Clinical trial NCT04183842: Evaluation of a Fixed Combination of Herbal Extracts to Prevent Symptoms Alcohol-induced Hangovers
Official title: Evaluation of a Fixed Combination of Herbal Extracts to Prevent Symptoms Alcohol-induced Hangovers : A Randomized, Double Blind Placebo Controlled Crossover Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Nausea
Dizziness
Sleepiness
Anxiety
Thirst
Lead sponsor: Incara Lab
Sponsor class: INDUSTRY
Collaborators: name: Phytomed AB
First posted: 2019-12-03
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double blind, placebo controlled, crossover study.
Primary purpose: PREVENTION

Brief summary: The primary objective of the study is to test whether the tested Product LACIME Anti-hangover is effective in preventing the signs and symptoms of alcohol-induced hangover (such as headache, impaired memory, depression, anxiety, weakness, trouble sleeping and concentrating, nausea, dizziness, sleepiness, thirsty, dry mouth, sweating, sensitivity to light and sounds, vision problems) in healthy subjects.

Detailed description: LACIME Anti-hangover is a food supplement under the form of a syrup (water/glycerin based) containing plan extracts, each one having choleretic properties.

40 healthy subjects will be tested in a randomized, double-blind, placebo-controlled, crossover trial.

The participants will have to attend the 2 phases of the study during which they will receive in a blind way a product (LACIME Anti-hangover or PLACEBO):

If a participant has received LACIME Anti-hangover for Phase 1, the same participant will receive the PLACEBO for Phase 2 and vice versa.

Inclusion Criteria:

For inclusion in the study subjects must fulfil all the following criteria:

20-30 years old healthy males and females, Body weight (kg): 60 - 80 in man and 60-70 in women, People who consume alcohol occasionally and who already have to deal with hangovers Healthy volunteers who consume alcohol regularly and moderately, Having given their free, informed and express consent in writing Co-operative, informed of the need and duration of the controls which make it possible to achieve full adherence to the protocol in place.

Exclusion Criteria:

Excluded from participating in the study:

Volunteers consuming larger amounts of alcohol (more than 2 glasses of alcohol per day) Volunteers taking medication or food supplements that may affect alcohol metabolism.

Women who are pregnant or breastfeeding or plan to become pregnant during the study Subjects with illnesses which may conflict with the investigator's interpretation, if the subject participated in the study Subject planning to change his/her lifestyle during the study (diet, physical activity, etc.) Smoker Subject participating in another study during the clinical study period.

* At the first medical visit all volunteers will be checked for illegibility, randomized, and sign written informed consent including an obligation that they will not take alcohol within the next week and come to the study site a week later at least 3 hours after the last meal.
* At the second visit, participants will attend the study site, where each will fill Hangover Severity Symptoms (HSS) form, donate blood and urine for initial analysis.

Then participants take the Product LACIME Anti-hangover or PLACEBO and after 1hour will start to consume alcohol during two hours with meal (3 sandwiches with cheese or ham) on each of the 2 study phases.

Drink consumption, the composition and sequence:

300 ml of Brandy (41% vol. alcohol) corresponding to an intake of 123 ml or 99 g of alcohol 300 ml of Champagne (13% vol. alcohol) corresponding to an intake of 40 ml or 32 g of alcohol This will ensure a 100% hangover syndrome and a total intake of 131 g of alcohol (a dose of approximately 2 g / kg).

Such a dose will provide a peak concentration after 1 hour and should allow to determine the alcohol 15 hours after absorption.

Smaller doses are usually not detectable after 10-12 hours. (Jones, 2008).

D2 test, blood sampling and urine sampling under medical control is achieved before alcohol intake.

D2 test, blood sampling and urine sampling under medical control is achieved 1h, 4h and 15h after alcohol consumption.

Eligibility criteria: Inclusion Criteria:

* 20-30 years old healthy males,
* Body weight (kg): 60 kg - 80 kg in man,
* People who consume alcohol occasionally,
* People who already had to deal with hangovers,
* Healthy volunteers who consume alcohol regularly and moderately,
* Having given their free, informed and express consent in writing,
* Co-operative, informed of the need and duration of the controls which make it possible to achieve full adherence to the protocol in place.

Exclusion Criteria:

* Volunteers consuming larger amounts of alcohol (more than 2 glasses of alcohol per day)
* Volunteers taking medication or food supplements that may affect alcohol metabolism,
* Subjects with illnesses which may conflict with the investigator's interpretation, if the subject participated in the study,
* Subject planning to change his lifestyle during the study (diet, physical activity, etc.)
* Subject participating in another study during the clinical study period.

