Healthy ParticipantsPhase 4NCT00943696
Effects of White Wine vs. Tea Intake During and an Alcoholic Digestive Following a High Fat, High Calorie Cheese Fondue Meal on Gastric Emptying and Abdominal Symptoms in Healthy Volunteers
A Phase 4 study testing Ingestion of white wine vs. tea during and an alco in people with Healthy Participants, run by University of Zurich at 1 site in Switzerland.
Trial summary
Tradition holds that the intake of different drinks with a meal has an important influence on the digestion of food and postprandial symptoms such as fullness, bloating and satiety; however this assumption have never been subjected to controlled study A classic example is the Swiss cheese fondue. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Ingestion of white wine vs. tea during and an alco
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2009to Oct 2009
- Phase
- Phase 4
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Inclusion criteria: • able to communicate well with the investigators and provide written consent
- Body Mass Index: 19-30 kg/m2
Exclusion criteria: • physical co-morbidity requiring active treatment
- psychiatric (DSM IV) disorders limiting the ability to comply with study
- use of medications influencing upper GI motility
- evidence of current drug or alcohol abuse
- history of gastrointestinal disease or surgery except appendicectomy or hernia repair
Trial locations and contacts
1 site in 1 country.
About this study
Tradition holds that the intake of different drinks with a meal has an important influence on the digestion of food and postprandial symptoms such as fullness, bloating and satiety; however this assumption have never been subjected to controlled study
A classic example is the Swiss cheese fondue. The intake of white wine, tea and cherry schnapps (Kirsch) are often attributed either positive or negative effects on the gastrointestinal tract.
Read more
In this study the effect of white wine vs. tea intake during and an alcoholic digestive following a high fat, high calorie Swiss fondue meal on gastric emptying and visceral perception will be investigated using a randomized, controlled study design.
The fondue will be labeled with non-radioactive 13C octanoate for assessment of gastric emptying by breath-test.
- Conditions
- Healthy Participants
- Being tested
- Ingestion of white wine vs. tea during and an alco
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingestion of white wine vs. tea during and an alcoDietary supplement
4 x 50ml glasses of white wine (12% alcohol) or tea will be taken according to a randomization scheme After the meal 1 x 20ml of Kirsch (40% alcohol) or tea will be taken
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of white wine vs. tea on gastric emptying
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- COOP
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943696
- Sponsor's protocol ID
- Fonduestudie_EKGs
- Status last verified
- Jun 2010
- First submitted
- 20 Jul 2009
- Last updated
- 28 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Heinrich H, Goetze O, Menne D, Iten PX, Fruehauf H, Vavricka SR, Schwizer W, Fried M, Fox M. Effect on gastric function and symptoms of drinking wine, black tea, or schnapps with a Swiss cheese fondue: randomised controlled crossover trial. BMJ. 2010 Dec 14;341:c6731. doi: 10.1136/bmj.c6731.
PubMed 21156747
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of White Wine vs. Tea Intake During and an Alcoholic Digestive Following a High Fat, High Calorie Cheese Fondue Meal on Gastric Emptying and Abdominal Symptoms in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00943696
- Acronym / sponsor ID
- Fonduestudie_EKGs
- Conditions
- Healthy Participants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- COOP
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tradition holds that the intake of different drinks with a meal has an important influence on the digestion of food and postprandial symptoms such as fullness, bloating and satiety; however this assumption have never been subjected to controlled study
A classic example is the Swiss cheese fondue. The intake of white wine, tea and cherry schnapps (Kirsch) are often attributed either positive or negative effects on the gastrointestinal tract.
In this study the effect of white wine vs. tea intake during and an alcoholic digestive following a high fat, high calorie Swiss fondue meal on gastric emptying and visceral perception will be investigated using a randomized, controlled study design.
The fondue will be labeled with non-radioactive 13C octanoate for assessment of gastric emptying by breath-test.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ingestion of white wine vs. tea during and an alco4 x 50ml glasses of white wine (12% alcohol) or tea will be taken according to a randomization scheme After the meal 1 x 20ml of Kirsch (40% alcohol) or tea will be taken | Dietary supplement | – |
Primary outcome
Effect of white wine vs. tea on gastric emptying
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2010.
- Derived from this study: PubMed 21156747Heinrich H, Goetze O, Menne D, Iten PX, Fruehauf H, Vavricka SR, Schwizer W, Fried M, Fox M. Effect on gastric function and symptoms of drinking wine, black tea, or schnapps with a Swiss cheese fondue: randomised controlled crossover trial. BMJ. 2010 Dec 14;341:c6731. doi: 10.1136/bmj.c6731.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ingestion of white wine vs. tea during and an alco in people with Healthy Participants, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Jun 2010. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect of white wine vs. tea on gastric emptying (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00943696, which also lists 1 linked publication.
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 28 Jun 2010.