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

This study has been completed.
Sponsor:
Collaborator:
COOP
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00943696
First received: July 20, 2009
Last updated: June 24, 2010
Last verified: June 2010

July 20, 2009
June 24, 2010
August 2009
October 2009   (final data collection date for primary outcome measure)
Effect of white wine vs. tea on gastric emptying [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Effect of white wine vs. tea on gastric emptying
Complete list of historical versions of study NCT00943696 on ClinicalTrials.gov Archive Site
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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
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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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Healthy Participants
Dietary Supplement: Ingestion of white wine vs. tea during and an alco
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
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
19 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00943696
Fonduestudie_EKGs
No
Dr. Mark Fox, University of Zurich
University of Zurich
COOP
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
University of Zurich
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP