NCT00943696

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2009

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

June 28, 2010

Status Verified

June 1, 2010

Enrollment Period

2 months

First QC Date

July 20, 2009

Last Update Submit

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

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Unknown Facility

Zurich, Switzerland

Location

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.

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

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

Locations