Status:
COMPLETED
Interaction Between a Natural Aldehyde Dehydrogenase 2 (ALDH2) Inhibitor and Alcohol
Lead Sponsor:
Parc de Salut Mar
Collaborating Sponsors:
Ministerio de Sanidad, Servicios Sociales e Igualdad
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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.
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 impl...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02309801
Start Date
July 1 2012
End Date
November 1 2014
Last Update
December 5 2014
Active Locations (1)
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1
Parc de Salut Mar.
Barcelona, Barcelona, Spain, 08003