Cross-linked Emulsion Study

June 21, 2012 updated by: Quadram Institute Bioscience

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UA
        • IFR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

    • Cardiac pacemaker or artificial heart valve
    • Any surgery in the last 6 months
    • Aneurysm clips (metal clips from surgery)
    • Implant, pump or any medical device in the body (eg cochlear implant, neurostimulator, intra-ventricular shunt)
    • Worked with metals (using lathes or grinders) or sustained injury to eyes involving metal splinters or fillings
    • Have artificial eyes or limbs
    • Have been injured with shrapnel or bullets
    • Suffer from fits, blackouts or epilepsy
    • Claustrophobia sufferer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: transglutaminase cross-linking of emulsion
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
This study will assess whether a subtle change in food structure (cross-linking of interfacial protein) can alter gastric emptying rate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of gastric emptying by MRI
Time Frame: 20 minute intervals over 3 hours
rate measured from MRI images of gastric contents
20 minute intervals over 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric emptying by C13
Time Frame: every 20 minutes over 3 hours
compare gastric emptying rates measured by MRI with those measured by 13C acetic acid breath tests.
every 20 minutes over 3 hours
mass spectrometry detection of GI tract hormones in saliva
Time Frame: every 20 minutes over 3 hours
every 20 minutes over 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quadram Institute Bioscience

Collaborators

Norfolk and Norwich University Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Alan R Mackie, PhD, Quadram Institute Bioscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 8, 2011

First Submitted That Met QC Criteria

April 8, 2011

First Posted (Estimate)

April 11, 2011

Study Record Updates

Last Update Posted (Estimate)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IFR04/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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