanol metabolites concentrations	Ethanol metabolites recovery in urine	0-24h after administration
Dopamine metabolites concentrations	Dopamine metabolites recovery in urine	0-24h after administration
Vital signs	Blood pressure, oral temperature and heart rate	0-24h after administration
Oxidation biomarkers of proteins and lipids		0-24h after administration
Psychomotor performance (DSST)	Psychomotor performance assessed by means of Digit symbol substitution test (DSST)	0-6h after administration
Gene expression of genes related with receptors and regulators/oxidative stress and antioxidant defence		Baseline
Platelets monoamine oxidase-B activity		Baseline
Breath ethanol	Breath ethanol concentration	30 min after administration

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Collaborators: Fundacion IMIM
• Investigators: Principal Investigator: Magí Farré, MD, PhD, Parc de Salut Mar

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: February 11, 2013
• First Submitted That Met QC Criteria: February 11, 2013
• First Posted (Estimate): February 13, 2013

Study Record Updates

• Last Update Posted (Estimate): July 24, 2014
• Last Update Submitted That Met QC Criteria: July 23, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Antioxidants; Central Nervous System Agents; Wine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: Hydroxytyrosol/FIS/2