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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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27 February 2017 |
Main ID: |
ISRCTN11688283 |
Date of registration:
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01/02/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Cardiovascular and cutaneous responses to the combination of alcohol and soft drinks: the way to orthostatic intolerance?
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Scientific title:
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Acute ingestion of sugar and alcohol in healthy young people: the way to orthostatic hypotension? |
Date of first enrolment:
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01/02/2016 |
Target sample size:
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24 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN11688283 |
Study type:
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Interventional |
Study design:
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Randomised cross over study (Prevention)
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Phase:
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Claire
Maufrais |
Address:
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University of Fribourg
Chemin du musee 5
1700
Fribourg
Switzerland |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged 18-30 years 2. Non-smokers 3. No disease or medication affecting cardiovascular or autonomic regulation
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute alcohol ingestion in young people Nutritional, Metabolic, Endocrine Acute alcohol ingestion in young people
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Intervention(s)
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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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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University of Fribourg
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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