Effects of Cocoa on Gastrointestinal Function

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Cocoa Solids on Gastrointestinal Transit, Postprandial Sensation and Gastrointestinal Well-being: a Randomized, Controlled Trial in Healthy Volunteers

Conditions
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Gastrointestinal and Digestive Disorder

Intervention / Treatment
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* Dietary Supplement: Dark chocolate bar
* Dietary Supplement: Dark chocolate mousse
* Dietary Supplement: White chocolate bar
* Dietary Supplement: White chocolate mousse


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dark chocolate: FDG-PET<br>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<br>* 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.<br>|
| Active Comparator: Dark chocolate: Physiological Measurement<br>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<br>* Dark chocolate mousse (150g,  500kcal,  50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.<br>|
| Placebo Comparator: White chocolate: FDG-PET<br>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<br>* 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.<br>|
| Placebo Comparator: White chocolate: Physiological Measurement<br>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<br>* White chocolate mousse (150g,  500kcal,  50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying half time | assessed by scintigraphy | Baseline until 2 hours postingestion | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |