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Healthy VolunteerGASTONNCT06728761

Gastric Emptying With Trou Normand

A study testing Standardised test meal, Ingestion of test drink and Ultrasound measurement of the antral area in people with Healthy Volunteer, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
Standardised test meal, Ingestion of test drink and Ultrasound measurement of the antral area
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteFrance
Study dates
19 Dec 2025to 11 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hopital Femme Mère enfant

    Bron, Rhone, 69500

Other trials in France

About this study

Official title: Evaluation of the Impact of Calvados ("Trou Normand") Consumption on Gastric Emptying After a High-calorie Meal

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.

Read more

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.

Being tested
Standardised test meal, Ingestion of test drink, Ingestion of Control drink, Ultrasound measurement of the antral area, Breathalyser for measurement of the level of exhaled ethanol
Keywords
gastric emptying, calvados

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standardised test mealBehavioural

    Ingestion of a 1850 Kcal standardised 'Christmas meal' identical for each session. It will consist of the following elements Assortment of Picard Mini-Puff Pastry Aperitifs: 70g = 210 Kcal 1 glass of white wine = 85 Kcal with the aperitif

    1 slice of vacuum-packed foie gras = 50 g = 230 Kcal

    1 portion of turkey leg 200 g = 250 Kcal 50 g turkey cream = 130 Kcal

    1 portion of steamed potatoes = 200 g = 160 Kcal

    1 glass of red wine = 85 Kcal to accompany the main course

    1 slice of white bread (30 g) = 55 Kcal to eat with the main course Blind test or control drink (trou normand or placebo = water) / 1 scoop of apple sorbet

    1 portion 30 g camembert = 90 Kcal + White bread 1 slice (30 g) = 85 Kcal with the cheese

    1 portion crumble 100 g = 250 Kcal The different elements will be weighed for each participant.

  • Ingestion of test drinkBehavioural

    Ingestion of 2,5 cl Calvados 40° at the 70th min of the meal (before cheese and dessert)

  • Ingestion of Control drinkBehavioural

    Ingestion of 2,5 cl water at the 70th min of the meal (before cheese and dessert)

  • Ultrasound measurement of the antral areaDiagnostic test

    Ultrasound measurement of the antral area in the volunteers lying in the 45° semi-recumbent position using an ultrasound machine (Venue Go™, GE Healthcare, Chicago, IL, USA) fitted with an abdominal transducer (probe C1-5, 1.5 to 5 MHz) to obtain a sagittal cross-section of the antrum in a plane including the left lobe of the liver and the aorta. This will be performed during the intake visit, immediately before the test drink ingestion (70th min of the meal) and 15, 45, 60, 90, 120, 150, 180 min after the end of the meal

  • Breathalyser for measurement of the level of exhaled ethanolDiagnostic test

    Breathalyser performed 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.

  • DiscomfortBehavioural

    discomfort will be assessed using seven-choice Likert scales immediately before the test drink ingestion and 90 min and 180 min after the end of the standardized meal.

  • AppetiteBehavioural

    Appetite will be assessed using seven-choice Likert scales immediately before the test drink ingestion and 90 min and 180 min after the end of the standardized meal.

  • Pregnancy urine test carried out during the intake visit on the day of the protocolDiagnostic test

    Pregnancy urine test carried out during the intake visit on the day of the protocol for exclusion of pregnant woman.

Study groups in NCT06728761
Study groupRoleWhat they receive
CalvadosExperimentalIngestion of test drink: Calvados. The volunteer will be invited to drink 2.5 cl of Calvados 40° at the 70th minute of the meal, before the cheese and dessert
Receives: Behavioral: Standardised test meal; Behavioral: Ingestion of test drink; Diagnostic Test: Ultrasound measurement of the antral area; Diagnostic Test: Breathalyser for measurement of the level of exhaled ethanol; Behavioral: Discomfort; Behavioral: Appetite; Diagnostic Test: Pregnancy urine test carried out during the intake visit on the day of the protocol
WaterActive comparatorIngestion of Control drink: Water. The volunteer will be invited to drink 2.5 cl of water at the 70th minute of the meal, before the cheese and dessert
Receives: Behavioral: Standardised test meal; Behavioral: Ingestion of Control drink; Diagnostic Test: Ultrasound measurement of the antral area; Diagnostic Test: Breathalyser for measurement of the level of exhaled ethanol; Behavioral: Discomfort; Behavioral: Appetite; Diagnostic Test: Pregnancy urine test carried out during the intake visit on the day of the protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. gastric emptying half-time of a standardised meal during the two sessions (calvados or water).

    determination of the half-time of gastric emptying of a standardised meal (1850 Kcal) based on repeated measurements of the antral surface after the end of the standardised meal in both sessions.

    Measured: 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 (3)
  1. gastric emptying rate during the two sessions

    gastric emptying rate based on ultrasound measurements of the antral area taken at 15 minutes and 90 minutes after the end of the standardized meal

    Measured: 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

  2. discomfort and appetite

    discomfort and appetite will be assessed using seven-choice Likert scales immediately before the test drink ingestion and 90 min and 180 min after the end of the standardized meal Kikert scales 1 to 7. 7 is strong desire for food, high appetite

    Measured: 90 min and 180 min after the end of the standardized meal

  3. level of exhaled ethanol

    Breathalyser for measurement of the level of exhaled ethanol

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2024
  2. Study start19 Dec 2025
  3. Primary completion11 Mar 2026
  4. Study completion11 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06728761
Sponsor's protocol ID
69HCL24_0480
Acronym
GASTON
Status last verified
Jan 2026
First submitted
6 Dec 2024
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Standardised test meal, Ingestion of test drink and Ultrasound measurement of the antral area in people with Healthy Volunteer, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

gastric emptying half-time of a standardised meal during the two sessions (calvados or water). (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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