Cross-linked Emulsion Study

NCT01333020 | Completed DMC

• 1 other identifier: IFR04/2010
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Healthy Volunteers

Keywords

emulsion; protein; cross-linking; gastric emptying

Outcome Measures

Primary Outcomes (1)

• Rate of gastric emptying by MRI

  rate measured from MRI images of gastric contents

  20 minute intervals over 3 hours

Secondary Outcomes (2)

• Gastric emptying by C13

  every 20 minutes over 3 hours

• mass spectrometry detection of GI tract hormones in saliva

  every 20 minutes over 3 hours

Study Arms (1)

transglutaminase cross-linking of emulsion

EXPERIMENTAL

The impact of enzyme cross linking of the protein stabilising the test emulsion on gastric emptying rate will be assessed. In this crossover study the subjects will also consume ( on a separate day)an emulsion of the same formulation but not cross-linked.

Other: cross-linking of an emulsion drink

Interventions

cross-linking of an emulsion drink OTHER

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

transglutaminase cross-linking of emulsion

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male (hormonal status of women would introduce more variation within small group)
• Age 20-50 years
• BMI 19-30
• Apparently healthy
• Normally eat lunch
• Willing to eat the "milkshake" style emulsion
• Provides written informed consent

You may not qualify if:

• You have an allergy or intolerance to rape seed oil, milk or milk proteins including lactose
• Smokers or smoked within the last year (smoking affects satiety/hunger)
• 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, whether diagnosed or self reported
• A history of TB or hepatitis.
• 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.
• Take prescription medication for digestive or gastrointestinal conditions.
• 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

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

IFR

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Study Officials

• Alan R Mackie, PhD

  Quadram Institute Bioscience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 11, 2011
• Study Start: November 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

GB (1)