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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00943696
Other study ID # Fonduestudie_EKGs
Secondary ID
Status Completed
Phase Phase 4
First received July 20, 2009
Last updated June 24, 2010
Start date August 2009
Est. completion date October 2009

Study information

Verified date June 2010
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: UZurich
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Zurich COOP

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of white wine vs. tea on gastric emptying 4 hours No
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