Clinical trial NCT01565057: Gastric Layering Study
Official title: A Study on the Effect of Gastric Layering and Emptying Induced by a Food Emulsion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: emulsion
emptying
protein
layering
Lead sponsor: Quadram Institute Bioscience
Sponsor class: OTHER
Collaborators: name: Norfolk and Norwich University Hospitals NHS Foundation Trust
name: Top Institute Food and Nutrition
First posted: 2012-03-28
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This comparative study is designed to compare the gastric layering and rates of emptying and by inference rates of digestion of two food emulsions. Two types of dairy based foods will be used, one which will sediment in the stomach and one that will not. On each of two study days, a total of 9 post drink MRI scans will be taken to assess gastric layering and emptying. Cannulation will allow blood samples to be taken periodically for subsequent analysis for the presence of specific digestion related hormones. A total volume of 36 ml of blood will be removed and volunteers will also be asked to complete a questionnaire at predetermined times to assess feelings of satiation.


Eligibility criteria: Inclusion Criteria:

* Male (hormonal status of women would introduce more variation within small group)
* Age 20-50y
* BMI 19-30
* Apparently healthy
* Normally eat lunch
* Willing to eat the finely grated cheese meal
* Provide written informed consent

Exclusion Criteria:

* Individuals with an intolerance or allergy to any of the constituents of the test meal
* 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
* Regular (more than once in 10 days) use of antacids, laxatives
* Any problems with swallowing
* 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)
* If attended a study during the previous four months where combined blood sampling from previous study and present study would exceed 470mL.
* 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
* 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-venticular 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: Gastric emptying rates
timeFrame: 3 hours
Secondary outcomes:
measure: Fullness and satiety from visual analogue scores
timeFrame: 3.5 hours
measure: levels of CCK in the blood
timeFrame: 3.5 hours
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Institute of Food Research
state: Norfolk
Study officials:
affiliation: Quadram Institute Bioscience
name: Alan R Mackie, PhD
role: PRINCIPAL_INVESTIGATOR
References: