Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000818831
Ethics application status
Approved
Date submitted
30/03/2020
Date registered
28/06/2021
Date last updated
28/06/2021
Date data sharing statement initially provided
28/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of a vitamin and amino acid supplement on hangover symptom severity
Scientific title
The effects of a vitamin and amino acid supplement on hangover symptom severity
Secondary ID [1] 300776 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hangover 316625 0
Condition category
Condition code
Metabolic and Endocrine 314860 314860 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions will be consumed on two separate occasions; 1) one session where the active treatment will be administered and 2) one session where the placebo will be administered (counterbalanced). Alcohol intake (i.e. drink type, time of drink, etc) will be recorded during the first testing visit and replicated in the second visit.

Alcohol: consumed freely up to a maximum of 1.3g/kg. There is no minimum amount of alcohol to be consumed. Participants will choose the drink type(s) they consume (e.g. beer, red wine, etc) and all alcohol will be provided by the researchers.

VitAmo: Two capsules administered orally with the first drink of alcohol. Participants will be supervised under laboratory conditions while taking the capsules to ensure adherence.

Each capsule contains Vitamin B3 50mg; Isoleucine 49mg; Leucine 35mg; Valine 35mg; Thiamine hydrochloride, equiv. to 25mg Vitamin B1; Ascorbic acid (Vitamin C) 22.5mg; Alanine 21mg; Glycine 12mg; Calcium pantothenate, equiv. to 6mg Vitamin B5; d-alpha Tocopheryl acetate, equiv. to 2.5 mg Vitamin E; Iron phosphate 6.08mg equiv. to 2.25mg Iron; Riboflavin (Vitamin B2) 1.3mg; Beta carotene 225 µg; Biotin 15µg; Cyanocobalamin, equiv. to 10µg Vitamin B12; Ergocalciferol, equiv. to 100IU Vitamin D2.

A subset of participants (20 participants) can self-select to participate in the brain imaging (fMRI) component of this study. This will entail undergoing 3 scans throughout the testing period.
Intervention code [1] 317100 0
Prevention
Comparator / control treatment
Placebo: Silica, Magnesiumphosphate, Microcrystalline cellulose, Dicalcium phosphate, Calcium Hydrogen phosphate dihydrate, and an insoluble colour pigment (Iron oxide).

The placebo is in oral capsule form and is visually identical to the active treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 323202 0
Presence and severity of self- reported hangover:

Overall hangover severity will be measured using a single one-item scale ranging from 0 to 10.
Timepoint [1] 323202 0
The mornings following alcohol consumption. This will be within 12-hours of the final drink consumed.
Primary outcome [2] 323206 0
Cognitive performance:
Measured using the Schuhfried Vienna Test System, specifically, the RT Reaction Time, DT Determination Test and ATAVT Adaptive Tachistoscopic Traffic Perception Tests.
Timepoint [2] 323206 0
The mornings following alcohol consumption. This will be within 12-hours of the final drink consumed.
Primary outcome [3] 323207 0
Liver function assessed by serum assay.
Timepoint [3] 323207 0
Baseline and the mornings following alcohol consumption, which will be within 12-hours of the final drink consumed.
Secondary outcome [1] 381180 0
fMRI:
BOLD response during a cognitive task (subset of participants only)
Timepoint [1] 381180 0
Baseline and the mornings following alcohol consumption (within 12-hours of the final drink consumed).
Secondary outcome [2] 381181 0
Groningen Sleep Quality Scale (GSQS)
Timepoint [2] 381181 0
The mornings following alcohol consumption (within 12-hours of the final drink consumed).
Secondary outcome [3] 381182 0
Breath ethanol levels.
Timepoint [3] 381182 0
During alcohol consumption (every hour for 4 hours of alcohol consumption).
Secondary outcome [4] 392802 0
Alcohol hangover severity:

23 item hangover scales measuring symptoms and their severity on a Likert scale from 0 to 10.
Timepoint [4] 392802 0
The mornings following alcohol consumption. This will be within 12-hours of the final drink consumed.
Secondary outcome [5] 392803 0
Biomarker:

Cytokine levels including TNF-a, IL-1b, IL-2, IL-4, IL-6, IL-10 and IFN-y assessed by serum assay..
Timepoint [5] 392803 0
Baseline and the mornings following alcohol consumption, which will be within 12-hours of the final drink consumed.
Secondary outcome [6] 392804 0
Biomarker:

Cortisol levels assessed by saliva.
Timepoint [6] 392804 0
Baseline and the mornings following alcohol consumption, which will be within 12-hours of the final drink consumed.
Secondary outcome [7] 392805 0
fMRI:

