Skip to main content
OpenTrials
Completed

NCT Number: NCT03022955

Effects of Cocoa on Gastrointestinal Function

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Claraspital

Basel, 4016, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dark chocolate bar

Dietary 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 mousse

Dietary Supplement

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

White chocolate bar

Dietary 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 mousse

Dietary Supplement

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

Primary outcomes

  1. Gastric emptying half time

    Time frame: Baseline until 2 hours postingestion

    assessed by scintigraphy

Secondary outcomes

  1. Oro-caecal transit time (OCTT)

    Time frame: Baseline until 3 hours postingestion

    assessed by scintigraphy and 13-C Lactose-Ureide

  2. Colonic transit time

    Time frame: Baseline until 3 days after ingestion

    assessed by radio-opaque marker technique

  3. Post-prandial satiety

    Time frame: changes from baseline to three hours after treatment

    assessed by visual analogue scales

  4. Gastrointestinal well-being

    Time frame: changes from baseline to three hours after treatment

    assessed by Likert scale

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Effects of Cocoa Solids on Gastrointestinal Transit, Postprandial Sensation and Gastrointestinal Well-being: a Randomized, Controlled Trial in Healthy Volunteers

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2017
Registry last updated
Feb 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.