- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01383902
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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- 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
-
-
Norfolk
-
Norwich, Norfolk, United Kingdom, NR4 7UA
- Institute of Food Research
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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
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 |
Intervention / Treatment |
---|---|
Other: dessert / chocolate
|
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
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
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
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
May 1, 2009
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
June 24, 2011
First Submitted That Met QC Criteria
June 27, 2011
First Posted (Estimate)
June 28, 2011
Study Record Updates
Last Update Posted (Estimate)
June 28, 2011
Last Update Submitted That Met QC Criteria
June 27, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Other Study ID 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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