Effects of Cocoa on Gastrointestinal Function

University Hospital Basel

Status: Completed

Conditions: Gastrointestinal and Digestive Disorder

Treatments: Dietary Supplement: Dark chocolate mousse; Dietary Supplement: White chocolate mousse; Dietary Supplement: Dark chocolate bar; Dietary Supplement: White chocolate bar

Study type: Interventional

Funder types: Other

Identifiers

NCT03022955

Chocolate Study

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 4 patient groups, including a placebo group

Dark chocolate: FDG-PET

Active Comparator group

Description:

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)

Treatment:

Dietary Supplement: Dark chocolate bar

Dark chocolate: Physiological Measurement

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Dark chocolate mousse

White chocolate: FDG-PET

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: White chocolate bar

White chocolate: Physiological Measurement

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: White chocolate mousse