Clinical trial NCT01333020: Cross-linked Emulsion Study
Official title: A Pilot Study on the Effect of Protein Cross-linking on Gastric Layering and Emptying of a Food Emulsion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: emulsion
protein
cross-linking
gastric emptying
Lead sponsor: Quadram Institute Bioscience
Sponsor class: OTHER
Collaborators: name: Norfolk and Norwich University Hospitals NHS Foundation Trust
First posted: 2011-04-11
Enrollment: 4
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Rate of gastric emptying by MRI
timeFrame: 20 minute intervals over 3 hours
Secondary outcomes:
measure: Gastric emptying by C13
timeFrame: every 20 minutes over 3 hours
measure: mass spectrometry detection of GI tract hormones in saliva
timeFrame: every 20 minutes over 3 hours
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: IFR
state: Norfolk
Study officials:
affiliation: Quadram Institute Bioscience
name: Alan R Mackie, PhD
role: PRINCIPAL_INVESTIGATOR
References: