Gastric Layering Study

Healthy Volunteers Clinical Trial

Official title:

A Study on the Effect of Gastric Layering and Emptying Induced by a Food Emulsion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565057
• Other study ID #: IFR07/2010
• Status: Completed
• Phase: N/A
• First received: March 23, 2012
• Last updated: May 4, 2012
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Institute of Food Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• sedimenting meal
The active system quickly forms a sedimenting layer of small particles that contain most of the caloric content of the system. This system is made by adding finely grated cheese (particle size 0.5-2 mm) to yoghurt and consumption is followed by drinking 327 ml water.

Locations

Country	Name	City	State
United Kingdom	Institute of Food Research	Norwich	Norfolk

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Food Research	Norfolk and Norwich University Hospitals NHS Foundation Trust, Top Institute Food and Nutrition

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying rates	The primary objective is to measure gastric emptying rates and layering patterns as a function of time in healthy volunteers using two different meals, one which sediments gastric digestion and one in which it does not.	3 hours	No
Secondary	Fullness and satiety from visual analogue scores	To correlate gastric emptying rates with satiety responses after the meal	3.5 hours	No
Secondary	levels of CCK in the blood	To correlate gastric emptying rates with levels of the GI hormone CCK in blood	3.5 hours	No