Effects of Cocoa on Gastrointestinal Function

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.

Conditions

• Gastrointestinal and Digestive Disorder

Interventions

DIETARY_SUPPLEMENT

Dark chocolate bar

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.

DIETARY_SUPPLEMENT

Dark chocolate mousse

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

DIETARY_SUPPLEMENT

White chocolate bar

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.

DIETARY_SUPPLEMENT

White chocolate mousse

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland

  lead OTHER

Principal Investigators

• Mark Fox, Prof. Dr. · St. Claraspital Basel, Abdominal Center: Gastroenterology

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2017-06-30

Completion

2017-06-30

Countries

• Switzerland

Study Locations