Effects of Cocoa on Gastrointestinal Function

NCT03022955 | Completed

• 1 other identifier: Chocolate Study
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal and Digestive Disorder

Outcome Measures

Primary Outcomes (1)

• Gastric emptying half time

  assessed by scintigraphy

  Baseline until 2 hours postingestion

Secondary Outcomes (4)

• Oro-caecal transit time (OCTT)

  Baseline until 3 hours postingestion

• Colonic transit time

  Baseline until 3 days after ingestion

• Post-prandial satiety

  changes from baseline to three hours after treatment

• Gastrointestinal well-being

  changes from baseline to three hours after treatment

Study Arms (4)

Dark chocolate: FDG-PET

ACTIVE COMPARATOR

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)

Dietary Supplement: Dark chocolate bar

Dark chocolate: Physiological Measurement

ACTIVE COMPARATOR

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.

Dietary Supplement: Dark chocolate mousse

White chocolate: FDG-PET

PLACEBO COMPARATOR

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.

Dietary Supplement: White chocolate bar

White chocolate: Physiological Measurement

PLACEBO COMPARATOR

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.

Dietary Supplement: White chocolate mousse

Interventions

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: 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.

Dark chocolate: Physiological Measurement

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: 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.

White chocolate: Physiological Measurement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers (men and women)
• aged 18-65 years
• body mass index 18-30kg/m2.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

St Claraspital

Basel, 4016, Switzerland

Location

MeSH Terms

Conditions

Digestive System Diseases

Study Officials

• Mark Fox, Prof. Dr.

  St. Claraspital Basel, Abdominal Center: Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 18, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 12, 2018

Record last verified: 2018-02

Locations

CH (1)