Cerebral blood flow (ASL) (subset of participants only)
Timepoint [7] 392805 0
Baseline and the mornings following alcohol consumption (within 12-hours of the final drink consumed).
Secondary outcome [8] 392806 0
fMRI:

GABA concentrations (subset of participants only).
Timepoint [8] 392806 0
Baseline and the mornings following alcohol consumption (within 12-hours of the final drink consumed).
Secondary outcome [9] 392807 0
Current sleepiness:

Karolinska Sleepiness Scale (KSS).
Timepoint [9] 392807 0
The mornings following alcohol consumption. This will be within 12-hours of the final drink consumed.
Secondary outcome [10] 392808 0
Alcohol metabolism:

Measured according to urine ethanol levels.
Timepoint [10] 392808 0
During alcohol consumption (every hour the 4 hours of alcohol consumption).
Secondary outcome [11] 392809 0
Alcohol metabolism:

Measured according to transdermal ethanol levels.
Timepoint [11] 392809 0
During alcohol consumption (every hour the 4 hours of alcohol consumption).

Eligibility
Key inclusion criteria
Regularly experience a hangover and in good health.
Minimum age
25 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current or history of alcohol/drug abuse, current medically treated liver or renal impairment, if female; pregnant or breast-feeding, use of any medication that may interact with alcohol, in the fMRI component; left-handedness, metal implants and claustrophobia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/03/2020
Date of last participant enrolment
Anticipated
13/09/2021
Actual
Date of last data collection
Anticipated
1/10/2021
Actual
Sample size
Target
44
Accrual to date
32
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305235 0
Commercial sector/Industry
Name [1] 305235 0
BioRevive Pty Ltd
Country [1] 305235 0
Australia
Funding source category [2] 305239 0
Government body
Name [2] 305239 0
Commonwealth Innovation Connections Grant; Department of Industry, Innovation and Science
Country [2] 305239 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BioRevive Pty Ltd
Address
182-184 Stawell Street, Burnley, VIC 3121
Country
Australia
Secondary sponsor category [1] 305595 0
None
Name [1] 305595 0
Address [1] 305595 0
Country [1] 305595 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305579 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 305579 0
Research Ethics, Integrity and Biosafety Office
Swinburne Research (H68)
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 305579 0
Australia
Date submitted for ethics approval [1] 305579 0
Approval date [1] 305579 0
17/09/2019
Ethics approval number [1] 305579 0

Summary
Brief summary
The aim of this study is to determine whether a natural product can improve hangover symptoms and several physiological changes that occur with hangover (i.e. liver function, inflammatory stress and stress hormone levels). A total of 44 participants aged 25-55 years old will complete this trial. The supplement contains a mix of vitamins and amino acid, which have been shown to improve the breakdown of alcohol-related toxins and/or improve hangover symptom severity. The combination of these ingredients has not been previously assessed in relation to hangover.
Many biological changes occur with a hangover and contribute to hangover symptoms. We are particularly interested in the effects of hangover on liver function, inflammatory stress measured by cytokine levels, and stress according to cortisol levels. We will be measuring the effects of the supplement, compared to a placebo, using self-report assessments of hangover severity, anxiety, sleep quality and fatigue, cognitive functioning (e.g. response times, concentration, etc.) and physiological changes following an evening of alcohol intake to a quantity that would typically be consumed resulting in a hangover. We will also measure alcohol metabolism by asking participants to wear a wristband to measure alcohol in sweat, along with asking participants to undergo breathalyser and blood and urine tests for alcohol levels.. A subset of participants will be invited to participate in a brain imaging component using Magnetic Resonance Imaging (MRI).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100842 0
Dr Sarah Benson
Address 100842 0
Swinburne University, PO Box 218, Hawthorn, Victoria, 3122
Country 100842 0
Australia
Phone 100842 0
+61 3 9214 5212
Fax 100842 0
Email 100842 0
[email protected]
Contact person for public queries
Name 100843 0
Dr Sarah Benson
Address 100843 0
Swinburne University, PO Box 218, Hawthorn, Victoria, 3122
Country 100843 0
Australia
Phone 100843 0
+61 3 9214 5212
Fax 100843 0
Email 100843 0
[email protected]
Contact person for scientific queries
Name 100844 0
Dr Sarah Benson
Address 100844 0
Swinburne University, PO Box 218, Hawthorn, Victoria, 3122
Country 100844 0
Australia
Phone 100844 0
+61 3 9214 5212
Fax 100844 0
Email 100844 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is expected that the results of this trial will be disseminated via peer-reviewed publications and at academic conferences. For these purposes the data will be collated and analysed as group data. If required by the publishing journal, de-identified raw data will be uploaded to an appropriate repository.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.