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Chocolate Meal Study

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ClinicalTrials.gov Identifier: NCT01383902
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : June 28, 2011
Sponsor:
Collaborator:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Information provided by:
Quadram Institute Bioscience

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Impact of Food Composition on Gastric Emptying Other: Food type Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: The Effect of Meal Type on the Rate of Gastric Emptying
Study Start Date : May 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : November 2009
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383902


Locations
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United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY
Sponsors and Collaborators
Quadram Institute Bioscience
Norfolk and Norwich University Hospitals NHS Foundation Trust
More Information
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Responsible Party: Alan Mackie / Research Leader, Institute of Food Research
ClinicalTrials.gov Identifier: NCT01383902    
Other Study ID Numbers: IFR03/2008
First Posted: June 28, 2011    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011