Clinical trial NCT03022955: Effects of Cocoa on Gastrointestinal Function
Official title: Effects of Cocoa Solids on Gastrointestinal Transit, Postprandial Sensation and Gastrointestinal Well-being: a Randomized, Controlled Trial in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal and Digestive Disorder
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Gastric emptying half time
timeFrame: Baseline until 2 hours postingestion
Secondary outcomes:
measure: Oro-caecal transit time (OCTT)
timeFrame: Baseline until 3 hours postingestion
measure: Colonic transit time
timeFrame: Baseline until 3 days after ingestion
measure: Post-prandial satiety
timeFrame: changes from baseline to three hours after treatment
measure: Gastrointestinal well-being
timeFrame: changes from baseline to three hours after treatment
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St Claraspital
Study officials:
affiliation: St. Claraspital Basel, Abdominal Center: Gastroenterology
name: Mark Fox, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: