Gastric Layering Study

NCT ID: NCT01565057

Last Updated: 2012-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-05-31

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.

Conditions

Healthy Volunteers

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

sedimenting meal

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Norfolk and Norwich University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Top Institute Food and Nutrition

OTHER

Sponsor Role: collaborator

Quadram Institute Bioscience

OTHER

Sponsor Role: lead

Responsible Party

Alan Mackie

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan R Mackie, PhD

Role: PRINCIPAL_INVESTIGATOR

Quadram Institute Bioscience

Locations

Institute of Food Research

Norwich, Norfolk, United Kingdom

Countries

United Kingdom

Other Identifiers

IFR07/2010

Identifier Type: -

Identifier Source: org_study_id