Acute Effects of Jägermeister With Energy Drinks (Jägermbomb)

Официальное название

Acute Effects of an Explosive Cocktail With Energy Drinks That is Trendy Among Young People, the Jägerbomb

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Jägermeister and Energy Drink (Jägerbomb)
  Multiple oral dose of Jägermeister mixed with ED
• Пищевая добавка Jägermeister and Energy Drink Placebo
  Multiple oral dose of Jägermeister mixed with a placebo of ED (non-caffeinated soft drink)
• Пищевая добавка Alcohol Placebo and Energy Drink Placebo
  Multiple oral dose of alcohol placebo (water) mixed with ED placebo (non-caffeinated soft drink)

Первичные конечные точки

• Change in reaction time (Psychomotor Vigilance Task) [Срок оценки: From baseline to 4 hours after administration]

Вторичные конечные точки (12)

• Maximum concentration (Cmax) of ethanol in breath air [Срок оценки: From baseline to 8 hours after administration]
• Maximum concentration (Cmax) of caffeine in oral fluid [Срок оценки: From baseline to 6 hours after administration]
• Area under the concentration-time curve (AUC 0-8h) of ethanol breath concentrations [Срок оценки: From baseline to 8 hours after administration]
• Area under the concentration-time curve (AUC 0-6h) of caffeine oral fluid concentrations [Срок оценки: From baseline to 6 hours after administration]
• Time to reach maximum concentration (tmax) of ethanol in breath air [Срок оценки: From baseline to 8 hours after administration]
• Time to reach maximum concentration (tmax) of caffeine in oral fluid [Срок оценки: From baseline to 6 hours after administration]
• Maximum concentration (Cmax) of cortisol in oral fluid [Срок оценки: From baseline till 6 hours after administration]
• Time to reach maximum concentration (tmax) of saliva in oral fluid [Срок оценки: From baseline to 6 hours after administration]
• Area under the concentration-time curve (AUC 0-6h) of cortisol concentrations in oral fluid [Срок оценки: From baseline till 6 hours after administration]
• Change in visual acuity [Срок оценки: From baseline to 4 hours after administration]
• Change in unstable tracking task [Срок оценки: From baseline to 4 hours after administration]
• Change in pupillary diameter [Срок оценки: From baseline to 4 hours after administration]

Критерии участия

Критерии включения

• 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.
• Alcohol consumption in the form of occasional binge drinking (≥1 time/month), social alcohol consumption (≥10g/day distributed weekly) and experience in alcohol intoxication.
• Consumption ≥7 drinks with methylxanthines (coffee, tea, chocolate, cola, BE) per week and who have consumed ED on at least one occasion.
• Understand and agree to the trial procedures and sign an informed consent.
• History and physical examination that demonstrate no organic or psychiatric disorders.
• 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.

Критерии исключения

• Not meeting the inclusion criteria.
• 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.
• 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.
• History or clinical evidence of psychiatric disorders, alcoholism, abuse of drugs or other drugs or habitual consumption of psychoactive drugs.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Испания · 1 центр

• Hospital Universitari Germans Trias i Pujol-IGTP — Barcelona

Публикации

• Mets MA, Ketzer S, Blom C, van Gerven MH, van Willigenburg GM, Olivier B, Verster JC. Positive effects of Red Bull(R) Energy Drink on driving performance during prolonged driving. Psychopharmacology (Berl). 2011 Apr;214(3):737-45. doi: 10.1007/s00213-010-2078-2. Epub 2010 Nov 10. PMID 21063868
• White WL. Erratum to: Why I hate the index finger. Hand (N Y). 2011 Jun;6(2):233. doi: 10.1007/s11552-011-9321-0. Epub 2011 Mar 18. PMID 21776199
• Redondo B, Vera J, Carreno-Rodriguez C, Molina-Romero R, Jimenez R. Acute Effects of Caffeine on Dynamic Accommodative Response and Pupil Size: A Placebo-controlled, Double-blind, Balanced Crossover Study. Curr Eye Res. 2020 Sep;45(9):1074-1081. doi: 10.1080/02713683.2020.1725060. Epub 2020 Feb 11. PMID 32011181
• McKetin R, Coen A, Kaye S. A comprehensive review of the effects of mixing caffeinated energy drinks with alcohol. Drug Alcohol Depend. 2015 Jun 1;151:15-30. doi: 10.1016/j.drugalcdep.2015.01.047. Epub 2015 Feb 24. PMID 25861944
• Liguori A, Robinson JH. Caffeine antagonism of alcohol-induced driving impairment. Drug Alcohol Depend. 2001 Jul 1;63(2):123-9. doi: 10.1016/s0376-8716(00)00196-4. PMID 11376916
• Garrisson H, Scholey A, Verster JC, Shiferaw B, Benson S. Effects of alcohol intoxication on driving performance, confidence in driving ability, and psychomotor function: a randomized, double-blind, placebo-controlled study. Psychopharmacology (Berl). 2022 Dec;239(12):3893-3902. doi: 10.1007/s00213-022-06260-z. Epub 2022 Nov 2. PMID 36322184
• Howland J, Rohsenow DJ, Arnedt JT, Bliss CA, Hunt SK, Calise TV, Heeren T, Winter M, Littlefield C, Gottlieb DJ. The acute effects of caffeinated versus non-caffeinated alcoholic beverage on driving performance and attention/reaction time. Addiction. 2011 Feb;106(2):335-41. doi: 10.1111/j.1360-0443.2010.03219.x. Epub 2010 Dec 6. PMID 21134017
• Perez-Mana C, Mateus JA, Diaz-Pellicer P, Diaz-Baggerman A, Perez M, Pujadas M, Fonseca F, Papaseit E, Pujol J, Langohr K, de la Torre R. Effects of Mixing Energy Drinks With Alcohol on Driving-Related Skills. Int J Neuropsychopharmacol. 2022 Jan 12;25(1):13-25. doi: 10.1093/ijnp/pyab051. PMID 34338762

Идентификаторы

NCT: NCT07588022 · HGTP/JB/PNSD/1 · 2024I013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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