St Claraspital
Basel, 4016, Switzerland
NCT Number: NCT03022955
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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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Basel, 4016, Switzerland
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Dark chocolate mousse (150g, ~500kcal, ~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.
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 (150g, ~500kcal, ~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.
Time frame: Baseline until 2 hours postingestion
assessed by scintigraphy
Time frame: Baseline until 3 hours postingestion
assessed by scintigraphy and 13-C Lactose-Ureide
Time frame: Baseline until 3 days after ingestion
assessed by radio-opaque marker technique
Time frame: changes from baseline to three hours after treatment
assessed by visual analogue scales
Time frame: changes from baseline to three hours after treatment
assessed by Likert scale
University Hospital, Basel, Switzerland
Other
Effects of Cocoa Solids on Gastrointestinal Transit, Postprandial Sensation and Gastrointestinal Well-being: a Randomized, Controlled Trial in Healthy Volunteers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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