Impact of Food Composition on Gastric Emptying
Conditions
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.
Interventions
OTHERFood 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
Sponsors
Norfolk and Norwich University Hospitals NHS Foundation Trust
Quadram Institute Bioscience
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Outcome results
None listed