Effects of Cocoa on Gastrointestinal Function

Not Applicable

Completed

• Conditions: Gastrointestinal and Digestive Disorder
• Interventions: Dietary Supplement: Dark chocolate bar; Dietary Supplement: Dark chocolate mousse; Dietary Supplement: White chocolate bar; Dietary Supplement: White chocolate mousse

• Registration Number: NCT03022955
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-18
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-09
• Last Update Posted: 2018-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dark chocolate: FDG-PET	Dark chocolate bar	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)
Dark chocolate: Physiological Measurement	Dark chocolate mousse	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.
White chocolate: FDG-PET	White chocolate bar	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.
White chocolate: Physiological Measurement	White chocolate mousse	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.

Primary Outcome Measures

Name	Time	Method
Gastric emptying half time	Baseline until 2 hours postingestion	assessed by scintigraphy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St Claraspital; 🇨🇭 Basel, Switzerland