Chocolate Meal Study

June 27, 2011 updated by: Quadram Institute Bioscience

The Effect of Meal Type on the Rate of Gastric Emptying

This comparative pilot study is designed to compare the rates of gastric emptying and by inference rates of digestion of challenge meals. Two types of meal will be compared, chocolate mousse style dessert and chocolate bars. The information from this study will then be compared to the elicitation times for both objective and subjective symptoms in the allergic patients who have been challenged in a different study using the same two meals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UA
        • Institute of Food Research
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male (hormonal status of women would introduce more variation within small group)
  • Age 20-50y
  • BMI 19-30
  • Nominally healthy
  • Normally eat lunch
  • Willing to eat dark chocolate bars and chocolate dessert.
  • Provides informed written consent

Exclusion Criteria:

  • Smokers or smoked within the last year (smoking affects satiety/hunger and volunteer's will not be able to smoke during the study day at the hospital)
  • Diagnosed with any long term illness requiring active treatment e.g. diabetes, cancer, cardiovascular disease
  • Have had surgery on the stomach or intestine or suffered from gastrointestinal disease.
  • Regular (more than once in 10 days) use of antacids, laxatives
  • Diagnosis with any mouth, dental, throat or digestive problem that may affect normal eating and digestion of food.
  • Volunteers taking part in another study (other than a questionnaire based study).
  • Blood pressure greater than 160/100 or less than 90/50 or 95/55 if symptomatic.
  • Individuals with special dietary requirements (eg vegetarians)
  • People with eating disorders (eg. anorexia, bulimia)
  • If any of the clinical screening results are indicative of a health problem which would affect the volunteers well-being or which would affect the study data.
  • Refusal to give permission to inform GP of participation in study
  • Allergic to any of the constituents of the test meal
  • Recent unexplained weight gain or loss
  • History of back problems or any other condition which limit ability to repeatedly sit up and lie down
  • Hiatus Hernia

  • MRI scanning specific exclusion criteria

    • Cardiac pacemaker or artificial heart valve
    • Head surgery or any surgery in the last 6 months
    • Aneurysm clips (metal clips from surgery)
    • Implant, pump or any medical device in the body (eg cochlear implant, neurostimulator, intra-venticular shunt)
    • Worked with metals (using lathes or grinders) or sustained injury to eyes involving metal splinters or fillings
    • Have artificial eyes or limbs
    • Have been injured with shrapnel or bullets
    • Suffer from fits, blackouts or epilepsy
    • Claustrophobia sufferer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: dessert / chocolate
Other: Food type
1ml, 1ml, 5ml, 50ml, 6ml, 20ml, 60ml and 200ml of chocolate dessert or 1 g, 1 segment (5 segments to a bar) repeated 6 times, 2 bars repeated twice of chocolate bars

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
A series of MRI images of the abdomen giving gastric emptying and layering data
Time Frame: 4 hours
To produce gastric emptying and layering data from MRI images on healthy volunteers using a nine differing dose protocol in two different foods.
4 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Use of MRI for measuring gastric emptying rates
Time Frame: 4 hours
An additional underpinning objective is to evaluate and optimise the MRI method for imaging gastric function as a reliable tool for future clinical and nutritional research.
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Quadram Institute Bioscience

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norfolk and Norwich University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IFR03/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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