Measurement of alcohol concentration with a breathalyzer in healthy individuals after optimized food consumption.
- Conditions
- Healthy VolunteersClinical trialMental and behavioral disorders due to alcohol use - acute intoxicationAlcoholismF10.0
- Registration Number
- RBR-9wp48fj
- Lead Sponsor
- Ambev SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
• Understand the study procedures and voluntarily agree to participate in the study and sign the Informed Consent Form (FICF – Appendix 1);
• Men or non-pregnant women, non-lactating women, 25 to 55 years of age; body mass 20 - 30 kg / m2;
• Blood pressure: systolic <140 and diastolic <95 mmHg;
• Social (moderate) drinkers who drink an average of 2 or less drinks a day and have had no episodes of excessive alcohol consumption ” in the previous 30 days. Excessive alcohol consumption is defined as drinking 4 or more drinks (for women) / 5 or more drinks (for men) over 2 hours. A drink is defined as approximately 150 ml of wine, 341 ml of beer / cider or 45 ml of distilled 40% alcoholic strength;
• Willing to maintain a habitual diet, physical activity pattern and body weight throughout the test and consume standard meal provided by the research team on the evening before each test day;
• Willing to refrain from strenuous exercise, alcoholic beverages, and marijuana use 24 hours prior to study visits;
• Willing to refrain from driving or operating any vehicle when leaving the research laboratory after the testing visit;
• Willing to sign on each test day a statement acknowledging that the subject is aware that they consumed alcohol that morning (Appendix 2);
• Willing to maintain current dietary supplement use throughout the study. On test days, the subject agrees not to take any dietary supplements or caffeine. Failure to comply will result in a rescheduled test visit;
• No serious illness or surgery that requires hospitalization within 3 months of the first study visit following screening;
• No history of cardiovascular, metabolic, respiratory, renal, gastrointestinal, or liver disease;
• Absence of health conditions that prevent them from meeting the study requirements as judged by the investigator based on medical history;
• Women are willing to use a contraceptive method to prevent pregnancy during the study period, and willing to have a test of urine pregnancy on the day of each study.
• Failure to meet all inclusion criteria;
• Smoker;
• History of gastrointestinal, hepatic, renal, or cardiovascular disease (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke) and lung disease;
• History of mental illness, seizures, use or abuse of psychoactive medications (including but not limited to cocaine, amphetamines, opiates, sedatives, benzodiazepines and hallucinogens) or any medication or condition that could make participation dangerous to the subject or to others, or affect the results;
• Use of antibiotics in the 4 weeks prior to the start of the study;
• History or diagnosis of alcohol use disorder or binge drinking (4 or more drinks for women and 5 or more drinks for men within a 2-hour window);
• Severe trauma or surgical event within 3 months of screening;
• Of Eastern descent or with a history of alcohol-induced flushing reaction;
• Reluctance or inability to comply with experimental procedures;
• Known intolerance, sensitivity, or allergy to any study product ingredients;
• Extreme dietary habits, as judged by the investigator (ie Atkins diet, very high protein diets, etc.);
• Change in body weight of >3.5 kg within 4 weeks after the screening appointment;
• Presence of any signs or symptoms of active infection in the 5 days prior to any test visit. If an infection occurs during the study period, testing visits should be rescheduled until all signs and symptoms have resolved and any treatment (ie antibiotic therapy) has been completed at least 5 days prior to each visit. test.
• History of cancer within the last two years, except for non-melanoma skin cancer.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of alcohol content of patients who consumed the optimized food.
- Secondary Outcome Measures
Name Time Method The alcoholic concentration found in individuals differs if alcohol is administered in the fasted state or fed state.