Gastric Layering Study

NCT01565057 | Completed DMC

• 1 other identifier: IFR07/2010
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

emulsion; emptying; protein; layering

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Fullness and satiety from visual analogue scores

  3.5 hours

• levels of CCK in the blood

  3.5 hours

Study Arms (1)

sedimenting meal

EXPERIMENTAL

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.

Other: sedimenting meal

Interventions

sedimenting meal 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.

sedimenting meal

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator
• Top Institute Food and Nutrition: collaborator

Study Sites (1)

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Study Officials

• Alan R Mackie, PhD

  Quadram Institute Bioscience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 28, 2012
• Study Start: August 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 7, 2012

Record last verified: 2012-05

Locations

GB (1)