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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dark chocolate: FDG-PET | Active Comparator | 100 g dark chocolate bar (70% cocoa solids (~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 and colonic transit using chocolate: fluorodeoxyglucose Positron Emission Tomography (FDG-PET) |
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| Dark chocolate: Physiological Measurement | Active Comparator | 150 g dark chocolate mousse (~500kcal, ~50% fat) labelled with 13C-lactose-ureide and technetium (99Tc) will be consumed to assess gastric emptying and oro-caecal transit time by scintigraphy. |
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| White chocolate: FDG-PET | Placebo Comparator | 100 g white chocolate bar (0% cocoa solids (~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 and colonic transit using FDG-Positron Emission Tomography. |
|
| White chocolate: Physiological Measurement | Placebo Comparator | 150 g white chocolate mousse (~500kcal, ~50% fat) labelled with 13C-lactose-ureide and technetium (99Tc) will be consumed to assess gastric emptying and oro-caecal transit time by scintigraphy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dark chocolate bar | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying half time | assessed by scintigraphy | Baseline until 2 hours postingestion |
| Measure | Description | Time Frame |
|---|---|---|
| Oro-caecal transit time (OCTT) | assessed by scintigraphy and 13-C Lactose-Ureide | Baseline until 3 hours postingestion |
| Colonic transit time | assessed by radio-opaque marker technique |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Fox, Prof. Dr. | St. Claraspital Basel, Abdominal Center: Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Claraspital | Basel | 4016 | Switzerland |
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| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| Dark chocolate mousse | Dietary Supplement | Dark chocolate mousse (150g, ~500kcal, ~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy. |
|
| White chocolate bar | Dietary Supplement | 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. |
|
| White chocolate mousse | Dietary Supplement | White chocolate mousse (150g, ~500kcal, ~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy. |
|
| Baseline until 3 days after ingestion |
| Post-prandial satiety | assessed by visual analogue scales | changes from baseline to three hours after treatment |
| Gastrointestinal well-being | assessed by Likert scale | changes from baseline to three hours after treatment |