Chocolate Meal Study

Not Applicable

Completed

• Conditions: Impact of Food Composition on Gastric Emptying
• Interventions: Other: Food type

• Registration Number: NCT01383902
• Lead Sponsor: Quadram Institute Bioscience

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-09
• Study Completion: 2009-11
• Status Verified: 2011-06
• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-06-27
• Last Update Submitted: 2011-06-27
• Study First Posted: 2011-06-28
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
dessert / chocolate	Food type	-

Primary Outcome Measures

Name	Time	Method
A series of MRI images of the abdomen giving gastric emptying and layering data	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

Name	Time	Method
Use of MRI for measuring gastric emptying rates	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.

Trial Locations

Locations (2)

Norfolk and Norwich University Hospitals NHS Foundation Trust; 🇬🇧 Norwich, Norfolk, United Kingdom

Institute of Food Research; 🇬🇧 Norwich, Norfolk, United Kingdom