Gastric Layering Study
This comparative study is designed to compare the gastric layering and rates of emptying and by inference rates of digestion of two food emulsions. Two types of dairy based foods will be used, one which will sediment in the stomach and one that will not. On each of two study days, a total of 9 post drink MRI scans will be taken to assess gastric layering and emptying. Cannulation will allow blood samples to be taken periodically for subsequent analysis for the presence of specific digestion related hormones. A total volume of 36 ml of blood will be removed and volunteers will also be asked to complete a questionnaire at predetermined times to assess feelings of satiation.
|Study Design:||Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Study on the Effect of Gastric Layering and Emptying Induced by a Food Emulsion|
- Gastric emptying rates [ Time Frame: 3 hours ] [ Designated as safety issue: No ]The primary objective is to measure gastric emptying rates and layering patterns as a function of time in healthy volunteers using two different meals, one which sediments gastric digestion and one in which it does not.
- Fullness and satiety from visual analogue scores [ Time Frame: 3.5 hours ] [ Designated as safety issue: No ]To correlate gastric emptying rates with satiety responses after the meal
- levels of CCK in the blood [ Time Frame: 3.5 hours ] [ Designated as safety issue: No ]To correlate gastric emptying rates with levels of the GI hormone CCK in blood
|Study Start Date:||August 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: sedimenting meal
To assess whether rates of gastric emptying of a specifically formulated emulsion drink are significantly different from a control drink and that this in turn leads to differences in satiation (cessation in the desire to eat) and satiety (desire to limit further food intake) as measured by visual analogue scale (VAS) satiety questionnaire and blood CCK.
Other: sedimenting meal
The active system quickly forms a sedimenting layer of small particles that contain most of the caloric content of the system. This system is made by adding finely grated cheese (particle size 0.5-2 mm) to yoghurt and consumption is followed by drinking 327 ml water.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565057
|Institute of Food Research|
|Norwich, Norfolk, United Kingdom, NR4 7UA|
|Principal Investigator:||Alan R Mackie, PhD||Institute of Food Research|