Clinical Trials Directory

Trials / Completed

CompletedNCT01333020

Cross-linked Emulsion Study

A Pilot Study on the Effect of Protein Cross-linking on Gastric Layering and Emptying of a Food Emulsion

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
4 (actual)
Sponsor
Quadram Institute Bioscience · Academic / Other
Sex
Male
Age
20 Years – 50 Years
Healthy volunteers
Accepted

Summary

This comparative pilot study is designed to compare the rates of gastric emptying and by inference rates of digestion of two food emulsions. Two types of milk protein stabilised food emulsion will be compared, one standard emulsion preparation and one emulsion preparation cross-linked with microbial transglutaminase. The information from this study will then be compared to data on satiety and endocrine hormones from a parallel study undertaken in Finland using the same two meal formulations. The drinks will be labeled with a stable isotope of carbon and samples of breath collected every 20 minutes after consumption of the drink. This will allow gastric residence time to be calculated. The pilot will also fulfill two secondary objectives. At the same time as the breath samples are collected MRI scans of the upper abdomen will be made so that gastric volumes can be measured in order to compare the two methods of measuring gastric emptying rates. Additionally, samples of saliva will also be collected after every MRI scan for subsequent mass spectrometry analysis. These are to assess the efficacy of mass spectrometry analysis for detection of the presence of specific digestion related hormones such as ghrelin.

Conditions

Interventions

TypeNameDescription
OTHERcross-linking of an emulsion drinkThis study will assess whether a subtle change in food structure (cross-linking of interfacial protein) can alter gastric emptying rate.

Timeline

Start date
2010-11-01
Primary completion
2012-06-01
Completion
2012-06-01
First posted
2011-04-11
Last updated
2012-06-22

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01333020. Inclusion in this directory is not an endorsement.