Plain English Summary
Background and study aims
Drinking alcohol is common among young people during festive events. Many studies have shown that drinking moderate amounts of alcohol leads to an increase in heart rate and the widening of blood vessels (vasodilation), as well as other issues with blood circulation. When standing upright, gravity means that blood falls towards the feet, and so the body must respond by increasing blood pressure to keep blood flowing to the brain. There is evidence to suggest that drinking alcohol can also interfere with this function (orthostatic hypotension). At festive events, alcohol is usually served with fruit juice or other kinds of sugary drinks. Although the effects of consuming alcohol have been well studied in healthy individuals, there is little research looking at the interaction of sugary drinks with alcohol on the regulation of circulation. The aim of this study is to look at the effects of drinking alcohol when combined with sugary drinks on the circulatory system (heart and blood vessels).
Who can participate?
Healthy adults aged between 18 and 30 who do not smoke.
What does the study involve?
Participants attend four study sessions spaced two days apart in a random order. All sessions take place between 08:00 and 09:00 in the laboratory after 12 hours of not having eaten. Before each session (at around 07:00), participants eat a light breakfast provided by the research team which consists of light ice tea and two cereal bars. They then complete a standing test before drinking either water missed with lemon juice (condition 1), sugar and lemon juice mixed with water (condition 2), 40% vodka missed with lemon juice and water (condition 3) or 40% vodka mixed with sugar, water and lemon juice (condition 4). Participants have their blood pressure monitored continuously for 120 minutes after drinking each drink.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.
Where is the study run from?
University of Fribourg (Switzerland)
When is the study starting and how long is it expected to run for?
March 2015 to October 2016
Who is funding the study?
University of Fribourg (Switzerland)
Who is the main contact?
Dr Claire Maufrias
Trial website
Contact information
Type
Scientific
Primary contact
Dr Claire Maufrais
ORCID ID
http://orcid.org/0000-0001-6530-3393
Contact details
University of Fribourg
Chemin du musee 5
Fribourg
1700
Switzerland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Alcopops
Study information
Scientific title
Acute ingestion of sugar and alcohol in healthy young people: the way to orthostatic hypotension?
Acronym
Study hypothesis
The vasodilatory properties of alcohol and the alcohol-induced dysregulation of autonomic tone are potentiated by the concomitant ingestion of sugary drinks in young people (simulating alcopops ingestion), and thus that the combination of sugars with alcohol will accentuate the systemic vasodilation and increase orthostatic intolerance.
Ethics approval
Commission cantonale d’éthique de la recherche sur l’être humain (CER-VD), 28/04/2015, ref: 105/15
Study design
Randomised cross over study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute alcohol ingestion in young people
Intervention
All participants attend four separate experimental sessions (each session separated at least by 2 days) according to a randomized crossover study. Randomization is performed using a random sequence generator (http://www.random.org/sequences/) where the session order is determined for 24 test subjects before the study starts.
All experiments take place in a quiet, temperature-controlled (20–22 °C) laboratory and started between 08.00 and 09.00 A.M. On the day of the experiment, after an overnight (12-h) fast, participants eat a light standardized breakfast provided provided by the research team at around 07:00, consisting of one mini-pack of 33 cl of commercial light ice tea (33 kcal, 8 g carbohydrates/6.6 g sugar) and two cereal bars (total of 150 kcal, 39 g carbohydrates/12 g sugar), to ensure that consumption of alcohol in the same morning is done on an empty stomach.
Following a variable period for reaching cardiovascular and metabolic stability (usually between 10-15 minutes), and after a stable baseline recording of at least 30 minutes, participants undergo an orthostatic test consisting of active standing from the sitting position, maintained during 10 min, and then returning to a sitting position. Participants then ingest one of the following four drinks at a temperature of around 10°C (at a convenient pace over 5 min):
1. 390 mL distilled water + 10 mL lemon juice
2. 48 g sucrose + 10 mL lemon juice, diluted in distilled water up to a total volume of 400 mL
3. 40% vodka (40% alcohol per volume, given at 1.28 mL.kg-1 of body weight, providing 0.5 g alcohol/kg) + 10 mL lemon juice, diluted in distilled water up to 400 mL
4. 48 g sucrose + 40% vodka (at 1.28 mL.kg-1) + 10 mL lemon juice, diluted in distilled water up to 400 mL.
Hemodynamic monitoring continues for another 130 minutes post-drink ingestion with a 10 min orthostatic test at 60 and 120 min post-drink ingestion.
Intervention type
Phase
Drug names
Primary outcome measures
Blood pressure is measured using a task force monitor at baseline and averaged over these different timepoints post-ingestion: 0-10min, 10-20min, 20-40min, 40-60min and 100-120min
Secondary outcome measures
Vasodilation was calculated using task force monitor (i.e. total peripheral resistance) and estimated using thermographic pictures (hand temperature) at baseline and averaged over these different timepoints post-ingestion: 0-10min, 10-20min, 20-40min, 40-60min and 100-120min.
Overall trial start date
01/03/2015
Overall trial end date
01/10/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18-30 years
2. Non-smokers
3. No disease or medication affecting cardiovascular or autonomic regulation
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
24
Participant exclusion criteria
1. BMI greater than 30 kg.m-2
2. Competition athletes
3. Individuals with a daily exercise workload exceeding 60 min per day
Recruitment start date
01/02/2016
Recruitment end date
15/09/2016
Locations
Countries of recruitment
Switzerland
Trial participating centre
University of Fribourg
Department of Medicine/Physiology
Chemin du musee 5
Fribourg
1700
Switzerland
Funders
Funder type
University/education
Funder name
University of Fribourg
Alternative name(s)
Universität Freiburg, University of Fribourg
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Switzerland
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal before September 2017.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Claire Maufrais (claire.maufrais@hotmail.com)
Intention to publish date
01/09/2017
Participant level data
Available on request
Results - basic reporting
See additional file ISRCTN11688283_BasicResults_31Jan16
Publication summary
Publication citations
Additional files
- ISRCTN11688283_BasicResults_31Jan16.docx Uploaded 14/02/2017