Contribution of Wine Components in Hydroxytyrosol FormationPhase 1NCT01790672
Contribution of Wine Components on Hydroxytyrosol Body Concentrations and Biological Effects
A Phase 1 study testing Ethanol, Water and Alcoholized wine in people with Contribution of Wine Components in Hydroxytyrosol Formation, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The study is aimed at establishing the contribution of wine components on hydroxytyrosol body concentrations and biological effects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Contribution of Wine Components in Hydroxytyrosol Formation
- What is being tested?
- Ethanol, Water and Alcoholized wine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- May 2011to Sep 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Ethanol, Water, Alcoholized wine, De-alcoholized wine
- Keywords
- Antioxidants, Central Nervous System Agents, Wine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthanolDietary supplement
Vodka Absolut
WaterOther
Lemon-flavored water
Alcoholized wineDietary supplement
Wine 13º or wine 8º
De-alcoholized wineDietary supplement
Wine 0º
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydroxytyrosol biological fluids concentrations
Hydroxytyrosol concentrations in plasma and urine
Measured: 0-24h after administration
Secondary outcomes (10)
Ethanol concentration
Ethanol blood concentrations
Measured: 0-6h after administration
Subjective drunkenness
Ethanol subjective effects measured using a visual analog scale
Measured: 0-6h after administration
Vital signs
Blood pressure, oral temperature and heart rate
Measured: 0-24h after administration
Ethanol metabolites concentrations
Ethanol metabolites recovery in urine
Measured: 0-24h after administration
Dopamine metabolites concentrations
Dopamine metabolites recovery in urine
Measured: 0-24h after administration
Oxidation biomarkers of proteins and lipids
Measured: 0-24h after administration
Psychomotor performance (DSST)
Psychomotor performance assessed by means of Digit symbol substitution test (DSST)
Measured: 0-6h after administration
Gene expression of genes related with receptors and regulators/oxidative stress and antioxidant defence
Measured: Baseline
Platelets monoamine oxidase-B activity
Measured: Baseline
Breath ethanol
Breath ethanol concentration
Measured: 30 min after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startMay 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contribution of Wine Components in Hydroxytyrosol FormationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion IMIM
- Responsible party
- Sponsor
- Investigators
- Magí Farré, MD, PhD, Principal investigator, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790672
- Sponsor's protocol ID
- Hydroxytyrosol/FIS/2
- Status last verified
- Jul 2014
- First submitted
- 11 Feb 2013
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01790672
- Acronym / sponsor ID
- Hydroxytyrosol/FIS/2
- Keywords
- Antioxidants, Central Nervous System Agents, Wine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Fundacion IMIM
- Study start
- May 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is aimed at establishing the contribution of wine components on hydroxytyrosol body concentrations and biological effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Water | Placebo comparator | Other: WaterLemon-flavored water. 293 ml in pilot A, 147 ml in pilot B, 235 ml in pilot C, 147 ml in the definitive study. |
| Alcoholized wine | Active comparator | Dietary Supplement: Alcoholized wineWine 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. |
| De-alcoholized wine | Placebo comparator | Dietary Supplement: De-alcoholized wineWine 0º. Pilot A: 293ml; pilot B: 147 ml; pilot C: 235 ml; definitive study: 147 ml. Corresponding to 0 g of ethanol. |
| Ethanol | Active comparator | Dietary Supplement: EthanolEthanol 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EthanolVodka Absolut | Dietary supplement | Ethanol |
| WaterLemon-flavored water | Other | Water |
| Alcoholized wineWine 13º or wine 8º | Dietary supplement | Alcoholized wine |
| De-alcoholized wineWine 0º | Dietary supplement | De-alcoholized wine |
Primary outcome
Hydroxytyrosol biological fluids concentrations
Time frame: 0-24h after administration
Hydroxytyrosol concentrations in plasma and urine
10 secondary outcomes
Ethanol concentration
Time frame: 0-6h after administration
Subjective drunkenness
Time frame: 0-6h after administration
Vital signs
Time frame: 0-24h after administration
Ethanol metabolites concentrations
Time frame: 0-24h after administration
Dopamine metabolites concentrations
Time frame: 0-24h after administration
Oxidation biomarkers of proteins and lipids
Time frame: 0-24h after administration
Psychomotor performance (DSST)
Time frame: 0-6h after administration
Gene expression of genes related with receptors and regulators/oxidative stress and antioxidant defence
Time frame: Baseline
Platelets monoamine oxidase-B activity
Time frame: Baseline
Breath ethanol
Time frame: 30 min after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magí Farré, MD, PhD principal investigator
Parc de Salut Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ethanol, Water and Alcoholized wine in people with Contribution of Wine Components in Hydroxytyrosol Formation, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydroxytyrosol biological fluids concentrations (time frame: 0-24h after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.