Primary outcomes:
measure: Evaluation of the difference in Hangover Severity Scores between the activity of LACIME Anti-hangover and the activity of PLACEBO.
timeFrame: Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)
Secondary outcomes:
measure: Evaluation of the difference in Cognitive Performance Score between the activity of LACIME Anti-hangover and the activity of PLACEBO according to "d2" psychometric test.
timeFrame: Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)
measure: Acetaldehyde blood assay (Jones, 2008)
timeFrame: Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)
Other outcomes:
Locations:
city: Abovyan
country: Armenia
facility: Unimed Medical Center
state: Yerevan
Study officials:
affiliation: Swedish Herbal Institute AB
name: Alexander PANOSSIAN, Pr., Dr
role: STUDY_CHAIR
affiliation: Head od National Anti-Doping Organization
name: Areg HOVHANNISYAN, PhD, Dr.Sci
role: STUDY_DIRECTOR
affiliation: CARDIOMED Family Health Center
name: Artur POTOSSIAN, Dr. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CARDIOMED Family Health Center
name: Samvel HAYRUMYAN, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aziz AM, Brothers S, Sartor G, Holm L, Heilig M, Wahlestedt C, Thorsell A. The nociceptin/orphanin FQ receptor agonist SR-8993 as a candidate therapeutic for alcohol use disorders: validation in rat models. Psychopharmacology (Berl). 2016 Oct;233(19-20):3553-63. doi: 10.1007/s00213-016-4385-8. Epub 2016 Aug 11.
citation: Economidou D, Cippitelli A, Stopponi S, Braconi S, Clementi S, Ubaldi M, Martin-Fardon R, Weiss F, Massi M, Ciccocioppo R. Activation of brain NOP receptors attenuates acute and protracted alcohol withdrawal symptoms in the rat. Alcohol Clin Exp Res. 2011 Apr;35(4):747-55. doi: 10.1111/j.1530-0277.2010.01392.x. Epub 2011 Jan 11.
citation: Jayawardena R, Thejani T, Ranasinghe P, Fernando D, Verster JC. Interventions for treatment and/or prevention of alcohol hangover: Systematic review. Hum Psychopharmacol. 2017 Sep;32(5). doi: 10.1002/hup.2600. Epub 2017 May 31.
citation: Kim H, Kim YJ, Jeong HY, Kim JY, Choi EK, Chae SW, Kwon O. A standardized extract of the fruit of Hovenia dulcis alleviated alcohol-induced hangover in healthy subjects with heterozygous ALDH2: A randomized, controlled, crossover trial. J Ethnopharmacol. 2017 Sep 14;209:167-174. doi: 10.1016/j.jep.2017.07.028. Epub 2017 Jul 24.
citation: Lee HS, Isse T, Kawamoto T, Baik HW, Park JY, Yang M. Effect of Korean pear (Pyruspyrifolia cv. Shingo) juice on hangover severity following alcohol consumption. Food Chem Toxicol. 2013 Aug;58:101-6. doi: 10.1016/j.fct.2013.04.007. Epub 2013 Apr 13.
citation: Lee MH, Kwak JH, Jeon G, Lee JW, Seo JH, Lee HS, Lee JH. Red ginseng relieves the effects of alcohol consumption and hangover symptoms in healthy men: a randomized crossover study. Food Funct. 2014 Mar;5(3):528-34. doi: 10.1039/c3fo60481k.
citation: Pittler MH, White AR, Stevinson C, Ernst E. Effectiveness of artichoke extract in preventing alcohol-induced hangovers: a randomized controlled trial. CMAJ. 2003 Dec 9;169(12):1269-73.
citation: Robertson BM, Piasecki TM, Slutske WS, Wood PK, Sher KJ, Shiffman S, Heath AC. Validity of the hangover symptoms scale: evidence from an electronic diary study. Alcohol Clin Exp Res. 2012 Jan;36(1):171-7. doi: 10.1111/j.1530-0277.2011.01592.x. Epub 2011 Jul 18.
citation: Slutske WS, Piasecki TM, Hunt-Carter EE. Development and initial validation of the Hangover Symptoms Scale: prevalence and correlates of Hangover Symptoms in college students. Alcohol Clin Exp Res. 2003 Sep;27(9):1442-50. doi: 10.1097/01.ALC.0000085585.81711.AE.
citation: Wiese J, McPherson S, Odden MC, Shlipak MG. Effect of Opuntia ficus indica on symptoms of the alcohol hangover. Arch Intern Med. 2004 Jun 28;164(12):1334-40. doi: 10.1001/archinte.164.12.1334.