Gastrointestinal and Digestive Disorder
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTDark chocolate bar
Dark chocolate bar (70% cocoa solids (\ 500kcal, \ 50% fat)), 100g / day for 3 days to assess postprandial brain activity and colonic transit by FDG-PET.
DIETARY_SUPPLEMENTDark chocolate mousse
Dark chocolate mousse (150g, \ 500kcal, \ 50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.
DIETARY_SUPPLEMENTWhite chocolate bar
White chocolate bar (0% cocoa solids (\ 500kcal, 50% fat)), 100g / day for 3 days to assess postprandial brain activity and colonic transit by FDG-PET.
DIETARY_SUPPLEMENTWhite chocolate mousse
White chocolate mousse (150g, \ 500kcal, \ 50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers (men and women) * aged 18-65 years * body mass index 18-30kg/m2.
Exclusion criteria
* special dietary requirements incompatible with dietary intervention (food allergies or intolerances) * clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) that preclude intake of test meals * participation in another study with investigational drug within the 30 days preceding and during the present study (purely diagnostic studies are acceptable) * individuals unwilling to provide written informed consent * inability to follow the procedures of the study, e.g. due to language problems (all study documents in English)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric emptying half time | Baseline until 2 hours postingestion | assessed by scintigraphy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oro-caecal transit time (OCTT) | Baseline until 3 hours postingestion | assessed by scintigraphy and 13-C Lactose-Ureide |
| Colonic transit time | Baseline until 3 days after ingestion | assessed by radio-opaque marker technique |
| Post-prandial satiety | changes from baseline to three hours after treatment | assessed by visual analogue scales |
| Gastrointestinal well-being | changes from baseline to three hours after treatment | assessed by Likert scale |
Countries
Switzerland
Outcome results
None listed