Evaluation of a Fixed Combination of Herbal Extracts to Prevent Symptoms Alcohol-induced Hangovers (LACIME)

November 28, 2019 updated by: Incara Lab

Evaluation of a Fixed Combination of Herbal Extracts to Prevent Symptoms Alcohol-induced Hangovers : A Randomized, Double Blind Placebo Controlled Crossover Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Armenia
    • Yerevan
      • Abovyan, Yerevan, Armenia, 0001
        • UNIMED Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LACIME Anti-hangover
Combination of plant extracts under liquid form. Oral administration. Dosage 100 ml. To drink 1h00 before alcohol intake together with meal.
Dietary supplement: LACIME Anti-hangover

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 Comparator: Placebo
Carrot juice under liquid form. Oral administration. Dosage 100 ml. To drink 1h00 before alcohol intake together with meal.
Other: Placebo

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the difference in Hangover Severity Scores between the activity of LACIME Anti-hangover and the activity of PLACEBO.
Time Frame: Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)

Evaluation of the difference in Hangover Severity Scores between the activity of LACIME Anti-hangover and the activity of PLACEBO.

The measure is the true change in self assessment scores from their baseline. 12 self assessed parameters :

  • Headache,
  • Fatigue, weakness
  • Thirsty
  • Dry mouth
  • Nausea
  • Vomiting
  • Trembling
  • Sweat
  • Depressed
  • Anxiety
  • Trouble Sleeping
  • Sensitivity to light

For each of the above symptoms, the Hangover Severity Scale ranges from 0 to 4.

The Scores are evaluated according to the following:

  • Absent=0
  • Mild=1
  • Moderate=2
  • Severe=3
  • Incapacitating=4

Self assessment is achieved:

  • Day 1 : 1h00 before alcohol intake (baseline)
  • Day 1 : Alcohol and meal intake
  • Day 1 : 1h00 after alcohol intake (Visit 1a)
  • Day 1 : 4h00 after alcohol intake (Visit 1b)
  • Day 1 : 15h00 after alcohol intake (Visit 1c)
Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)

The test "d2" consists of identifying and marking the letters "d" accompanied by two dashes only in the middle of other annoying characters.

The test "d2" is an array containing 14 lines of 47 characters which must all be checked.

The recorded figures are :

  • correctly identifyed characters,
  • omissions,
  • confusions,
  • total number of errors.

Three indices, reveal the evolution of the concentration:

  • Concentration Performance (error-corrected processing rate)
  • Speed of treatment
  • Fluctuation Rate (precision in treatment and accuracy)

Changes of psychometric parameters are evaluated by d2 test at:

  • Day 1 : 1h00 before alcohol intake (baseline)
  • Day 1 : Alcohol and meal intake
  • Day 1 : 1h00 after alcohol intake (Visit 1a)
  • Day 1 : 4h00 after alcohol intake (Visit 1b)
  • Day 1 : 15h00 after alcohol intake (Visit 1c)
Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)
Acetaldehyde blood assay (Jones, 2008)
Time Frame: Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)

Alcohol is mainly metabolized by hepatic oxydation by NADH / NAD+ enzymatic route.

Ingestion of Alcohol provoques an increase in the ratio NADH / NAD+ which disrupts all the other metabolic pathways in equilibrium with this coenzyme.

In the first stage of hepatic metabolism, the enzyme dehydrogenase converts alcohol into Acetaldehyde, a very toxic substance that has effects on the entire body.

Acetaldehyde is a choice marker to evaluate the level of alcoholic intoxication whenever it is an acute, massive or chronic absorption.

Titration of blood concentration of Acetaldehyde in mg/l

Changes of blood parameters from baseline are evaluated at:

  • Day 1 : 1h00 before alcohol intake (baseline)
  • Day 1 : Alcohol and meal intake
  • Day 1 : 1h00 after alcohol intake (Visit 1a)
  • Day 1 : 4h00 after alcohol intake (Visit 1b)
  • Day 1 : 15h00 after alcohol intake (Visit 1c)
Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incara Lab

Collaborators

Phytomed AB

Investigators

  • Study Chair: Alexander PANOSSIAN, Pr., Dr, Swedish Herbal Institute AB
  • Study Director: Areg HOVHANNISYAN, PhD, Dr.Sci, Head od National Anti-Doping Organization
  • Principal Investigator: Artur POTOSSIAN, Dr. MD, CARDIOMED Family Health Center
  • Principal Investigator: Samvel HAYRUMYAN, PhD, MD, CARDIOMED Family Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2019

Primary Completion (Actual)

August 26, 2019

Study Completion (Actual)

September 7, 2019

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

November 28, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Actual)

December 3, 2019

Last Update Submitted That Met QC Criteria

November 28, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM-2019-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 2 months after study completion for 6 months.

IPD Sharing Access Criteria

Data access is controlled by the Central Contact Person. Please contact bommelaer@shadeline.com for Password

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Study Data/Documents

  1. Protocol, Validation of Ethic Comitee, Informed consent form, D2 test of attention, Hangover severity scale, Randomization chart
    Information comments: Password will be provided by Administrator. Please ask for it at : bommelaer@shadeline.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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