Gastrointestinal and Digestive Disorder Clinical Trial
Official title:
Effects of Cocoa Solids on Gastrointestinal Transit, Postprandial Sensation and Gastrointestinal Well-being: a Randomized, Controlled Trial in Healthy Volunteers
| Verified date | February 2018 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | June 2017 |
| Est. primary completion date | June 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | St Claraspital | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Gastric emptying half time | assessed by scintigraphy | Baseline until 2 hours postingestion | |
| Secondary | Oro-caecal transit time (OCTT) | assessed by scintigraphy and 13-C Lactose-Ureide | Baseline until 3 hours postingestion | |
| Secondary | Colonic transit time | assessed by radio-opaque marker technique | Baseline until 3 days after ingestion | |
| Secondary | Post-prandial satiety | assessed by visual analogue scales | changes from baseline to three hours after treatment | |
| Secondary | Gastrointestinal well-being | assessed by Likert scale | changes from baseline to three hours after treatment |