Evaluation of a Fixed Combination of Herbal Extracts to Prevent Symptoms Alcohol-induced Hangovers
Condition: Headache; Nausea; Dizziness; Sleepiness; Anxiety; Thirst
MeSH terms: Headache; Sleepiness; Dizziness
Study type: Interventional

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.
    

Intervention name(s): LACIME Anti-hangover; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): LACIME Anti-hangover contains the following excipients:
Purified water,
Xanthan gum,
Glycerin,
Potassium sorbate (as a preservative)
Citric acid (acidity regulator)
Aroma (flavouring agent)
LACIME Anti-hangover contains the following plant extracts and vitamin:
Curcuma longa rhizome extract (Curcuma),
Panax quinquefolius extract (Ginseng panax),
Malpighia punicifolia extract (Acerola),
Silybum marianum extract (Milk thistle),
Desmodium adscendens extract (Desmodium),
Pyridoxine chlorhydrate (Vitamin B6).; Placebo contains the following excipients :
Purified water,
Xanthan gum,
Glycerin,
Potassium sorbate (as a preservative)
Citric acid (acidity regulator)
Aroma (flavouring agent)
Placebo contains :
- Carrot juice
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double blind, placebo controlled, crossover study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention