Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/01/2017
Date assigned
01/02/2017
Last edited
14/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measure

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 (if study stopped)

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

Sponsor information

Organisation

University of Fribourg

Sponsor details

Chemin du musee 5
Fribourg
1700
Switzerland

Sponsor type

University/education

Website

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

Basic results (scientific)

See additional file ISRCTN11688283_BasicResults_31Jan16

Publication list

Publication citations

Additional files

Editorial Notes

14/02/2017: Results summary uploaded.