Clinical trial NCT06728761: Gastric Emptying With Trou Normand
Official title: Evaluation of the Impact of Calvados ("Trou Normand") Consumption on Gastric Emptying After a High-calorie Meal
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Volunteer
Keywords: gastric emptying
calvados
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In France, alcohol is responsible for 30% of road deaths. The risk of being responsible for a fatal accident is multiplied by 17.8 for drink-drivers, and accidents involving alcohol consumption are more serious than others: the number of people killed per 100 injured in hospital is 23 for accidents involving alcohol, compared with 10 for accidents without alcohol. Alcohol is therefore responsible for an increased risk of road accidents, resulting in a high rate of alcohol-impaired victims being treated in emergency departments and operating theatres. Their management is all the more difficult in the operating theatre because these victims have a high gastric content, increasing the risk of pulmonary inhalation of gastric contents during the general anaesthesia required to treat trauma. Inhalation is one of the main causes of anaesthesia-related mortality.

ccident rates are higher during the festive season. Drinking high-alcohol beverages is reputed to help the digestion of rich meals and therefore improve digestive tolerance (abdominal symptoms: heaviness, bloating) and appetite during festive meals. The 'trou normand' consists of drinking calvados (alcohol: 40°) + 1 scoop of sorbet during the meal to improve digestion. The 'trou normand' is very popular on social networks and on restaurant menus, particularly during festive occasions such as weddings and Christmas meals. This belief may encourage the consumption of strong alcohol during festive meals, which is added to the usual alcohol consumption during this type of meal (wine), significantly increasing blood alcohol levels since 2.5 cl of an alcoholic beverage at 40° will have the same effect as 10 cl of wine at 10-12°. However, the alleged benefit of alcohol consumption on gastric emptying has never been demonstrated. On the contrary, some data in the literature suggest that alcohol consumption is associated with a slowing of gastric emptying.

The aim of this study is therefore to evaluate specifically the effect of strong alcohol consumption on gastric emptying of the liquid and solid components of a festive meal, as well as the effect on abdominal symptoms and appetite.

After verification of eligibility criteria and gastric content by an initial ultrasound examination and an alcohol test, the volunteers will be asked to consume a standardised meal of 1850 Kcal accompanied by a 12 cl glass of white wine (12°) at the start of the meal, a 12 cl glass of red wine with the main course (12°) and 2 glasses of water (20 cl) over 90 minutes. According to the randomisation, the volunteer will be invited, before the cheese and dessert, at the 70th minute, to drink 2.5 cl of water + 1 scoop of sorbet or 2.5 cl of Calvados 40° + 1 scoop of sorbet before the cheese and dessert, which will then be consumed within 20 minutes.

Immediately before ingesting the test drink, an ultrasound examination of the antrum will be carried out to measure the antral cross-sectional area. An antral ultrasound will be carried out 15, 45, 60, 90, 120, 150 and 180 minutes after the end of the meal, blind to the drink ingested, and a breathalyser test will be carried out at times 15, 90, 180 min and possibly 300 min after the end of the meal if the exhaled alcohol level measured at 180 min was greater than 0.25 mg/l of exhaled air. Volunteers will also be asked to indicate their abdominal discomfort and appetite on a seven-choice Likert scale before starting to eat the meal, then at the end of the standardised meal, then 1 h 30 and 3 h after the end of the meal.


Eligibility criteria: Inclusion Criteria:

* adult volunteers ≥ 18 years and \< 65 years of age
* with no significant medical history (American Society of Anesthesiologists class ASA 1)
* fasted for at least 6 hours for alcohol and solids
* signed informed consent
* affiliated to the social security system.

Exclusion Criteria:

* adults of full age under legal protection (guardianship, curatorship)
* young drivers holding a probationary licence
* persons deprived of their liberty by a judicial or administrative decision
* persons under psychiatric care
* a history of oeso-gastro-duodenal surgery
* current pregnancy or breast-feeding
* any pathology that may affect gastric volume: insulin-dependent diabetes or diabetes mellitus, gastro-oesophageal reflux, hypothyroidism or hyperthyroidism
* treatments affecting gastric motility (erythromycin, metoclopramide, etc.)
* any treatment incompatible with alcohol consumption
* any pathology incompatible with alcohol consumption (liver or neurological pathologies in particular)
* obesity defined by a body mass index ≥ 30 kg/m².
* Alcohol dependence (AUDIT questionnaire): Alcohol Use Disorders Identification Test) is a simple 10-question test.
* Volunteers with a direct hierarchical link to the investigators

Primary outcomes:
measure: gastric emptying half-time of a standardised meal during the two sessions (calvados or water).
timeFrame: half-time of gastric emptying of the standardised will be calculated based on the measurement of the antral area performed 15, 45, 60, 90, 120, 150 and 180 minutes after the end of the standardised meal (1850 Kcal), blindly to the drink ingested
Secondary outcomes:
measure: gastric emptying rate during the two sessions
timeFrame: Calculation will be made based on ultrasound measurements of the antral area at 15 minutes and 90 minutes minutes after the end of the standardized meal
measure: discomfort and appetite
timeFrame: 90 min and 180 min after the end of the standardized meal
measure: level of exhaled ethanol
timeFrame: Breathalyser during the intake visit, and 15, 90, 180 and 300 min (if the exhaled alcohol level measured at 180 minutes was greater than 0.25 mg/l of breath) after the end of the meal.
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Femme Mère enfant
state: Rhone
Study officials:
References: