HealthyPhase 1COCADEP/2NCT02309801
Interaction Between a Natural Aldehyde Dehydrogenase 2 (ALDH2) Inhibitor and Alcohol
A Phase 1 study testing Daidzin and Alcohol in people with Healthy, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The main objective is to assess whether a natural inhibitor of aldehyde dehydrogenase 2 (ALDH2) contained in a soy extract could interfere on alcohol metabolism and effects in humans. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Daidzin and Alcohol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2012to Nov 2014
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understanding and accepting the study procedures and signing the informed consent
- 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 100 kg
- Ethanol consumption of minimum 2 units per week and previous experience with ethanol intoxication
- Women with regular menstrual cycle (26-32 days)
Who cannot join
- Not meeting the inclusion criteria
- History or clinical evidence of alcoholism, psychiatric disorders, drug abuse or dependence, or regular use of psychoactive drugs
- Having suffered any organic disease or major surgery in the three months prior to the study start
- Smokers
- Consumption of more than five coffees, teas, colas, other stimulant or xanthine beverages daily in the three months prior to the beginning of the study
- Taking more than 20 g of alcohol per day in women and 40 g of alcohol per day in men
Show all 14Show fewer
- 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 allergy, intolerance or adverse reactions to alcohol, soya and lactose.
- 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
- Pregnant or breastfeeding women. Women not using effective contraceptive methods
- History or presence of breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Pharmacology Study to Evaluate the Interaction Between a Natural Inhibitor of Aldehyde Dehydrogenase 2 (ALDH2) and Alcohol in Healthy Volunteers. Pilot Clinical Trial
The main objective is to assess whether a natural inhibitor of aldehyde dehydrogenase 2 (ALDH2) contained in a soy extract could interfere on alcohol metabolism and effects in humans.
Read the detailed description
Soybeans contain isoflavones, which are biologically active polyphenols known as antioxidants and phytoestrogens. These isoflavones include daidzin, daidzein, genistin and glycitin, and have been implicated in the beneficial effects of soy consumption.
Daidzin and daidzein are isoflavones contained in soybean that can act as natural inhibitors of aldehyde dehydrogenase 2. Animal studies have demonstrated that some soy isoflavones can reduce the auto-administration of cocaine and suggest they might be useful to treat cocaine dependence.
Aldehyde dehydrogenase inhibitors, as disulfiram, are currently used in humans to treat alcohol dependence because they interfere with ethanol metabolism (specifically in the transformation of acetaldehyde to acetate.
Alcohol intake after disulfiram administration increases concentration of acetaldehyde in the blood (five to 10 times higher than that found during metabolism of the same amount of alcohol alone). The combination produced acute symptoms of a severe "hangover" (named disulfiram-like reaction), and the patient may experience symptoms as flushing of the skin, tachycardia, shortness of breath, nausea, vomiting, throbbing headache, visual disturbances, mental confusion, and in some cases severe reactions as postural syncope, and circulatory collapse.
In addition, disulfiram have demonstrated clinical efficacy in cocaine dependence. The mechanism of action for that effects are related to its ability to decrease dopamine degradation by inhibiting the dopamine-beta-hydroxylase enzyme (metabolizes dopamine to norepinephrine), and increasing its concentrations in some areas of the brain.
The aim of the study is to assess whether a soy extract containing isoflavones (daidzin, daidzein and genistein) could interfere on alcohol metabolism and produce adverse effects in humans.
- Conditions
- Healthy
- Being tested
- Daidzin, Alcohol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaidzinDietary supplement
Super-Absorbable Soy Isoflavones, LifeExtension, USA. Single oral dose of 4 capsules (containing 80 mg of daidzin-daidzein).
AlcoholDietary supplement
Alcohol single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Daidzin and alcohol | Experimental | Daidzin 80 mg, single dose, oral administration (4 capsules of Super-Absorbable Soy Isoflavones®).
Alcohol 0.5 g/kg (vodka diluted in lemon-flavoured water), single dose, oral administration. Solution of 150 ml. Receives: Dietary Supplement: Daidzin; Dietary Supplement: Alcohol |
| Alcohol | Active comparator | Alcohol 0.5 g/kg (vodka diluted in lemon-flavoured water), single dose, oral administration. Solution of 150 ml. Receives: Dietary Supplement: Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time curve (AUC 2-10h)
Calculation of AUC for blood alcohol concentrations
Measured: From 2h to 10h after the first administration
Secondary outcomes (8)
Change in signs and symptoms of disulfiram-like reaction
Vital signs (heart rate, blood pressure, respiration rate, oral and facial temperature) and adverse effects measured by visual analogue scales (nausea, vomiting, vertigo, dizziness, headache, breathing difficulty, facial flushing)
Measured: From baseline to 10h after the first administration
Change in drunkenness and euphoria effects
Drunkenness and euphoria will be measured by a visual analogue scale (VAS).
Measured: From baseline to 10h after the first administration
Area Under the Concentration-Time curve (AUC 0-10h)
Calculation of AUC of plasmatic concentrations of daidzein, genistein and equol
Measured: From baseline to 24h after the first administration
Number of participants with Serious and non-serious adverse events
Collection of adverse events spontaneously reported by the participants and/or observed by the investigators.
