None listed
Conditions
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).
Interventions
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 cons
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.
Sponsors
BioRevive Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Regularly experience a hangover and in good health.
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.
Outcome results
None listed