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
1 other identifier
interventional
12
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2009
CompletedFirst Posted
Study publicly available on registry
July 22, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedJune 28, 2010
June 1, 2010
2 months
July 20, 2009
June 24, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Effect of white wine vs. tea on gastric emptying
4 hours
Interventions
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
Eligibility Criteria
You may qualify if:
- Body Mass Index: 19-30 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zurichlead
- COOPcollaborator
Study Sites (1)
Unknown Facility
Zurich, Switzerland
Related Publications (1)
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.
PMID: 21156747DERIVED
Study Officials
- STUDY DIRECTOR
01 Studienregister MasterAdmins
UniversitaetsSpital Zuerich
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 20, 2009
First Posted
July 22, 2009
Study Start
August 1, 2009
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
June 28, 2010
Record last verified: 2010-06