Measured: 3 days after each condition
Change in other subjective effects
Subjective effects will be measured with the Addiction Research Center Inventory (ARCI)
Measured: From baseline to 10h after the first administration
Elimination half-life
Calculation of elimination half-life from blood ethanol concentrations
Measured: From 2h to 10h after the first administration
Elimination half-life
Calculation of elimination half-life of plasmatic concentrations of daidzein, genistein and equol
Measured: From baseline to 24h after the first administration
Cumulative amount of drug excreted into urine up to collection time
Urine will be collected in the following periods:0-2h,2-8h,8-14h,14-24 h after administration. Concentrations of daidzein, genistein and equol will be measured
Measured: From baseline to 24h after the first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJul 2012
- Primary completionNov 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Sanidad, Servicios Sociales e Igualdad
- Responsible party
- Sponsor
- Investigators
- Magí Farré, MD, PhD, Principal investigator, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309801
- Sponsor's protocol ID
- PSMAR/IMIM/COCADEP/2
- Acronym
- COCADEP/2
- Status last verified
- Dec 2014
- First submitted
- 3 Dec 2014
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Pharmacology Study to Evaluate the Interaction Between a Natural Inhibitor of Aldehyde Dehydrogenase 2 (ALDH2) and Alcohol in Healthy Volunteers. Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT02309801
- Acronym / sponsor ID
- COCADEP/2 / PSMAR/IMIM/COCADEP/2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Ministerio de Sanidad, Servicios Sociales e Igualdad
- Study start
- Jul 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 Dec 2014 (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 main objective is to assess whether a natural inhibitor of aldehyde dehydrogenase 2 (ALDH2) contained in a soy extract could interfere on alcohol metabolism and effects in humans.
Detailed description
Soybeans contain isoflavones, which are biologically active polyphenols known as antioxidants and phytoestrogens. These isoflavones include daidzin, daidzein, genistin and glycitin, and have been implicated in the beneficial effects of soy consumption.
Daidzin and daidzein are isoflavones contained in soybean that can act as natural inhibitors of aldehyde dehydrogenase 2. Animal studies have demonstrated that some soy isoflavones can reduce the auto-administration of cocaine and suggest they might be useful to treat cocaine dependence.
Aldehyde dehydrogenase inhibitors, as disulfiram, are currently used in humans to treat alcohol dependence because they interfere with ethanol metabolism (specifically in the transformation of acetaldehyde to acetate.
Alcohol intake after disulfiram administration increases concentration of acetaldehyde in the blood (five to 10 times higher than that found during metabolism of the same amount of alcohol alone). The combination produced acute symptoms of a severe "hangover" (named disulfiram-like reaction), and the patient may experience symptoms as flushing of the skin, tachycardia, shortness of breath, nausea, vomiting, throbbing headache, visual disturbances, mental confusion, and in some cases severe reactions as postural syncope, and circulatory collapse.
In addition, disulfiram have demonstrated clinical efficacy in cocaine dependence. The mechanism of action for that effects are related to its ability to decrease dopamine degradation by inhibiting the dopamine-beta-hydroxylase enzyme (metabolizes dopamine to norepinephrine), and increasing its concentrations in some areas of the brain.
The aim of the study is to assess whether a soy extract containing isoflavones (daidzin, daidzein and genistein) could interfere on alcohol metabolism and produce adverse effects in humans.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daidzin and alcohol | Experimental | Dietary Supplement: Daidzin, Dietary Supplement: AlcoholDaidzin 80 mg, single dose, oral administration (4 capsules of Super-Absorbable Soy Isoflavones®). Alcohol 0.5 g/kg (vodka diluted in lemon-flavoured water), single dose, oral administration. Solution of 150 ml. |
| Alcohol | Active comparator | Dietary Supplement: AlcoholAlcohol 0.5 g/kg (vodka diluted in lemon-flavoured water), single dose, oral administration. Solution of 150 ml. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Understanding and accepting the study procedures and signing the informed consent
- 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 100 kg
- Ethanol consumption of minimum 2 units per week and previous experience with ethanol intoxication
Key exclusion criteria (14 listed)
- Not meeting the inclusion criteria
- History or clinical evidence of alcoholism, psychiatric disorders, drug abuse or dependence, or regular use of psychoactive drugs
- Having suffered any organic disease or major surgery in the three months prior to the study start
- Smokers
- Consumption of more than five coffees, teas, colas, other stimulant or xanthine beverages daily in the three months prior to the beginning of the study
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 |
|---|---|---|
| DaidzinSuper-Absorbable Soy Isoflavones, LifeExtension, USA. Single oral dose of 4 capsules (containing 80 mg of daidzin-daidzein). | Dietary supplement | Daidzin and alcohol |
| AlcoholAlcohol single oral dose | Dietary supplement | Alcohol, Daidzin and alcohol |
Primary outcome
Area Under the Concentration-Time curve (AUC 2-10h)
Time frame: From 2h to 10h after the first administration
Calculation of AUC for blood alcohol concentrations
8 secondary outcomes
Change in signs and symptoms of disulfiram-like reaction
Time frame: From baseline to 10h after the first administration
Change in drunkenness and euphoria effects
Time frame: From baseline to 10h after the first administration
Area Under the Concentration-Time curve (AUC 0-10h)
Time frame: From baseline to 24h after the first administration
Number of participants with Serious and non-serious adverse events
Time frame: 3 days after each condition
Change in other subjective effects
Time frame: From baseline to 10h after the first administration
Elimination half-life
Time frame: From 2h to 10h after the first administration
Elimination half-life
Time frame: From baseline to 24h after the first administration
Cumulative amount of drug excreted into urine up to collection time
Time frame: From baseline to 24h after the first 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 5 Dec 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Daidzin and Alcohol in people with Healthy, 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 6 inclusion and 14 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 5 Dec 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. 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?
Area Under the Concentration-Time curve (AUC 2-10h) (time frame: From 2h to 10h after the first 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 5 Dec 2014.