Cross-linked Emulsion Study

This study has been completed.
Sponsor:
Collaborator:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Institute of Food Research
ClinicalTrials.gov Identifier:
NCT01333020
First received: April 8, 2011
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Healthy Volunteers
Other: cross-linking of an emulsion drink

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: A Pilot Study on the Effect of Protein Cross-linking on Gastric Layering and Emptying of a Food Emulsion

Further study details as provided by Institute of Food Research:

Primary Outcome Measures:
  • Rate of gastric emptying by MRI [ Time Frame: 20 minute intervals over 3 hours ] [ Designated as safety issue: No ]
    rate measured from MRI images of gastric contents


Secondary Outcome Measures:
  • Gastric emptying by C13 [ Time Frame: every 20 minutes over 3 hours ] [ Designated as safety issue: No ]
    compare gastric emptying rates measured by MRI with those measured by 13C acetic acid breath tests.

  • mass spectrometry detection of GI tract hormones in saliva [ Time Frame: every 20 minutes over 3 hours ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: November 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333020

Locations
United Kingdom
IFR
Norwich, Norfolk, United Kingdom, NR4 7UA
Sponsors and Collaborators
Institute of Food Research
Norfolk and Norwich University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Alan R Mackie, PhD Institute of Food Research
  More Information

No publications provided

Responsible Party: Institute of Food Research
ClinicalTrials.gov Identifier: NCT01333020     History of Changes
Other Study ID Numbers: IFR04/2010
Study First Received: April 8, 2011
Last Updated: June 21, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Institute of Food Research:
emulsion
protein
cross-linking
gastric emptying

ClinicalTrials.gov processed this record on October 20, 2014