Gastric Layering Study

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: sedimenting meal

• Registration Number: NCT01565057
• Lead Sponsor: Quadram Institute Bioscience

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-28
• Primary Completion: 2012-04
• Status Verified: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sedimenting meal	sedimenting meal	To assess whether rates of gastric emptying of a specifically formulated emulsion drink are significantly different from a control drink and that this in turn leads to differences in satiation (cessation in the desire to eat) and satiety (desire to limit further food intake) as measured by visual analogue scale (VAS) satiety questionnaire and blood CCK.

Primary Outcome Measures

Name	Time	Method
Gastric emptying rates	3 hours	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.

Secondary Outcome Measures

Name	Time	Method
Fullness and satiety from visual analogue scores	3.5 hours	To correlate gastric emptying rates with satiety responses after the meal
levels of CCK in the blood	3.5 hours	To correlate gastric emptying rates with levels of the GI hormone CCK in blood

Trial Locations

Locations (1)

Institute of Food Research; 🇬🇧 Norwich, Norfolk, United Kingdom