Effects of Cocoa on Gastrointestinal Function

University Hospital, Basel, Switzerland16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Gastrointestinal and Digestive Disorder

Interventions

Dark chocolate barDIETARY_SUPPLEMENT

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 mousseDIETARY_SUPPLEMENT

Dark chocolate mousse (150g, \~500kcal, \~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.

White chocolate barDIETARY_SUPPLEMENT

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 mousseDIETARY_SUPPLEMENT

White chocolate mousse (150g, \~500kcal, \~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Gastric emptying half time

assessed by scintigraphy

Time frame: Baseline until 2 hours postingestion

Secondary Outcomes

Oro-caecal transit time (OCTT)

assessed by scintigraphy and 13-C Lactose-Ureide

Time frame: Baseline until 3 hours postingestion

Colonic transit time

assessed by radio-opaque marker technique

Time frame: Baseline until 3 days after ingestion

Post-prandial satiety

assessed by visual analogue scales

Time frame: changes from baseline to three hours after treatment

Gastrointestinal well-being

assessed by Likert scale