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| Name | Class |
|---|---|
| Norfolk and Norwich University Hospitals NHS Foundation Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dessert / chocolate | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food type | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| A series of MRI images of the abdomen giving gastric emptying and layering data | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Use of MRI for measuring gastric emptying rates | 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 |
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Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Food Research | Norwich | Norfolk | NR4 7UA | United Kingdom | ||
| Norfolk and Norwich University Hospitals NHS Foundation Trust |
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| Norwich |
| Norfolk |
| NR4 7UY |
| United Kingdom |