Acute Effects of Jägermeister With Energy Drinks (Jägermbomb) (JB)

Fundació Institut Germans Trias i Pujol

Status: Enrolling

Conditions: Healthy Adult Participants; Energy Drinks; Binge Alcohol Consumption; Alcohol Drinking

Treatments: Dietary Supplement: Jägermeister and Energy Drink Placebo; Dietary Supplement: Alcohol Placebo and Energy Drink Placebo; Dietary Supplement: Jägermeister and Energy Drink (Jägerbomb)

Study type: Interventional

Funder types: Other

Identifiers

NCT07588022

HGTP/JB/PNSD/1

2024I013 (Other Identifier)

Details and patient eligibility

About

The main objective of this study is to compare the acute effects of drinking Jägerbombs with drinking alcohol alone during a binge-drinking episode, which involves consuming a large amount of alcohol in a short period of time to become intoxicated. Secondary objectives are to assess whether Jägerbombs produce prototypical alcohol effects, increase stimulation and rewarding effects, affect coordination, time reaction and vision, change stress-related hormone responses, and cause hangover symptoms.

Full description

Alcohol use is very common among young people in Spain. Binge drinking is a pattern of alcohol consumption that raises blood alcohol concentration (BAC) to 0.08% or higher (0.4 mg/L in breath air), typically defined as drinking 5 or more standard drinks for men or 4 or more for women within about 2 hours.This is a serious public health problem because it can cause illness, injuries, and even death.

Energy drinks (ED) are also widely used by young people and are often mixed with alcohol. People do this to hide the taste of alcohol or to feel less tired or drunk. However, ED do not reduce alcohol intoxication and are linked to more risky behavior. Research suggests that ED only slightly reduce some alcohol-related problems, such as slower reactions. This can give a false feeling of safety and make people more likely to drive while drunk.

One popular mixture is the Jägerbomb, a combination of Jägermeister liquor and energy drink (ED), but its effects have not been previously studied.

This study will be conducted as a randomized, double-blind, placebo-controlled trial in healthy adults who have experience consuming alcohol and caffeinated beverages.

A pilot study has been conducted in the first four participants (two women and two men) using a dose of 55 g of alcohol.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Men and women between 18-45 years old with a weight between 50-90 kg for men and between 55-80 kg for women, and a body mass index (BMI) between 19-28 kg/m2. Lower or higher weights or BMIs are allowed, in the opinion of the Principal Investigator or the collaborators designated by the Principal Investigator and that do not pose a risk to the subjects and do not interfere with the objectives of the study.
2. Alcohol consumption in the form of occasional binge drinking (≥1 time/month), social alcohol consumption (≥10g/day distributed weekly) and experience in alcohol intoxication.
3. Consumption ≥7 drinks with methylxanthines (coffee, tea, chocolate, cola, BE) per week and who have consumed ED on at least one occasion.
4. Understand and agree to the trial procedures and sign an informed consent.
5. History and physical examination that demonstrate no organic or psychiatric disorders.
6. The ECG and general blood and urine tests performed before the test should be within normal limits. Minor or punctual variations from the limits of normality are allowed if, at the discretion of the Principal Investigator, taking into account the state of science, they are not of clinical significance, do not pose a risk to the subjects and do not interfere with the assessment of the product. These variations and their non-relevance will be justified in writing in a specific way.

Exclusion criteria

1. Not meeting the inclusion criteria.
2. History or clinical evidence of gastrointestinal, liver, renal or other disorders that may involve an alteration in the absorption, distribution, metabolism or excretion of the drug, or that are suggestive of gastrointestinal irritation by drugs.
3. Current history of substance use disorder according to DSM-V (except nicotine). A previous history of mild substance use disorder (corresponding to substance abuse according to DSM-IV criteria) is admitted.
4. History or clinical evidence of psychiatric disorders, alcoholism, abuse of drugs or other drugs or habitual consumption of psychoactive drugs.
5. Have participated in clinical trials with drugs or nutraceuticals in the previous 12 weeks.

5) Have suffered any organic disease or major surgery in the three months prior to the start of the study.

6) Subjects who have an intolerance or have had serious adverse reactions to alcohol. The inclusion of subjects of oriental origin who do not have an intolerance to alcohol will be allowed.

7) Have taken medication regularly in the month prior to the study sessions, with the exception of vitamins, herbal remedies, or dietary supplements that, in the judgment of the Principal Investigator or collaborators designated by the Principal Investigator, do not pose a risk to the subjects and do not interfere with the objectives of the study. Treatment with single doses of symptomatic medication in the week prior to study sessions will not be grounds for exclusion if it is assumed to have been completely eliminated on the day of the experimental session.

8) Smokers of >5 cigarettes a day. 9) Consumption of more than 20 g of alcohol daily in women and more than 40 g in men.

10) Consumers of more than 5 coffees, teas, colas, or other stimulant or xanthine beverages daily in the 3 months prior to the start of the study.

11) Subjects who are not able to understand the nature of the trial and the procedures they are asked to follow.

12) Subjects with positive serology for hepatitis B, C or HIV. 13) Women who are pregnant or breastfeeding, or who use hormonal contraceptives or do not use reliable contraceptive measures during the study (such as abstinence, intrauterine devices, barrier methods or with a vasectomized partner).

14) Women with amenorrhea or premenstrual syndrome of severe intensity.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

Alcohol (Jägermeister) and Energy Drink: Jägerbomb

Experimental group

Description:

The total volume of drink is 821 mL in women and 875 mL in men, and is divided into 5 doses simulating a binge pattern, administered every 10 min (total time 45 minutes). Women: Jägermeister 196 mL (ethanol 55 g) + ED 625 ml (200 mg caffeine). Men: Jägermeister 250 mL (ethanol 70 g) + ED 625 ml (200 mg caffeine)

Treatment:

Dietary Supplement: Jägermeister and Energy Drink (Jägerbomb)

Alcohol (Jägermeister) and Energy Drink Placebo

Active Comparator group

Description:

The total volume of drink is 821 mL in women and 875 mL in men, and is divided into 5 doses simulating a binge pattern, administered every 10 min (total time 45 minutes). Women: Jägermeister 196 mL (55 g of ethanol) + placebo ED (a non-caffeinated soft drink) 625 mL. Men: Jägermeister 250 mL (70 g) + placebo ED (a non-caffeinated soft drink) 625 mL.

Treatment:

Dietary Supplement: Jägermeister and Energy Drink Placebo

Alcohol placebo and Energy Drink Placebo

Placebo Comparator group

Description:

The total volume of drink is 821 mL in women and 875 mL in men, and is divided into 5 doses simulating a binge pattern, administered every 10 min (total time 45 minutes). Women: Ethanol placebo (water) + ED placebo (a non-caffeinated soft drink) 625 mL. Men: Ethanol placebo (water) + ED placebo (a non-caffeinated soft drink) 625 mL.

Treatment:

Dietary Supplement: Alcohol Placebo and Energy Drink Placebo