Effects of Cocoa on Gastrointestinal Function
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Dark chocolate: FDG-PET 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) |
Dietary Supplement: Dark 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.
|
| Active Comparator: Dark chocolate: Physiological Measurement 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. |
Dietary Supplement: Dark chocolate mousse
Dark chocolate mousse (150g, ~500kcal, ~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.
|
| Placebo Comparator: White chocolate: FDG-PET 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. |
Dietary Supplement: White 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.
|
| Placebo Comparator: White chocolate: Physiological Measurement 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. |
Dietary Supplement: White chocolate mousse
White chocolate mousse (150g, ~500kcal, ~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.
|
Outcome Measures
Primary Outcome Measures
- Gastric emptying half time [Baseline until 2 hours postingestion]
assessed by scintigraphy
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy volunteers (men and women)
-
aged 18-65 years
-
body mass index 18-30kg/m2.
Exclusion Criteria:
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special dietary requirements incompatible with dietary intervention (food allergies or intolerances)
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clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) that preclude intake of test meals
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participation in another study with investigational drug within the 30 days preceding and during the present study (purely diagnostic studies are acceptable)
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individuals unwilling to provide written informed consent
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inability to follow the procedures of the study, e.g. due to language problems (all study documents in English)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St Claraspital | Basel | Switzerland | 4016 |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
Investigators
- Principal Investigator: Mark Fox, Prof. Dr., St. Claraspital Basel, Abdominal Center: Gastroenterology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Chocolate Study