This trial is completed!
Search for a recruiting clinical trial for your condition
Your journey
1What's a trial
2Find
3Review
4Get in touch
More info
You can access this
clinical trial
if you have
Gastrointestinal and Digestive Disorder
and you are
between 18 and 65
years old
-
The phase for this study is not defined.
Show me locations

The purpose

This is a randomized, controlled, 2x2 cross-over study to assess the effects of cocoa solids on gastrointestinal transit, post-prandial sensation and well-being. Additionally functional brain imaging will be applied to identify regions of brain that are activated or inactivated by cocoa ingestion. Healthy subjects will be recruited and randomized to receive either dark chocolate (70% cocoa solids) or white chocolate (0% cocoa solids) in addition to their normal diet in randomized order. Reference standard methodology will be applied to measure gastric emptying, oro-caecal and colonic transit time. Dark and white chocolate (100g, ~500kcal, ~50% fat) will be consumed with radio-opaque markers on three consecutive days. On the third day chocolate ingestion will be followed by measurements of postprandial brain activity using FDG-Positron Emission Tomography. Additionally colonic transit will be assessed based on the number and distribution of radio-opaque markers in the colon. On the fourth day gastric emptying and oro-caecal transit time will be assessed by scintigraphy after ingestion of a dark or white chocolate mousse test meal (both 150g, ~500kcal, ~50% fat). During both interventional studies pre- and post-prandial satiety and dyspeptic symptoms, well-being and mood will be recorded. Additionally, validated questionnaires will assess digestive comfort and well-bring at the end of each study day. These results will deliver comprehensive information about the effects of cocoa on gastrointestinal transit and sensation.

Provided treatments

  • : Dark chocolate bar
  • : Dark chocolate mousse
  • : White chocolate bar
  • : White chocolate mousse

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT03022955. The sponsor of the trial is University Hospital, Basel, Switzerland and it is looking for 16 volunteers for the current phase.
Official trial title:
Effects of Cocoa Solids on Gastrointestinal Transit, Postprandial Sensation and Gastrointestinal Well-being: a Randomized, Controlled Trial in Healthy Volunteers